<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/NCT03799341</url>
  </required_header>
  <id_info>
    <org_study_id>NURA-002-18S</org_study_id>
    <secondary_id>CX001807-01A1</secondary_id>
    <nct_id>NCT03799341</nct_id>
  </id_info>
  <brief_title>Neurocognitive Factors in Substance Use Treatment Response: The Ways of Rewarding Abstinence Project</brief_title>
  <acronym>WRAP</acronym>
  <official_title>Electrophysiological Predictors and Indicators of Contingency Management Treatment Response</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Office of Research and Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VA Office of Research and Development</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The proposed work will investigate changes in brain signaling and cognitive functioning that&#xD;
      support recovery from addiction, as well as use of pretreatment neurocognitive functioning to&#xD;
      inform substance use treatment planning. Substance use disorders are prevalent amongst&#xD;
      Veterans. Cocaine addiction, in particular, has been shown to complicate treatment of other&#xD;
      high priority behavioral health problems in the Veteran population (e.g., PTSD, opioid&#xD;
      addiction). While there are currently no approved medications to support recovery from&#xD;
      cocaine addiction, research indicates that Contingency Management (CM) - a behavioral&#xD;
      intervention for cocaine users - can be effective. However, individual responses are variable&#xD;
      and long-term benefits are limited. This CDA will test a new model of how CM works by&#xD;
      examining brain-based predictors and indicators of treatment response. Results will have&#xD;
      immediate implications for measurement-based implementation of existing CM variants within&#xD;
      the VA, supporting access to the version of CM that is best aligned with each Veteran's&#xD;
      needs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Electrophysiological methods, including event-related potential and functional connectivity&#xD;
      approaches, have potential to clarify mechanisms of substance use treatment response and&#xD;
      characterize individual differences therein. Veterans are disproportionately affected by&#xD;
      disorders of addiction, of which cocaine use disorder (CUD) is particularly problematic due&#xD;
      to high relapse rates and the absence of approved pharmacotherapy options. Behavioral&#xD;
      interventions for CUD have therefore become an important focus and Contingency Management&#xD;
      (CM) has emerged as the best-supported approach. CM involves reinforcing cocaine abstinence&#xD;
      (established through objective testing) with reliable, short-term reward, such as chances to&#xD;
      win prizes (i.e., Prize-Based CM or PBCM). Given robust empirical support, nationwide&#xD;
      dissemination of PBCM has been supported by a VHA initiative since 2011. However, PBCM&#xD;
      response rates are variable and long-term benefits are limited - problems magnified by the&#xD;
      cost of implementation with respect to staffing and prizes. Measurement-based approaches to&#xD;
      PBCM implementation have promise to improve the effectiveness and efficiency of CM&#xD;
      programming but have not yet been investigated within the VA or considered in relation to&#xD;
      promising neuromarkers. Importantly, two versions of PBCM are already utilized at VA sites&#xD;
      and may differentially benefit individuals with distinct neurocognitive profiles.&#xD;
      Specifically, VA PBCM programs employ either abstract (voucher prize) or concrete (tangible&#xD;
      prize) incentives, the latter of which may more effectively incentivize abstinence in&#xD;
      Veterans with poor future-oriented thinking and planning ability. While selection between&#xD;
      existing PBCM variants currently reflects practical considerations only, pretreatment&#xD;
      neurocognitive functioning could meaningfully and realistically inform clinical&#xD;
      decision-making in this regard.&#xD;
&#xD;
      This project aims to advance measurement-based implementation of CM by testing a novel&#xD;
      neurocognitive model with immediate implications for the use of abstract versus concrete PBCM&#xD;
      incentives within the VA. Specifically, the future-minded decision-making (FMDM) model posits&#xD;
      that CM scaffolds future-oriented goal representation and self-control to support abstinence&#xD;
      during in the moment use-related decision-making. For individuals with greater FMDM&#xD;
      impairment, concrete, readily-accessible incentives may be more effective than abstract&#xD;
      voucher-based rewards (which require future-oriented thinking and planning to acquire value).&#xD;
      To test this model, neurocognitive substrates of FMDM will be examined as predictors of&#xD;
      differential treatment response in voucher (VoucherPBCM) versus tangible prize (TangiblePBCM)&#xD;
      versions of PBCM. Treatment-related change in neural and cognitive-behavioral correlates of&#xD;
      FMDM will also be evaluated in PBCM-adherent versus non-adherent subgroups. Veterans with CUD&#xD;
