xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05973838</url>
    </required_header>
    <id_info>
      <org_study_id>1953327</org_study_id>
      <secondary_id>R01DA057443</secondary_id>
      <nct_id>NCT05973838</nct_id>
    </id_info>
    <brief_title>Peer Recovery to Improve Polysubstance Use and Mobile Telemedicine Retention</brief_title>
    <acronym>PRISM</acronym>
    <official_title>Peer-Delivered, Behavioral Activation Intervention to Improve Polysubstance Use and Retention in Mobile Telemedicine OUD Treatment in an Underserved, Rural Area</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Maryland, College Park</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Maryland, Baltimore</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Weill Medical College of Cornell University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>National Institute on Drug Abuse (NIDA)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Maryland, College Park</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to evaluate the feasibility and effectiveness of a peer-led,&#xD;
        brief, behavioral intervention to improve adherence to medication for opioid use disorder&#xD;
        (MOUD) and reduce polysubstance use among patients with OUD and polysubstance use in an&#xD;
        underserved, rural area. The intervention is based on behavioral activation (BA) and is&#xD;
        specifically designed to be implemented by a trained peer recovery specialist. In this&#xD;
        hybrid, Type-1 effectiveness-implementation randomized controlled trial (RCT), the&#xD;
        investigators will evaluate the effectiveness and implementation of Peer Activate vs.&#xD;
        treatment as usual (TAU) over twelve months.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        There is a significant burden of opioid and polysubstance use, disproportionately affecting&#xD;
        underserved, rural areas of the US. Yet many rural communities are poorly equipped to meet&#xD;
        the pressing need for addiction treatment, including medications for OUD (MOUD) and&#xD;
        evidence-based interventions (EBIs) to address the rise in opioid use disorder (OUD) and&#xD;
        co-occurring stimulant use.The availability of telemedicine aboard a mobile treatment unit&#xD;
        (TM-MTU), led by University of Maryland Baltimore in partnership with Maryland Department of&#xD;
        Health, has helped fill the void of rural practitioners by providing buprenorphine for OUD&#xD;
        treatment in rural areas, however, OUD treatment retention remains an ongoing challenge, with&#xD;
        polysubstance use and stimulant use exacerbating this. Peer recovery specialists (PRSs),&#xD;
        trained individuals with their own lived experience with substance use disorder (SUD) and&#xD;
        recovery, are a promising strategy to improve OUD treatment retention and polysubstance use&#xD;
        via the TM-MTU using a reinforcement-based approach.&#xD;
  &#xD;
        Behavioral activation (BA) may be a feasible, scalable, reinforcement-based approach for&#xD;
        improving OUD treatment retention and reducing polysubstance use in rural areas. By targeting&#xD;
        increases in positive reinforcement, BA has been found to be effective for improving SUD&#xD;
        treatment retention, preventing future relapse, including for stimulant use specifically, and&#xD;
        improving medication adherence (i.e., for HIV) among low-income, minority populations with&#xD;
        SUD as well as depression, which is a barrier to MOUD retention. BA has been shown to be&#xD;
        feasibly delivered by peers and community health workers.&#xD;
  &#xD;
        This study proposes to evaluate the effectiveness, implementation, and cost-effectiveness of&#xD;
        an adapted PRS-delivered BA approach on the TM-MTU (&quot;Peer Activate-MTU&quot;) compared to enhanced&#xD;
        treatment as usual (ETAU; facilitated referrals and general PRS support) for patients with&#xD;
        OUD and other polysubstance use. The investigators propose a randomized Type 1 hybrid&#xD;
        effectiveness-implementation trial (n=180) to evaluate Peer Activate-MTU compared to ETAU.&#xD;
        Specific aims are to evaluate the effectiveness of Peer Activate-MTU over 12-months on&#xD;
        polysubstance use, as well as OUD treatment retention and buprenorphine adherence. The&#xD;
        investigators will also evaluate the implementation of Peer-Active-MTU, including&#xD;
        feasibility, acceptability, fidelity, and adoption guided by RE-AIM.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 15, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2027</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2026</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Participants will be randomized in parallel to receive either the Peer Activate intervention on the MTU or enhanced treatment as usual (TAU: treatment as usual services on the MTU in addition to referral to other available services in the community through study contact). Assessments will take place for both groups at baseline, at a midpoint (1-month), and follow ups at 3-month, 6-month and 12-months following the baseline assessment. Follow up assessments will be conducted by a blinded assessor.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>At 3-month, 6-month and 12-months following the baseline assessment, a trained and randomization-blinded member of the research team will complete assessments with the participant.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Six-Month Polysubstance Use Urinalysis</measure>
      <time_frame>Measured from baseline to 6-month follow-up</time_frame>
      <description>Polysubstance use will be assessed using urinalysis. Urine samples are collected at each visit and sent out for toxicological analysis using a customized panel composed of 40 analytes, including both qualitative and quantitative results for opioids, stimulants, benzodiazepines, alcohol, marijuana, hallucinogens, methadone, buprenorphine and norbuprenorphine.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Six-Month Polysubstance Use Self Report</measure>
      <time_frame>Assessed between the baseline assessment 6-month follow-up</time_frame>
      <description>The New York University (NYU) polysubstance use measurement tool will be utilized to assess polysubstance frequency.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Six-month OUD Treatment Retention</measure>
      <time_frame>Measured from intake through 6-month follow up</time_frame>
