<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/NCT01693978</url>
  </required_header>
  <id_info>
    <org_study_id>1R34DA032689-01A1</org_study_id>
    <nct_id>NCT01693978</nct_id>
  </id_info>
  <brief_title>Contingency Outcomes in Prolonged Exposure</brief_title>
  <acronym>COPE</acronym>
  <official_title>Incentivizing Adherence to Prolonged Exposure With Substance Users</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johns Hopkins University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this research is to assess whether Contingency Management is effective in&#xD;
      improving treatment adherence in substance use disordered (SUD) patients with comorbid PTSD.&#xD;
      Although Prolonged Exposure therapy (PE) is the gold standard treatment for PTSD, the few&#xD;
      studies of this treatment in substance users have shown poor adherence. Contingency&#xD;
      Management is a well-established approach that could be used to enhance adherence to PE. From&#xD;
      a consented sample of 125 opioid-dependent and methadone-treated patients at Addiction&#xD;
      Treatment Services, an intent-to-treat sample of 62 patients with co-occurring current PTSD&#xD;
      will be offered PE. Half of the 62 participants will be randomly assigned to a Prolonged&#xD;
      Exposure with Contingency Management (PE+CM) condition that provides monetary-based&#xD;
      incentives for attending the PE therapy sessions. The comparison condition will be assigned&#xD;
      to a Prolonged Exposure (PE) condition without the attendance incentives intervention. The PE&#xD;
      sessions will be scheduled once per week for 12 weeks, with a 12-week follow-up. Groups will&#xD;
      be compared primarily on adherence to the PE schedule, improvement in PTSD symptoms, and&#xD;
      rates of drug use (urine specimens, self-reported use). The study's three primary aims are to&#xD;
      1) Evaluate the efficacy of adding voucher-based attendance incentives to PE for PTSD to&#xD;
      increase adherence in SUD patients in a methadone treatment program; 2) Evaluate the efficacy&#xD;
      of adding voucher-based attendance incentives to PE for PTSD to reduce PTSD symptoms in SUD&#xD;
      patients; and 3) Evaluate the effect of PE for PTSD on rates of drug use in SUD patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Prolonged Exposure session attendance</measure>
    <time_frame>12 weeks</time_frame>
    <description>PE session attendance will be measured as the percent of participants completing a full course of PE and as a repeating dichotomous variable (weekly assessments of attended vs. unattended sessions).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PTSD symptoms</measure>
    <time_frame>24 weeks</time_frame>
    <description>Groups will be compared on PTSD symptoms (as measured by CAPS scores) collected at each assessment timepoint (baseline, week 6, week 12, week 24)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Drug use</measure>
    <time_frame>12 weeks</time_frame>
    <description>Groups will be compared on weekly drug test results (presence/absence of drug) and on self-reported number of days using each drug during the 12-week treatment phase.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">126</enrollment>
  <condition>Posttraumatic Stress Disorder</condition>
  <condition>Substance Use Disorder</condition>
  <arm_group>
    <arm_group_label>Reinforced Prolonged Exposure (RPE)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants will be scheduled to attend a weekly Prolonged Exposure therapy session for 12 consecutive weeks, and followed for 12 additional weeks. RPE participants will receive voucher-based reinforcement contingent on attendance to scheduled Prolonged Exposure therapy sessions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Prolonged Exposure (SPE)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>All participants will be scheduled to attend a weekly Prolonged Exposure therapy session for 12 consecutive weeks, and followed for 12 additional weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Prolonged Exposure Therapy</intervention_name>
    <description>Prolonged Exposure Therapy is considered the &quot;gold standard&quot; treatment for PTSD in psychiatry. It uses a cognitive-behavioral approach that repeatedly and systematically exposes patients to memories of their traumatic events to reduce fear and arousal. The PE therapy offered in this study will be based on procedures used by Foa and colleagues, described in their book-length treatment manual (Foa, Hembree, &amp; Rothbaum, 2007).</description>
    <arm_group_label>Reinforced Prolonged Exposure (RPE)</arm_group_label>
    <arm_group_label>Standard Prolonged Exposure (SPE)</arm_group_label>
    <other_name>PE Therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Voucher-Based Reinforcement</intervention_name>
    <description>Those in the PE+CM condition will also be able to earn voucher-based incentives for each therapy session that they attend as scheduled, with a maximum of $480 for full adherence to all sessions. Specifically, participants will earn $30 for attending Session 1, $40 for attending Session 2, $50 for attending Session 3, and $60 for attending Sessions 4 through 9. There will be no payment for Sessions 10 through 12. Because it is very important that participants attend sessions on schedule, voucher values will be reset starting from $30 if participants miss a scheduled session. Vouchers can be exchanged for goods and services in the community (e.g., gift cards to local retailers).</description>
    <arm_group_label>Reinforced Prolonged Exposure (RPE)</arm_group_label>
    <other_name>Vouchers</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria for Phase I (evaluation):&#xD;
&#xD;
          -  positive screen for PTSD, as determined by score on the MPSS-R&#xD;