      will be allocated to VoucherPBCM or TangiblePBCM conditions and followed for a 12-week&#xD;
      treatment interval. Pre- and post-treatment electroencephalography (EEG) and&#xD;
      cognitive-behavioral assessments will be used to measure FMDM-related constructs (working&#xD;
      memory, self-control, future-oriented decision-making, future reward representation) and&#xD;
      related neuromarkers. These measures will be investigated as predictors of differential&#xD;
      treatment response in VoucherPBCM versus TangiblePBCM, as well as maintenance of gains during&#xD;
      a post-treatment follow-up period. Change in FMDM-related neural and cognitive measures over&#xD;
      the course of treatment will also be evaluated for evidence of neuroadaptation (e.g., changes&#xD;
      in functional connectivity) and enhancement of FMDM function through PBCM. Taken together,&#xD;
      results of the current research project will represent a first step toward precision&#xD;
      implementation of CM within the VA.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 13, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</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 randomly assigned to receive: (1) 12 weeks of TangiblePBCM (n = 70) or (2) 12 weeks of VoucherPBCM (n = 70). CM recipients will also be followed for 6 months post treatment. The proposed design enables evaluation of CM outcome predictors within 140 CM recipients - both with respect to initial treatment response and longer term (6 month) outcomes. All participants will receive a Baseline Assessment prior to the 12 Week Treatment interval, as well as a Follow-up Assessment at the conclusion of this period. Data from Baseline and Follow-up Assessments will enable longitudinal analysis of treatment-related change in EEG and cognitive-behavioral measures in TangiblePBCM and VoucherPBCM in treatment adherent versus treatment non-adherent subgroups.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>% Cocaine-Negative Urine Specimens</measure>
    <time_frame>12-Week Treatment Interval</time_frame>
    <description>Proportion of urine specimens provided during the 12-week treatment interval that test negative for cocaine.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Longest Duration of Cocaine Abstinence</measure>
    <time_frame>12-Week Treatment Interval</time_frame>
    <description>Longest period of objectively verified abstinence from cocaine during treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>% Contingency Management (CM) Sessions Attended (CM Groups Only)</measure>
    <time_frame>12-Week Treatment Interval</time_frame>
    <description>Proportion of CM treatment sessions attended.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Non-CM Treatment Encounters</measure>
    <time_frame>12-Week Treatment Interval</time_frame>
    <description>Number of non-CM treatment encounters during treatment (documented in chart and/or self-reported)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>% Self-Reported Cocaine-Abstinent Days During Treatment</measure>
    <time_frame>12-Week Treatment Interval</time_frame>
    <description>Proportion of self-reported cocaine-abstinent days during the 12-week treatment interval.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>% Self-Reported Drug- and Alcohol-Abstinent Days During Treatment</measure>
    <time_frame>12-Week Treatment Interval</time_frame>
    <description>Proportion of self-reported drug- and alcohol-abstinent days during the 12-week treatment interval.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>% Self-Reported Stimulant-Abstinent Days at Post-Treatment (CM Groups Only)</measure>
    <time_frame>6 Month Post-Treatment Interval</time_frame>
    <description>Proportion of self-reported stimulant-abstinent days during the 6 month post-treatment interval.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>% Self-Reported Drug- and Alcohol-Abstinent Days at Post-Treatment (CM Groups Only)</measure>
    <time_frame>6 Month Post-Treatment Interval</time_frame>
    <description>Proportion of self-reported drug- and alcohol-abstinent days during the 6 month post-treatment interval.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Pre- to Post-Treatment Change in Theta Synchronization</measure>
    <time_frame>12-Week Treatment Interval</time_frame>
    <description>Treatment-related change in theta synchronization between anterior cingulate cortex and lateral prefrontal cortex during high conflict events in the Parametric Conflict Flankers task.</description>
  </other_outcome>
  <other_outcome>
    <measure>Pre- to Post-Treatment Change in Executive Working Memory</measure>
    <time_frame>12-Week Treatment Interval</time_frame>
    <description>Treatment-related change in Brown-Peterson working memory scores. We will specifically use a modified Brown-Peterson test (Auditory Consonant Trigrams) for which both age- and Veteran-specific norms exist. Summary scores for this measure (including 9-, 18-, and 36-second delay conditions) can range from 0-45, with higher scores indicating improved executive working memory performance.</description>
  </other_outcome>
  <other_outcome>