      <description>Retention is measured using chart review of clinic records of appointment attendance. Retention will be assessed measured as dichotomous retention (yes/no) at six months post MOUD initiation.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Six-month Buprenorphine Adherence</measure>
      <time_frame>Measured from intake to six-month follow-up</time_frame>
      <description>Buprenorphine adherence will be assessed through urinalysis. Urine samples are collected at each visit and sent out for toxicological analysis using a customized panel composed of 40 analytes, including both qualitative and quantitative results for opioids, stimulants, benzodiazepines, alcohol, marijuana, hallucinogens, methadone, buprenorphine and norbuprenorphine. Continuity of pharmacy for MOUD through 6 months will be assessed and calculated via the percent retained on MT for at least 6 months, defined as having one or more additional MOUD-related visits for each 30-day period up to 6 months.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Six-month Self-Report Buprenorphine Adherence</measure>
      <time_frame>Assessed between the baseline assessment and 6-month follow-up</time_frame>
      <description>The IRA Wilson will be utilized to assess self-report buprenorphine adherence</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Six-Month Problems Associated with Substance Use</measure>
      <time_frame>Assessed between the baseline assessment and 6-month follow-up</time_frame>
      <description>Problems associated with use will be assessed using the Short Inventory of Problems (SIP), a 15-item measure that will be used to assess five domains of impairment related to polysubstance use.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Intervention Uptake</measure>
      <time_frame>Assessed between the baseline assessment and 6-month follow-up</time_frame>
      <description>Feasibility, defined as the suitability and practicability of the approach, will be measured quantitatively as the % of patients who agree to participate in the intervention.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Intervention Session Attendance</measure>
      <time_frame>Assessed between the baseline assessment 6-month follow-up</time_frame>
      <description>Acceptability, defined as satisfaction with or tolerability of the proposed approach, will be measured quantitatively by session attendance. Specifically, % of patients enrolled who attend ≥75% sessions will be measured.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Intervention Fidelity</measure>
      <time_frame>Assessed at the acute post-treatment follow-up (approximately 3-months post-baseline assessment)</time_frame>
      <description>Fidelity, defined as the delivery of the intervention as intended, will be measured based on PRS adherence to the intervention delivery. A random selection of 20% of sessions will be rated for fidelity by an independent rater, and % of intervention components delivered as intended will be measured.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Three-month OUD Treatment Retention</measure>
      <time_frame>Measured from intake through 3-month follow up</time_frame>
      <description>Retention is measured using chart review of clinic records of appointment attendance. Retention will be assessed measured as dichotomous retention (yes/no) at three months post MOUD initiation.</description>
    </other_outcome>
    <other_outcome>
      <measure>Three-Month Polysubstance Use Urinalysis</measure>
      <time_frame>Measured from baseline to 3-month follow-up.</time_frame>
      <description>Polysubstance use will be assessed using urinalysis. Urine samples are collected at each visit and sent out for toxicological analysis using a customized panel composed of 40 analytes, including both qualitative and quantitative results for opioids, stimulants, benzodiazepines, alcohol, marijuana, hallucinogens, methadone, buprenorphine and norbuprenorphine.</description>
    </other_outcome>
    <other_outcome>
      <measure>Three-Month Polysubstance Use Self Report</measure>
      <time_frame>Measured from baseline to 3-month follow-up.</time_frame>
      <description>The New York University (NYU) polysubstance use measurement tool will be utilized to assess polysubstance frequency.</description>
    </other_outcome>
    <other_outcome>
      <measure>Three-Month Problems Associated with Substance Use</measure>
      <time_frame>Assessed between baseline assessment and 3-month follow-up.</time_frame>
      <description>Problems associated with use will be assessed using the Short Inventory of Problems (SIP), a 15-item measure that will be used to assess five domains of impairment related to polysubstance use.</description>
    </other_outcome>
    <other_outcome>
      <measure>Three-month Buprenorphine Adherence</measure>
      <time_frame>Measured over 3 months</time_frame>
      <description>Buprenorphine adherence will be assessed through urinalysis. Urine samples are collected at each visit and sent out for toxicological analysis using a customized panel composed of 40 analytes, including both qualitative and quantitative results for opioids, stimulants, benzodiazepines, alcohol, marijuana, hallucinogens, methadone, buprenorphine and norbuprenorphine. Continuity of pharmacy for MOUD through 3 months will be assessed and calculated via the percent retained on MT for at least 3 months, defined as having one or more additional MOUD-related visits for each 30-day period up to 3 months.</description>
    </other_outcome>
    <other_outcome>
      <measure>Three-month Self-Report Buprenorphine Adherence</measure>
      <time_frame>Assessed between the baseline assessment and 3-month follow-up</time_frame>
      <description>The IRA Wilson will be utilized to assess self-report buprenorphine adherence</description>
    </other_outcome>
    <other_outcome>
      <measure>Twelve-month OUD Treatment Retention</measure>
      <time_frame>Measured from intake through 12-month follow up</time_frame>
      <description>Retention is measured using chart review of clinic records of appointment attendance. Retention will be assessed measured as dichotomous retention (yes/no) at twelve months post MOUD initiation.</description>
    </other_outcome>
    <other_outcome>
      <measure>Twelve-Month Polysubstance Use Urinalysis</measure>
      <time_frame>Measured from baseline to 12-month follow-up.</time_frame>
      <description>Polysubstance use will be assessed using urinalysis. Urine samples are collected at each visit and sent out for toxicological analysis using a customized panel composed of 40 analytes, including both qualitative and quantitative results for opioids, stimulants, benzodiazepines, alcohol, marijuana, hallucinogens, methadone, buprenorphine and norbuprenorphine.</description>
    </other_outcome>
    <other_outcome>
      <measure>Twelve-Month Polysubstance Use Self Report</measure>
      <time_frame>Measured from baseline to 12-month follow-up.</time_frame>
      <description>The New York University (NYU) polysubstance use measurement tool will be utilized to assess polysubstance frequency.</description>
    </other_outcome>
    <other_outcome>
      <measure>Twelve-Month Problems Associated with Substance Use</measure>
      <time_frame>Assessed between the baseline and 12-month follow-up.</time_frame>
      <description>Problems associated with use will be assessed using the Short Inventory of Problems (SIP), a 15-item measure that will be used to assess five domains of impairment related to polysubstance use.</description>
    </other_outcome>
    <other_outcome>
      <measure>Twelve-month Buprenorphine Adherence</measure>
      <time_frame>Measured over 12 months</time_frame>
      <description>Buprenorphine adherence will be assessed through urinalysis. Urine samples are collected at each visit and sent out for toxicological analysis using a customized panel composed of 40 analytes, including both qualitative and quantitative results for opioids, stimulants, benzodiazepines, alcohol, marijuana, hallucinogens, methadone, buprenorphine and norbuprenorphine. Continuity of pharmacy for MOUD through 12 months will be assessed and calculated via the percent retained on MT for at least 12 months, defined as having one or more additional MOUD-related visits for each 30-day period up to 12 months.</description>
    </other_outcome>
    <other_outcome>
      <measure>Twelve-month Self-Report Buprenorphine Adherence</measure>
      <time_frame>Assessed between the baseline assessment and 12-month follow-up</time_frame>
      <description>The IRA Wilson will be utilized to assess self-report buprenorphine adherence</description>
    </other_outcome>
    <other_outcome>
      <measure>Six-month Treatment Cost</measure>
      <time_frame>Measured from baseline to 6-month follow-up</time_frame>
      <description>The resources required to implement and sustain the interventions (Peer Activate-MTU, and ETAU) will be identified via micro-costing techniques, using a tailored version of the Drug Abuse Treatment Cost Analysis Program (DATCAP) instrument, a standardized, customizable tool designed to capture intervention resources in multiple settings for the purpose of estimating costs.</description>
    </other_outcome>
    <other_outcome>
      <measure>Six-month Healthcare Resource Utilization</measure>
      <time_frame>Measured from baseline to 6-month follow-up</time_frame>
      <description>Healthcare Resource Utilization by participants will be self-reported using time-anchoring methodology via the Non-study Medical and Other Services (NMOS) form, and will include non-study MOUD care, inpatient, outpatient, and emergency department services; SUD treatment medications; residential and outpatient SUD treatment days; hospital SUD detoxification days; and mental health treatment.</description>
    </other_outcome>
    <other_outcome>
      <measure>Six-month Health-related Quality of Life</measure>
      <time_frame>Measured from baseline to 6-month follow-up</time_frame>
      <description>Health-related quality of life (HRQoL) will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS)-Preference (PROPr) instrument.</description>
    </other_outcome>
    <other_outcome>
      <measure>Six-month Non-Medical and Other Resource Utilization</measure>
      <time_frame>Measured from baseline to 6-month follow-up</time_frame>
      <description>Use of non-medical and other resources from the societal perspective (e.g., school/workplace productivity, travel time to care, caregiver burden, etc.) will also be self-reported using the NMOS.</description>
    </other_outcome>
    <other_outcome>
      <measure>Six-month Criminal and Legal Activities</measure>
      <time_frame>Measured from baseline to 6-month follow-up</time_frame>
      <description>Criminal and legal activities will be measured using the time-anchoring methodology via the Criminal-Legal Activities Form (CLAF).</description>
    </other_outcome>
    <other_outcome>
      <measure>Overdose risk</measure>
      <time_frame>Measured from baseline to 6-month follow-up</time_frame>
      <description>Overdose risk will be assessed as a binary outcome (including both fatal and non-fatal overdoses).</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">180</enrollment>
    <condition>Polysubstance Addiction</condition>
    <condition>Opioid Medication Assisted Treatment</condition>
    <condition>Treatment Adherence</condition>
    <condition>Retention in Care</condition>
    <condition>Substance-Related Disorders</condition>
    <arm_group>
      <arm_group_label>Peer-Delivered Behavioral Activation (&quot;Peer Activate&quot;)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants in the Peer Activate intervention will receive a PRS-delivered behavioral activation intervention to address barriers to retention in methadone treatment and increase substance-free, positive reinforcement to support retention and reduce polysubstance use.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Treatment As Usual</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Participants in the TAU group will receive enhanced treatment as usual, defined as MTU services as usual enhanced with additional community referrals and follow-ups on those referrals, in addition to regular meetings with an addiction medicine physician and PRS on the MTU. Standard PRS contact typically includes connection to local resources and general peer support as needed.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Peer-Delivered Behavioral Activation (&quot;Peer Activate&quot;)</intervention_name>
      <description>The PRS-delivered Peer Activate intervention will consist of approximately six weekly &quot;core&quot; sessions (approximately 30 minutes-1 hour), and then 6 optional &quot;booster&quot; sessions to reinforce skill practice. In Peer Activate sessions, participants will learn behavioral activation and problem-solving skills to reduce barriers to medication nonadherence and incorporate value-driven, substance-free, rewarding activities into their daily life to reduce polysubstance use and improve retention.</description>
      <arm_group_label>Peer-Delivered Behavioral Activation (&quot;Peer Activate&quot;)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Patient participants in the RCT must be 18 or older; receive OUD treatment as part of the&#xD;