    <measure>Pre- to Post-Treatment Change in Episodic Future Thinking Effect (Delay Discounting)</measure>
    <time_frame>12-Week Treatment Interval</time_frame>
    <description>Treatment-related change in the difference in delay discounting slopes (ln(k)) estimated for discounting conditions with and without personally meaningful event tags.</description>
  </other_outcome>
  <other_outcome>
    <measure>Pre- to Post-Treatment Change Spontaneous Eyeblink Rate</measure>
    <time_frame>12-Week Treatment Interval</time_frame>
    <description>Treatment-related change in spontaneous eyeblink rate at rest.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">180</enrollment>
  <condition>Cocaine Use Disorder</condition>
  <arm_group>
    <arm_group_label>Tangible Prize-Based Contingency Management (TangiblePBCM)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>For participants assigned to TangiblePBCM, prize draws resulting in one or more small, large, or jumbo wins will result in access to a prize cabinet stocked with small, medium, large, and jumbo financial incentive items. Medium incentive items are included for selection in the event that a patient draws several small prize slips on the same day and are considered equivalent to 4 small prizes. Selection of specific prize items will be informed by patient preference and items will be restocked at least every 2 weeks. The prize cabinet will be open during TangiblePBCM sessions such that prize items are readily visible. Selection of prizes, maintenance of the prize cabinet, and policies regarding prize redemption will follow published guidance on administration of TangiblePBCM within the context of research protocols.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Voucher Prize-Based Contingency Management (VoucherPBCM)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>For participants assigned to VoucherPBCM, prize draws resulting in one or more small, large, or jumbo wins will be reinforced with VA Canteen vouchers in the specified incentive range (i.e., small, large, or jumbo).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Prize-Based Contingency Management</intervention_name>
    <description>Participants assigned to Prize-based Contingency&#xD;
Management (PBCM) conditions will receive PBCM as an adjunct to TAU. PBCM will involve twice weekly one-on-one sessions with a provider for 12-weeks. During each session, a urine specimen provided by the patient will be tested for cocaine using a point-of-care dip-test. Results of point-of-care testing will be shared with the patient and negative results will be reinforced with draws from a fish bowl containing 500 paper slips, 250 of which award small, large, or jumbo prizes (remaining slips deliver words of encouragement). Patients will be reinforced with a single prize draw for their first negative specimen; an additional prize draw will be added for each consecutive negative result (up to 8&#xD;
prize draws per session). Abstinence-contingent prize draws will be reset to one upon either a positive test result or unexcused, missed appointment.</description>
    <arm_group_label>Tangible Prize-Based Contingency Management (TangiblePBCM)</arm_group_label>
    <arm_group_label>Voucher Prize-Based Contingency Management (VoucherPBCM)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Treatment As Usual Outpatient Substance Use Treatment</intervention_name>
    <description>All participants will receive treatment as usual outpatient substance use services during the 12-week treatment interval. TAU will specifically entail recommended participation in at least two outpatient group and/or individual psychotherapy encounters per week within the Center for Treatment of Addictive Disorders (CTAD) at VA Pittsburgh Healthcare System. Participants will additionally continue any previously prescribed pharmacotherapy for substance use and/or other mental health conditions, if applicable.</description>
    <arm_group_label>Tangible Prize-Based Contingency Management (TangiblePBCM)</arm_group_label>
    <arm_group_label>Voucher Prize-Based Contingency Management (VoucherPBCM)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Military Veterans&#xD;
&#xD;
          -  DSM-5 Criteria for Cocaine Use Disorder (Mild, Moderate, or Severe)&#xD;
&#xD;
          -  Cocaine Use Within Past 60 Days&#xD;
&#xD;
          -  Stated Goal of Cocaine Abstinence or Reduced Cocaine Use&#xD;
&#xD;
          -  Normal or Corrected-to-Normal Vision&#xD;
&#xD;
          -  Average or Corrected Hearing&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of Severe Traumatic Brain Injury, Seizure Disorder, or other Neurological&#xD;
             Illness&#xD;
&#xD;
          -  Severe or Unstable Medical or Psychiatric Condition&#xD;
&#xD;
          -  Pregnant or Lactating Women&#xD;
&#xD;
          -  Moderate-to-Severe Neurocognitive Impairment per Medical Record, SLUMS &lt; 21, or Mini&#xD;
             MoCA &lt; 11&#xD;
&#xD;
          -  In Ongoing Residential Treatment or Imminently Expected to Enter Residential Treatment&#xD;
             During the Study Interval at Time of Screening&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sarah E. Forster, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sarah E Forster, PhD</last_name>
    <phone>(412) 360-2365</phone>
    <email>Sarah.Forster2@va.gov</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Stuart R Steinhauer, PhD</last_name>
    <phone>(412) 360-2397</phone>
    <email>Stuart.Steinhauer@va.gov</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15240</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sarah E Forster, PhD</last_name>
      <phone>412-360-2365</phone>
      <email>Sarah.Forster2@va.gov</email>
    </contact>
    <contact_backup>
      <last_name>Stuart R Steinhauer, PhD</last_name>
      <phone>(412) 360-2397</phone>
      <email>Stuart.Steinhauer@va.gov</email>
    </contact_backup>
    <investigator>
      <last_name>Sarah E. Forster, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>March 2, 2023</last_update_submitted>
  <last_update_submitted_qc>March 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cocaine-Related Disorders</keyword>
  <keyword>Contingency Management</keyword>
  <keyword>Reward</keyword>
  <keyword>Choice Behavior</keyword>
  <keyword>Executive Function</keyword>
  <keyword>Precision Medicine</keyword>
  <keyword>Evidence-Based Practice</keyword>
  <keyword>Prospective Thinking</keyword>
  <keyword>Electroencephalography</keyword>
  <keyword>Event-Related Potentials</keyword>
  <keyword>Functional Connectivity</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>If possible, a de-identified, anonymized dataset will be created and shared. However, specific arrangements for sharing have not yet been made and options for data sharing (for example, the availability of data repositories for electroencephalographic data files), as well as VA policies regarding data sharing may change over the course of the study. A detailed plan for data sharing will be developed and approved upon completion of data collection.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03799341
org study id: NURA-002-18S
secondary id: CX001807-01A1
nct id: NCT03799341
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
The proposed work will investigate changes in brain signaling and cognitive functioning that
      support recovery from addiction, as well as use of pretreatment neurocognitive functioning to
      inform substance use treatment planning. Substance use disorders are prevalent amongst
      Veterans. Cocaine addiction, in particular, has been shown to complicate treatment of other
      high priority behavioral health problems in the Veteran population (e.g., PTSD, opioid
      addiction). While there are currently no approved medications to support recovery from
      cocaine addiction, research indicates that Contingency Management (CM) - a behavioral
      intervention for cocaine users - can be effective. However, individual responses are variable
      and long-term benefits are limited. This CDA will test a new model of how CM works by
      examining brain-based predictors and indicators of treatment response. Results will have
      immediate implications for measurement-based implementation of existing CM variants within
      the VA, supporting access to the version of CM that is best aligned with each Veteran's
      needs.
Electrophysiological methods, including event-related potential and functional connectivity
      approaches, have potential to clarify mechanisms of substance use treatment response and
      characterize individual differences therein. Veterans are disproportionately affected by
      disorders of addiction, of which cocaine use disorder (CUD) is particularly problematic due
      to high relapse rates and the absence of approved pharmacotherapy options. Behavioral
      interventions for CUD have therefore become an important focus and Contingency Management
      (CM) has emerged as the best-supported approach. CM involves reinforcing cocaine abstinence
      (established through objective testing) with reliable, short-term reward, such as chances to
      win prizes (i.e., Prize-Based CM or PBCM). Given robust empirical support, nationwide
      dissemination of PBCM has been supported by a VHA initiative since 2011. However, PBCM
      response rates are variable and long-term benefits are limited - problems magnified by the
      cost of implementation with respect to staffing and prizes. Measurement-based approaches to
      PBCM implementation have promise to improve the effectiveness and efficiency of CM
      programming but have not yet been investigated within the VA or considered in relation to
      promising neuromarkers. Importantly, two versions of PBCM are already utilized at VA sites
      and may differentially benefit individuals with distinct neurocognitive profiles.
      Specifically, VA PBCM programs employ either abstract (voucher prize) or concrete (tangible
      prize) incentives, the latter of which may more effectively incentivize abstinence in
      Veterans with poor future-oriented thinking and planning ability. While selection between
      existing PBCM variants currently reflects practical considerations only, pretreatment
      neurocognitive functioning could meaningfully and realistically inform clinical
      decision-making in this regard.