          telemedicine program; and exhibit polysubstance use within the past three-months (i.e., use&#xD;
          of one or more non-prescribed substances (excluding opioids and/or tobacco) by urine&#xD;
          toxicology or self-report.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Demonstrating active, unstable or untreated psychiatric symptoms, including mania&#xD;
               and/or psychosis that would interfere with study participation&#xD;
  &#xD;
            -  Inability to understand the study and provide informed consent in English&#xD;
  &#xD;
            -  Positive pregnancy status at enrollment&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jessica F Magidson, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Maryland, College Park</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Sarah M Kattakuzhy, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Maryland School of Medicine</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Morgan S Anvari, BA</last_name>
      <phone>3014055095</phone>
      <email>manvari@umd.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Maryland Baltimore (UMD Drug Treatment Center)</name>
        <address>
          <city>Baltimore</city>
          <state>Maryland</state>
          <zip>21223</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Heather Fitzsimons</last_name>
        <phone>443-462-3400</phone>
        <email>hfitzsimons@som.umaryland.edu</email>
      </contact>
      <investigator>
        <last_name>Sarah M Kattakuzhy, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Eric Weintraub, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Annabelle M Belcher, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>University of Maryland, College Park</name>
        <address>
          <city>College Park</city>
          <state>Maryland</state>
          <zip>20742</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Morgan S Anvari, BA</last_name>
        <phone>301-405-5095</phone>
        <email>manvari@umd.edu</email>
      </contact>
      <contact_backup>
        <last_name>Jessica F Magidson, PhD</last_name>
        <phone>301-405-5095</phone>
        <email>jmagidso@umd.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Jessica F Magidson, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Caroline County Behavioral Health</name>
        <address>
          <city>Denton</city>
          <state>Maryland</state>
          <zip>21629</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jessica Tuel, MSW</last_name>
        <phone>410-479-8172</phone>
        <email>jessicam.tuel@maryland.gov</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
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    <reference>
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      <PMID>21310539</PMID>
    </reference>
    <reference>
      <citation>Mimiaga MJ, Reisner SL, Pantalone DW, O'Cleirigh C, Mayer KH, Safren SA. A pilot trial of integrated behavioral activation and sexual risk reduction counseling for HIV-uninfected men who have sex with men abusing crystal methamphetamine. AIDS Patient Care STDS. 2012 Nov;26(11):681-93. doi: 10.1089/apc.2012.0216. Epub 2012 Oct 3.</citation>
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    <reference>
      <citation>Mimiaga MJ, Pantalone DW, Biello KB, Hughto JMW, Frank J, O'Cleirigh C, Reisner SL, Restar A, Mayer KH, Safren SA. An initial randomized controlled trial of behavioral activation for treatment of concurrent crystal methamphetamine dependence and sexual risk for HIV acquisition among men who have sex with men. AIDS Care. 2019 Sep;31(9):1083-1095. doi: 10.1080/09540121.2019.1595518. Epub 2019 Mar 19.</citation>
      <PMID>30887824</PMID>
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    <reference>
      <citation>Daughters SB, Magidson JF, Anand D, Seitz-Brown CJ, Chen Y, Baker S. The effect of a behavioral activation treatment for substance use on post-treatment abstinence: a randomized controlled trial. Addiction. 2018 Mar;113(3):535-544. doi: 10.1111/add.14049. Epub 2017 Nov 19.</citation>
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    <reference>
      <citation>Magidson JF, Seitz-Brown CJ, Safren SA, Daughters SB. Implementing Behavioral Activation and Life-Steps for Depression and HIV Medication Adherence in a Community Health Center. Cogn Behav Pract. 2014 Nov 1;21(4):386-403. doi: 10.1016/j.cbpra.2013.10.002.</citation>
      <PMID>25419102</PMID>
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    <reference>
      <citation>Magidson JF, Joska JA, Regenauer KS, Satinsky E, Andersen LS, Seitz-Brown CJ, Borba CPC, Safren SA, Myers B. &quot;Someone who is in this thing that I am suffering from&quot;: The role of peers and other facilitators for task sharing substance use treatment in South African HIV care. Int J Drug Policy. 2019 Aug;70:61-69. doi: 10.1016/j.drugpo.2018.11.004. Epub 2019 May 10.</citation>
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    <reference>
      <citation>Daughters SB, Magidson JF, Schuster RM, Safren SA. ACT HEALTHY: A Combined Cognitive-Behavioral Depression and Medication Adherence Treatment for HIV-Infected Substance Users. Cogn Behav Pract. 2010 Aug 1;17(3):309-321. doi: 10.1016/j.cbpra.2009.12.003.</citation>
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    </reference>
    <reference>
      <citation>Tull MT, Berghoff CR, Bardeen JR, Schoenleber M, Konkle-Parker DJ. An Initial Open Trial of a Brief Behavioral Activation Treatment for Depression and Medication Adherence in HIV-Infected Patients. Behav Modif. 2018 Mar;42(2):196-209. doi: 10.1177/0145445517723901. Epub 2017 Aug 11.</citation>
      <PMID>28799413</PMID>
    </reference>
    <reference>
      <citation>Carroll KM. Lost in translation? Moving contingency management and cognitive behavioral therapy into clinical practice. Ann N Y Acad Sci. 2014 Oct;1327(1):94-111. doi: 10.1111/nyas.12501. Epub 2014 Sep 9.</citation>
      <PMID>25204847</PMID>
    </reference>
    <reference>
      <citation>Magidson JF, Lejuez CW, Kamal T, Blevins EJ, Murray LK, Bass JK, Bolton P, Pagoto S. Adaptation of community health worker-delivered behavioral activation for torture survivors in Kurdistan, Iraq. Glob Ment Health (Camb). 2015 Dec;2:e24. doi: 10.1017/gmh.2015.22.</citation>
      <PMID>27478619</PMID>
    </reference>
    <reference>
      <citation>Richards DA, Ekers D, McMillan D, Taylor RS, Byford S, Warren FC, Barrett B, Farrand PA, Gilbody S, Kuyken W, O'Mahen H, Watkins ER, Wright KA, Hollon SD, Reed N, Rhodes S, Fletcher E, Finning K. Cost and Outcome of Behavioural Activation versus Cognitive Behavioural Therapy for Depression (COBRA): a randomised, controlled, non-inferiority trial. Lancet. 2016 Aug 27;388(10047):871-80. doi: 10.1016/S0140-6736(16)31140-0. Epub 2016 Jul 23.</citation>