      This project aims to advance measurement-based implementation of CM by testing a novel
      neurocognitive model with immediate implications for the use of abstract versus concrete PBCM
      incentives within the VA. Specifically, the future-minded decision-making (FMDM) model posits
      that CM scaffolds future-oriented goal representation and self-control to support abstinence
      during in the moment use-related decision-making. For individuals with greater FMDM
      impairment, concrete, readily-accessible incentives may be more effective than abstract
      voucher-based rewards (which require future-oriented thinking and planning to acquire value).
      To test this model, neurocognitive substrates of FMDM will be examined as predictors of
      differential treatment response in voucher (VoucherPBCM) versus tangible prize (TangiblePBCM)
      versions of PBCM. Treatment-related change in neural and cognitive-behavioral correlates of
      FMDM will also be evaluated in PBCM-adherent versus non-adherent subgroups. Veterans with CUD
      will be allocated to VoucherPBCM or TangiblePBCM conditions and followed for a 12-week
      treatment interval. Pre- and post-treatment electroencephalography (EEG) and
      cognitive-behavioral assessments will be used to measure FMDM-related constructs (working
      memory, self-control, future-oriented decision-making, future reward representation) and
      related neuromarkers. These measures will be investigated as predictors of differential
      treatment response in VoucherPBCM versus TangiblePBCM, as well as maintenance of gains during
      a post-treatment follow-up period. Change in FMDM-related neural and cognitive measures over
      the course of treatment will also be evaluated for evidence of neuroadaptation (e.g., changes
      in functional connectivity) and enhancement of FMDM function through PBCM. Taken together,
      results of the current research project will represent a first step toward precision
      implementation of CM within the VA.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants will be randomly assigned to receive: (1) 12 weeks of TangiblePBCM (n = 70) or (2) 12 weeks of VoucherPBCM (n = 70). CM recipients will also be followed for 6 months post treatment. The proposed design enables evaluation of CM outcome predictors within 140 CM recipients - both with respect to initial treatment response and longer term (6 month) outcomes. All participants will receive a Baseline Assessment prior to the 12 Week Treatment interval, as well as a Follow-up Assessment at the conclusion of this period. Data from Baseline and Follow-up Assessments will enable longitudinal analysis of treatment-related change in EEG and cognitive-behavioral measures in TangiblePBCM and VoucherPBCM in treatment adherent versus treatment non-adherent subgroups.
primary purpose: Treatment
masking: None (Open Label)
measure: % Cocaine-Negative Urine Specimens
time frame: 12-Week Treatment Interval
description: Proportion of urine specimens provided during the 12-week treatment interval that test negative for cocaine.
measure: Longest Duration of Cocaine Abstinence
time frame: 12-Week Treatment Interval
description: Longest period of objectively verified abstinence from cocaine during treatment.
measure: % Contingency Management (CM) Sessions Attended (CM Groups Only)
time frame: 12-Week Treatment Interval
description: Proportion of CM treatment sessions attended.
measure: Total Non-CM Treatment Encounters
time frame: 12-Week Treatment Interval
description: Number of non-CM treatment encounters during treatment (documented in chart and/or self-reported)
measure: % Self-Reported Cocaine-Abstinent Days During Treatment
time frame: 12-Week Treatment Interval
description: Proportion of self-reported cocaine-abstinent days during the 12-week treatment interval.
measure: % Self-Reported Drug- and Alcohol-Abstinent Days During Treatment
time frame: 12-Week Treatment Interval
description: Proportion of self-reported drug- and alcohol-abstinent days during the 12-week treatment interval.
measure: % Self-Reported Stimulant-Abstinent Days at Post-Treatment (CM Groups Only)
time frame: 6 Month Post-Treatment Interval
description: Proportion of self-reported stimulant-abstinent days during the 6 month post-treatment interval.
measure: % Self-Reported Drug- and Alcohol-Abstinent Days at Post-Treatment (CM Groups Only)
time frame: 6 Month Post-Treatment Interval
description: Proportion of self-reported drug- and alcohol-abstinent days during the 6 month post-treatment interval.
measure: Pre- to Post-Treatment Change in Theta Synchronization
time frame: 12-Week Treatment Interval
description: Treatment-related change in theta synchronization between anterior cingulate cortex and lateral prefrontal cortex during high conflict events in the Parametric Conflict Flankers task.