      <PMID>27461440</PMID>
    </reference>
    <reference>
      <citation>Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion interventions: the RE-AIM framework. Am J Public Health. 1999 Sep;89(9):1322-7. doi: 10.2105/ajph.89.9.1322.</citation>
      <PMID>10474547</PMID>
    </reference>
    <reference>
      <citation>Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011 Mar;38(2):65-76. doi: 10.1007/s10488-010-0319-7.</citation>
      <PMID>20957426</PMID>
    </reference>
    <reference>
      <citation>Mack KA, Jones CM, Ballesteros MF. Illicit Drug Use, Illicit Drug Use Disorders, and Drug Overdose Deaths in Metropolitan and Nonmetropolitan Areas-United States. Am J Transplant. 2017 Dec;17(12):3241-3252. doi: 10.1111/ajt.14555.</citation>
      <PMID>29145698</PMID>
    </reference>
    <reference>
      <citation>Langabeer JR, Stotts AL, Cortez A, Tortolero G, Champagne-Langabeer T. Geographic proximity to buprenorphine treatment providers in the U.S. Drug Alcohol Depend. 2020 Aug 1;213:108131. doi: 10.1016/j.drugalcdep.2020.108131. Epub 2020 Jun 24.</citation>
      <PMID>32599495</PMID>
    </reference>
    <reference>
      <citation>Magidson JF, Kleinman MB, Bradley V, Anvari MS, Abidogun TM, Belcher AM, Greenblatt AD, Dean D, Hines A, Seitz-Brown CJ, Wagner M, Bennett M, Felton JW. Peer recovery specialist-delivered, behavioral activation intervention to improve retention in methadone treatment: Results from an open-label, Type 1 hybrid effectiveness-implementation pilot trial. Int J Drug Policy. 2022 Oct;108:103813. doi: 10.1016/j.drugpo.2022.103813. Epub 2022 Aug 3.</citation>
      <PMID>35932644</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 7, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Maryland, College Park</investigator_affiliation>
      <investigator_full_name>Jessica Magidson</investigator_full_name>
      <investigator_title>Director and Associate Professor</investigator_title>
    </responsible_party>
    <keyword>Substance-Related Disorders</keyword>
    <keyword>Opioid-Related Disorders</keyword>
    <keyword>Polysubstance Use</keyword>
    <keyword>Mental disorders</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Substance-Related Disorders</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>After all primary analyses are complete, de-identified data will be uploaded to an NIH-supported data repository and/or available by request to the MPIs.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05973838
  org study id: 1953327
  secondary id: R01DA057443
  nct id: NCT05973838
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to evaluate the feasibility and effectiveness of a peer-led,
        brief, behavioral intervention to improve adherence to medication for opioid use disorder
        (MOUD) and reduce polysubstance use among patients with OUD and polysubstance use in an
        underserved, rural area. The intervention is based on behavioral activation (BA) and is
        specifically designed to be implemented by a trained peer recovery specialist. In this
        hybrid, Type-1 effectiveness-implementation randomized controlled trial (RCT), the
        investigators will evaluate the effectiveness and implementation of Peer Activate vs.
        treatment as usual (TAU) over twelve months.
  There is a significant burden of opioid and polysubstance use, disproportionately affecting
        underserved, rural areas of the US. Yet many rural communities are poorly equipped to meet
        the pressing need for addiction treatment, including medications for OUD (MOUD) and
        evidence-based interventions (EBIs) to address the rise in opioid use disorder (OUD) and
        co-occurring stimulant use.The availability of telemedicine aboard a mobile treatment unit
        (TM-MTU), led by University of Maryland Baltimore in partnership with Maryland Department of
        Health, has helped fill the void of rural practitioners by providing buprenorphine for OUD
        treatment in rural areas, however, OUD treatment retention remains an ongoing challenge, with
        polysubstance use and stimulant use exacerbating this. Peer recovery specialists (PRSs),
        trained individuals with their own lived experience with substance use disorder (SUD) and
        recovery, are a promising strategy to improve OUD treatment retention and polysubstance use
        via the TM-MTU using a reinforcement-based approach.
  
        Behavioral activation (BA) may be a feasible, scalable, reinforcement-based approach for
        improving OUD treatment retention and reducing polysubstance use in rural areas. By targeting
        increases in positive reinforcement, BA has been found to be effective for improving SUD
        treatment retention, preventing future relapse, including for stimulant use specifically, and
        improving medication adherence (i.e., for HIV) among low-income, minority populations with
        SUD as well as depression, which is a barrier to MOUD retention. BA has been shown to be
        feasibly delivered by peers and community health workers.
  
        This study proposes to evaluate the effectiveness, implementation, and cost-effectiveness of
        an adapted PRS-delivered BA approach on the TM-MTU ("Peer Activate-MTU") compared to enhanced
        treatment as usual (ETAU; facilitated referrals and general PRS support) for patients with
        OUD and other polysubstance use. The investigators propose a randomized Type 1 hybrid
        effectiveness-implementation trial (n=180) to evaluate Peer Activate-MTU compared to ETAU.
        Specific aims are to evaluate the effectiveness of Peer Activate-MTU over 12-months on
        polysubstance use, as well as OUD treatment retention and buprenorphine adherence. The
        investigators will also evaluate the implementation of Peer-Active-MTU, including
        feasibility, acceptability, fidelity, and adoption guided by RE-AIM.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Participants will be randomized in parallel to receive either the Peer Activate intervention on the MTU or enhanced treatment as usual (TAU: treatment as usual services on the MTU in addition to referral to other available services in the community through study contact). Assessments will take place for both groups at baseline, at a midpoint (1-month), and follow ups at 3-month, 6-month and 12-months following the baseline assessment. Follow up assessments will be conducted by a blinded assessor.