measure: Pre- to Post-Treatment Change in Executive Working Memory
time frame: 12-Week Treatment Interval
description: Treatment-related change in Brown-Peterson working memory scores. We will specifically use a modified Brown-Peterson test (Auditory Consonant Trigrams) for which both age- and Veteran-specific norms exist. Summary scores for this measure (including 9-, 18-, and 36-second delay conditions) can range from 0-45, with higher scores indicating improved executive working memory performance.
measure: Pre- to Post-Treatment Change in Episodic Future Thinking Effect (Delay Discounting)
time frame: 12-Week Treatment Interval
description: Treatment-related change in the difference in delay discounting slopes (ln(k)) estimated for discounting conditions with and without personally meaningful event tags.
measure: Pre- to Post-Treatment Change Spontaneous Eyeblink Rate
time frame: 12-Week Treatment Interval
description: Treatment-related change in spontaneous eyeblink rate at rest.
arm group label: Tangible Prize-Based Contingency Management (TangiblePBCM)
arm group type: Experimental
description: For participants assigned to TangiblePBCM, prize draws resulting in one or more small, large, or jumbo wins will result in access to a prize cabinet stocked with small, medium, large, and jumbo financial incentive items. Medium incentive items are included for selection in the event that a patient draws several small prize slips on the same day and are considered equivalent to 4 small prizes. Selection of specific prize items will be informed by patient preference and items will be restocked at least every 2 weeks. The prize cabinet will be open during TangiblePBCM sessions such that prize items are readily visible. Selection of prizes, maintenance of the prize cabinet, and policies regarding prize redemption will follow published guidance on administration of TangiblePBCM within the context of research protocols.
arm group label: Voucher Prize-Based Contingency Management (VoucherPBCM)
arm group type: Experimental
description: For participants assigned to VoucherPBCM, prize draws resulting in one or more small, large, or jumbo wins will be reinforced with VA Canteen vouchers in the specified incentive range (i.e., small, large, or jumbo).
intervention type: Behavioral
intervention name: Prize-Based Contingency Management
description: Participants assigned to Prize-based Contingency
Management (PBCM) conditions will receive PBCM as an adjunct to TAU. PBCM will involve twice weekly one-on-one sessions with a provider for 12-weeks. During each session, a urine specimen provided by the patient will be tested for cocaine using a point-of-care dip-test. Results of point-of-care testing will be shared with the patient and negative results will be reinforced with draws from a fish bowl containing 500 paper slips, 250 of which award small, large, or jumbo prizes (remaining slips deliver words of encouragement). Patients will be reinforced with a single prize draw for their first negative specimen; an additional prize draw will be added for each consecutive negative result (up to 8
prize draws per session). Abstinence-contingent prize draws will be reset to one upon either a positive test result or unexcused, missed appointment.
arm group label: Tangible Prize-Based Contingency Management (TangiblePBCM)
arm group label: Voucher Prize-Based Contingency Management (VoucherPBCM)
intervention type: Behavioral
intervention name: Treatment As Usual Outpatient Substance Use Treatment
description: All participants will receive treatment as usual outpatient substance use services during the 12-week treatment interval. TAU will specifically entail recommended participation in at least two outpatient group and/or individual psychotherapy encounters per week within the Center for Treatment of Addictive Disorders (CTAD) at VA Pittsburgh Healthcare System. Participants will additionally continue any previously prescribed pharmacotherapy for substance use and/or other mental health conditions, if applicable.
arm group label: Tangible Prize-Based Contingency Management (TangiblePBCM)
arm group label: Voucher Prize-Based Contingency Management (VoucherPBCM)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Sarah E. Forster, PhD
role: Principal Investigator
affiliation: VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
last name: Sarah E Forster, PhD
phone: (412) 360-2365
email: Sarah.Forster2@va.gov
last name: Stuart R Steinhauer, PhD
phone: (412) 360-2397
email: Stuart.Steinhauer@va.gov
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
responsible party type: Sponsor
sharing ipd: No
ipd description: If possible, a de-identified, anonymized dataset will be created and shared. However, specific arrangements for sharing have not yet been made and options for data sharing (for example, the availability of data repositories for electroencephalographic data files), as well as VA policies regarding data sharing may change over the course of the study. A detailed plan for data sharing will be developed and approved upon completion of data collection.