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  masking description: At 3-month, 6-month and 12-months following the baseline assessment, a trained and randomization-blinded member of the research team will complete assessments with the participant.
  measure: Six-Month Polysubstance Use Urinalysis
  time frame: Measured from baseline to 6-month follow-up
  description: Polysubstance use will be assessed using urinalysis. Urine samples are collected at each visit and sent out for toxicological analysis using a customized panel composed of 40 analytes, including both qualitative and quantitative results for opioids, stimulants, benzodiazepines, alcohol, marijuana, hallucinogens, methadone, buprenorphine and norbuprenorphine.
  measure: Six-Month Polysubstance Use Self Report
  time frame: Assessed between the baseline assessment 6-month follow-up
  description: The New York University (NYU) polysubstance use measurement tool will be utilized to assess polysubstance frequency.
  measure: Six-month OUD Treatment Retention
  time frame: Measured from intake through 6-month follow up
  description: Retention is measured using chart review of clinic records of appointment attendance. Retention will be assessed measured as dichotomous retention (yes/no) at six months post MOUD initiation.
  measure: Six-month Buprenorphine Adherence
  time frame: Measured from intake to six-month follow-up
  description: Buprenorphine adherence will be assessed through urinalysis. Urine samples are collected at each visit and sent out for toxicological analysis using a customized panel composed of 40 analytes, including both qualitative and quantitative results for opioids, stimulants, benzodiazepines, alcohol, marijuana, hallucinogens, methadone, buprenorphine and norbuprenorphine. Continuity of pharmacy for MOUD through 6 months will be assessed and calculated via the percent retained on MT for at least 6 months, defined as having one or more additional MOUD-related visits for each 30-day period up to 6 months.
  measure: Six-month Self-Report Buprenorphine Adherence
  time frame: Assessed between the baseline assessment and 6-month follow-up
  description: The IRA Wilson will be utilized to assess self-report buprenorphine adherence
  measure: Six-Month Problems Associated with Substance Use
  time frame: Assessed between the baseline assessment and 6-month follow-up
  description: Problems associated with use will be assessed using the Short Inventory of Problems (SIP), a 15-item measure that will be used to assess five domains of impairment related to polysubstance use.
  measure: Intervention Uptake
  time frame: Assessed between the baseline assessment and 6-month follow-up
  description: Feasibility, defined as the suitability and practicability of the approach, will be measured quantitatively as the % of patients who agree to participate in the intervention.
  measure: Intervention Session Attendance
  time frame: Assessed between the baseline assessment 6-month follow-up
  description: Acceptability, defined as satisfaction with or tolerability of the proposed approach, will be measured quantitatively by session attendance. Specifically, % of patients enrolled who attend ≥75% sessions will be measured.
  measure: Intervention Fidelity
  time frame: Assessed at the acute post-treatment follow-up (approximately 3-months post-baseline assessment)
  description: Fidelity, defined as the delivery of the intervention as intended, will be measured based on PRS adherence to the intervention delivery. A random selection of 20% of sessions will be rated for fidelity by an independent rater, and % of intervention components delivered as intended will be measured.
  measure: Three-month OUD Treatment Retention
  time frame: Measured from intake through 3-month follow up
  description: Retention is measured using chart review of clinic records of appointment attendance. Retention will be assessed measured as dichotomous retention (yes/no) at three months post MOUD initiation.
  measure: Three-Month Polysubstance Use Urinalysis
  time frame: Measured from baseline to 3-month follow-up.
  description: Polysubstance use will be assessed using urinalysis. Urine samples are collected at each visit and sent out for toxicological analysis using a customized panel composed of 40 analytes, including both qualitative and quantitative results for opioids, stimulants, benzodiazepines, alcohol, marijuana, hallucinogens, methadone, buprenorphine and norbuprenorphine.
  measure: Three-Month Polysubstance Use Self Report
  time frame: Measured from baseline to 3-month follow-up.
  description: The New York University (NYU) polysubstance use measurement tool will be utilized to assess polysubstance frequency.
  measure: Three-Month Problems Associated with Substance Use
  time frame: Assessed between baseline assessment and 3-month follow-up.
  description: Problems associated with use will be assessed using the Short Inventory of Problems (SIP), a 15-item measure that will be used to assess five domains of impairment related to polysubstance use.
  measure: Three-month Buprenorphine Adherence
  time frame: Measured over 3 months
  description: Buprenorphine adherence will be assessed through urinalysis. Urine samples are collected at each visit and sent out for toxicological analysis using a customized panel composed of 40 analytes, including both qualitative and quantitative results for opioids, stimulants, benzodiazepines, alcohol, marijuana, hallucinogens, methadone, buprenorphine and norbuprenorphine. Continuity of pharmacy for MOUD through 3 months will be assessed and calculated via the percent retained on MT for at least 3 months, defined as having one or more additional MOUD-related visits for each 30-day period up to 3 months.
  measure: Three-month Self-Report Buprenorphine Adherence
  time frame: Assessed between the baseline assessment and 3-month follow-up
  description: The IRA Wilson will be utilized to assess self-report buprenorphine adherence
  measure: Twelve-month OUD Treatment Retention
  time frame: Measured from intake through 12-month follow up
  description: Retention is measured using chart review of clinic records of appointment attendance. Retention will be assessed measured as dichotomous retention (yes/no) at twelve months post MOUD initiation.
  measure: Twelve-Month Polysubstance Use Urinalysis
  time frame: Measured from baseline to 12-month follow-up.
  description: Polysubstance use will be assessed using urinalysis. Urine samples are collected at each visit and sent out for toxicological analysis using a customized panel composed of 40 analytes, including both qualitative and quantitative results for opioids, stimulants, benzodiazepines, alcohol, marijuana, hallucinogens, methadone, buprenorphine and norbuprenorphine.
  measure: Twelve-Month Polysubstance Use Self Report
  time frame: Measured from baseline to 12-month follow-up.
  description: The New York University (NYU) polysubstance use measurement tool will be utilized to assess polysubstance frequency.
  measure: Twelve-Month Problems Associated with Substance Use
  time frame: Assessed between the baseline and 12-month follow-up.
  description: Problems associated with use will be assessed using the Short Inventory of Problems (SIP), a 15-item measure that will be used to assess five domains of impairment related to polysubstance use.
  measure: Twelve-month Buprenorphine Adherence
  time frame: Measured over 12 months
  description: Buprenorphine adherence will be assessed through urinalysis. Urine samples are collected at each visit and sent out for toxicological analysis using a customized panel composed of 40 analytes, including both qualitative and quantitative results for opioids, stimulants, benzodiazepines, alcohol, marijuana, hallucinogens, methadone, buprenorphine and norbuprenorphine. Continuity of pharmacy for MOUD through 12 months will be assessed and calculated via the percent retained on MT for at least 12 months, defined as having one or more additional MOUD-related visits for each 30-day period up to 12 months.
  measure: Twelve-month Self-Report Buprenorphine Adherence
  time frame: Assessed between the baseline assessment and 12-month follow-up
  description: The IRA Wilson will be utilized to assess self-report buprenorphine adherence
  measure: Six-month Treatment Cost
  time frame: Measured from baseline to 6-month follow-up
  description: The resources required to implement and sustain the interventions (Peer Activate-MTU, and ETAU) will be identified via micro-costing techniques, using a tailored version of the Drug Abuse Treatment Cost Analysis Program (DATCAP) instrument, a standardized, customizable tool designed to capture intervention resources in multiple settings for the purpose of estimating costs.
  measure: Six-month Healthcare Resource Utilization
  time frame: Measured from baseline to 6-month follow-up
  description: Healthcare Resource Utilization by participants will be self-reported using time-anchoring methodology via the Non-study Medical and Other Services (NMOS) form, and will include non-study MOUD care, inpatient, outpatient, and emergency department services; SUD treatment medications; residential and outpatient SUD treatment days; hospital SUD detoxification days; and mental health treatment.
  measure: Six-month Health-related Quality of Life
  time frame: Measured from baseline to 6-month follow-up
  description: Health-related quality of life (HRQoL) will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS)-Preference (PROPr) instrument.
  measure: Six-month Non-Medical and Other Resource Utilization
  time frame: Measured from baseline to 6-month follow-up
  description: Use of non-medical and other resources from the societal perspective (e.g., school/workplace productivity, travel time to care, caregiver burden, etc.) will also be self-reported using the NMOS.
  measure: Six-month Criminal and Legal Activities
  time frame: Measured from baseline to 6-month follow-up
  description: Criminal and legal activities will be measured using the time-anchoring methodology via the Criminal-Legal Activities Form (CLAF).
  measure: Overdose risk
  time frame: Measured from baseline to 6-month follow-up
  description: Overdose risk will be assessed as a binary outcome (including both fatal and non-fatal overdoses).
  arm group label: Peer-Delivered Behavioral Activation ("Peer Activate")
  arm group type: Experimental
  description: Participants in the Peer Activate intervention will receive a PRS-delivered behavioral activation intervention to address barriers to retention in methadone treatment and increase substance-free, positive reinforcement to support retention and reduce polysubstance use.
  arm group label: Treatment As Usual
  arm group type: No Intervention
  description: Participants in the TAU group will receive enhanced treatment as usual, defined as MTU services as usual enhanced with additional community referrals and follow-ups on those referrals, in addition to regular meetings with an addiction medicine physician and PRS on the MTU. Standard PRS contact typically includes connection to local resources and general peer support as needed.
  intervention type: Behavioral
  intervention name: Peer-Delivered Behavioral Activation ("Peer Activate")
  description: The PRS-delivered Peer Activate intervention will consist of approximately six weekly "core" sessions (approximately 30 minutes-1 hour), and then 6 optional "booster" sessions to reinforce skill practice. In Peer Activate sessions, participants will learn behavioral activation and problem-solving skills to reduce barriers to medication nonadherence and incorporate value-driven, substance-free, rewarding activities into their daily life to reduce polysubstance use and improve retention.
  arm group label: Peer-Delivered Behavioral Activation ("Peer Activate")
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Jessica F Magidson, PhD
  role: Principal Investigator
  affiliation: University of Maryland, College Park
  last name: Sarah M Kattakuzhy, MD
  role: Principal Investigator
  affiliation: University of Maryland School of Medicine
  last name: Morgan S Anvari, BA
  phone: 3014055095
  email: manvari@umd.edu
  facility: 
  status: Not yet recruiting
  contact: 
  investigator: 
  investigator: 
  investigator: 
  facility: 
  status: Not yet recruiting
  contact: 
  contact backup: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  country: United States
  citation: Ghertner R. U.S. trends in the supply of providers with a waiver to prescribe buprenorphine for opioid use disorder in 2016 and 2018. Drug Alcohol Depend. 2019 Nov 1;204:107527. doi: 10.1016/j.drugalcdep.2019.06.029. Epub 2019 Aug 30.
  PMID: 31525570
  citation: Magidson JF, Gorka SM, MacPherson L, Hopko DR, Blanco C, Lejuez CW, Daughters SB. Examining the effect of the Life Enhancement Treatment for Substance Use (LETS ACT) on residential substance abuse treatment retention. Addict Behav. 2011 Jun;36(6):615-623. doi: 10.1016/j.addbeh.2011.01.016. Epub 2011 Jan 21.
  PMID: 21310539
  citation: Mimiaga MJ, Reisner SL, Pantalone DW, O'Cleirigh C, Mayer KH, Safren SA. A pilot trial of integrated behavioral activation and sexual risk reduction counseling for HIV-uninfected men who have sex with men abusing crystal methamphetamine. AIDS Patient Care STDS. 2012 Nov;26(11):681-93. doi: 10.1089/apc.2012.0216. Epub 2012 Oct 3.
  PMID: 23030605
  citation: Mimiaga MJ, Pantalone DW, Biello KB, Hughto JMW, Frank J, O'Cleirigh C, Reisner SL, Restar A, Mayer KH, Safren SA. An initial randomized controlled trial of behavioral activation for treatment of concurrent crystal methamphetamine dependence and sexual risk for HIV acquisition among men who have sex with men. AIDS Care. 2019 Sep;31(9):1083-1095. doi: 10.1080/09540121.2019.1595518. Epub 2019 Mar 19.
  PMID: 30887824
  citation: Daughters SB, Magidson JF, Anand D, Seitz-Brown CJ, Chen Y, Baker S. The effect of a behavioral activation treatment for substance use on post-treatment abstinence: a randomized controlled trial. Addiction. 2018 Mar;113(3):535-544. doi: 10.1111/add.14049. Epub 2017 Nov 19.
  PMID: 28963853
  citation: Magidson JF, Seitz-Brown CJ, Safren SA, Daughters SB. Implementing Behavioral Activation and Life-Steps for Depression and HIV Medication Adherence in a Community Health Center. Cogn Behav Pract. 2014 Nov 1;21(4):386-403. doi: 10.1016/j.cbpra.2013.10.002.
  PMID: 25419102
  citation: Magidson JF, Joska JA, Regenauer KS, Satinsky E, Andersen LS, Seitz-Brown CJ, Borba CPC, Safren SA, Myers B. "Someone who is in this thing that I am suffering from": The role of peers and other facilitators for task sharing substance use treatment in South African HIV care. Int J Drug Policy. 2019 Aug;70:61-69. doi: 10.1016/j.drugpo.2018.11.004. Epub 2019 May 10.
  PMID: 31082664
  citation: Daughters SB, Magidson JF, Schuster RM, Safren SA. ACT HEALTHY: A Combined Cognitive-Behavioral Depression and Medication Adherence Treatment for HIV-Infected Substance Users. Cogn Behav Pract. 2010 Aug 1;17(3):309-321. doi: 10.1016/j.cbpra.2009.12.003.
  PMID: 21709737
  citation: Tull MT, Berghoff CR, Bardeen JR, Schoenleber M, Konkle-Parker DJ. An Initial Open Trial of a Brief Behavioral Activation Treatment for Depression and Medication Adherence in HIV-Infected Patients. Behav Modif. 2018 Mar;42(2):196-209. doi: 10.1177/0145445517723901. Epub 2017 Aug 11.
  PMID: 28799413
  citation: Carroll KM. Lost in translation? Moving contingency management and cognitive behavioral therapy into clinical practice. Ann N Y Acad Sci. 2014 Oct;1327(1):94-111. doi: 10.1111/nyas.12501. Epub 2014 Sep 9.
  PMID: 25204847
  citation: Magidson JF, Lejuez CW, Kamal T, Blevins EJ, Murray LK, Bass JK, Bolton P, Pagoto S. Adaptation of community health worker-delivered behavioral activation for torture survivors in Kurdistan, Iraq. Glob Ment Health (Camb). 2015 Dec;2:e24. doi: 10.1017/gmh.2015.22.
  PMID: 27478619
  citation: Richards DA, Ekers D, McMillan D, Taylor RS, Byford S, Warren FC, Barrett B, Farrand PA, Gilbody S, Kuyken W, O'Mahen H, Watkins ER, Wright KA, Hollon SD, Reed N, Rhodes S, Fletcher E, Finning K. Cost and Outcome of Behavioural Activation versus Cognitive Behavioural Therapy for Depression (COBRA): a randomised, controlled, non-inferiority trial. Lancet. 2016 Aug 27;388(10047):871-80. doi: 10.1016/S0140-6736(16)31140-0. Epub 2016 Jul 23.
  PMID: 27461440
  citation: Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion interventions: the RE-AIM framework. Am J Public Health. 1999 Sep;89(9):1322-7. doi: 10.2105/ajph.89.9.1322.
  PMID: 10474547
  citation: Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011 Mar;38(2):65-76. doi: 10.1007/s10488-010-0319-7.
  PMID: 20957426
  citation: Mack KA, Jones CM, Ballesteros MF. Illicit Drug Use, Illicit Drug Use Disorders, and Drug Overdose Deaths in Metropolitan and Nonmetropolitan Areas-United States. Am J Transplant. 2017 Dec;17(12):3241-3252. doi: 10.1111/ajt.14555.
  PMID: 29145698
  citation: Langabeer JR, Stotts AL, Cortez A, Tortolero G, Champagne-Langabeer T. Geographic proximity to buprenorphine treatment providers in the U.S. Drug Alcohol Depend. 2020 Aug 1;213:108131. doi: 10.1016/j.drugalcdep.2020.108131. Epub 2020 Jun 24.
  PMID: 32599495
  citation: Magidson JF, Kleinman MB, Bradley V, Anvari MS, Abidogun TM, Belcher AM, Greenblatt AD, Dean D, Hines A, Seitz-Brown CJ, Wagner M, Bennett M, Felton JW. Peer recovery specialist-delivered, behavioral activation intervention to improve retention in methadone treatment: Results from an open-label, Type 1 hybrid effectiveness-implementation pilot trial. Int J Drug Policy. 2022 Oct;108:103813. doi: 10.1016/j.drugpo.2022.103813. Epub 2022 Aug 3.
  PMID: 35932644
  responsible party type: Principal Investigator
  investigator affiliation: University of Maryland, College Park
  investigator full name: Jessica Magidson
  investigator title: Director and Associate Professor
  mesh term: Substance-Related Disorders
  sharing ipd: Yes
  ipd description: After all primary analyses are complete, de-identified data will be uploaded to an NIH-supported data repository and/or available by request to the MPIs.