&#xD;
          -  methadone maintenance for at least 4 weeks (to help ensure initial stabilization on&#xD;
             methadone)&#xD;
&#xD;
          -  at least 18 years of age&#xD;
&#xD;
        Inclusion criteria for Phase 2 (treatment):&#xD;
&#xD;
          -  confirmation of current PTSD based on the Clinician-Administered PTSD Scale&#xD;
&#xD;
          -  no psychiatric contraindications to PE (e.g., current suicidal/homicidal intent)&#xD;
&#xD;
          -  clear memory for the traumatic event (e.g., flashbacks or re-experiencing the event)&#xD;
&#xD;
          -  interest in receiving PE&#xD;
&#xD;
          -  agree to sign release of information for any current psychiatric treatment providers&#xD;
             outside of ATS&#xD;
&#xD;
          -  agree to delay taking daily methadone dose on exposure therapy days until after&#xD;
             session&#xD;
&#xD;
          -  no history of prior exposure-based therapy for PTSD&#xD;
&#xD;
          -  agree to audiotaping of therapy sessions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  acute medical problem that requires immediate and intense medical management (e.g.,&#xD;
             AIDS defining illness; active tuberculosis)&#xD;
&#xD;
          -  presence of a formal thought disorder, delusions, hallucinations, or imminent risk of&#xD;
             harm to self or others&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jessica Peirce, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Addiction Treatment Services</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>September 21, 2012</study_first_submitted>
  <study_first_submitted_qc>September 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2012</study_first_posted>
  <last_update_submitted>August 30, 2016</last_update_submitted>
  <last_update_submitted_qc>August 30, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 31, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Johns Hopkins University</investigator_affiliation>
    <investigator_full_name>Jessica Peirce</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>PTSD</keyword>
  <keyword>Prolonged Exposure</keyword>
  <keyword>Comorbidity</keyword>
  <keyword>Treatment</keyword>
  <keyword>Methadone Maintenance</keyword>
  <keyword>Substance Use Disorder</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Substance-Related Disorders</mesh_term>
    <mesh_term>Stress Disorders, Post-Traumatic</mesh_term>
  </condition_browse>
  <!-- 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/NCT01693978
org study id: 1R34DA032689-01A1
nct id: NCT01693978
lead sponsor: 
has dmc: No
The aim of this research is to assess whether Contingency Management is effective in
      improving treatment adherence in substance use disordered (SUD) patients with comorbid PTSD.
      Although Prolonged Exposure therapy (PE) is the gold standard treatment for PTSD, the few
      studies of this treatment in substance users have shown poor adherence. Contingency
      Management is a well-established approach that could be used to enhance adherence to PE. From
      a consented sample of 125 opioid-dependent and methadone-treated patients at Addiction
      Treatment Services, an intent-to-treat sample of 62 patients with co-occurring current PTSD
      will be offered PE. Half of the 62 participants will be randomly assigned to a Prolonged
      Exposure with Contingency Management (PE+CM) condition that provides monetary-based
      incentives for attending the PE therapy sessions. The comparison condition will be assigned
      to a Prolonged Exposure (PE) condition without the attendance incentives intervention. The PE
      sessions will be scheduled once per week for 12 weeks, with a 12-week follow-up. Groups will
      be compared primarily on adherence to the PE schedule, improvement in PTSD symptoms, and
      rates of drug use (urine specimens, self-reported use). The study's three primary aims are to
      1) Evaluate the efficacy of adding voucher-based attendance incentives to PE for PTSD to
      increase adherence in SUD patients in a methadone treatment program; 2) Evaluate the efficacy
      of adding voucher-based attendance incentives to PE for PTSD to reduce PTSD symptoms in SUD
      patients; and 3) Evaluate the effect of PE for PTSD on rates of drug use in SUD patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Prolonged Exposure session attendance
time frame: 12 weeks
description: PE session attendance will be measured as the percent of participants completing a full course of PE and as a repeating dichotomous variable (weekly assessments of attended vs. unattended sessions).
measure: PTSD symptoms
time frame: 24 weeks
description: Groups will be compared on PTSD symptoms (as measured by CAPS scores) collected at each assessment timepoint (baseline, week 6, week 12, week 24)
measure: Drug use
time frame: 12 weeks
description: Groups will be compared on weekly drug test results (presence/absence of drug) and on self-reported number of days using each drug during the 12-week treatment phase.
arm group label: Reinforced Prolonged Exposure (RPE)
arm group type: Experimental
description: All participants will be scheduled to attend a weekly Prolonged Exposure therapy session for 12 consecutive weeks, and followed for 12 additional weeks. RPE participants will receive voucher-based reinforcement contingent on attendance to scheduled Prolonged Exposure therapy sessions.
arm group label: Standard Prolonged Exposure (SPE)
arm group type: Active Comparator
description: All participants will be scheduled to attend a weekly Prolonged Exposure therapy session for 12 consecutive weeks, and followed for 12 additional weeks.
intervention type: Behavioral
intervention name: Prolonged Exposure Therapy
description: Prolonged Exposure Therapy is considered the "gold standard" treatment for PTSD in psychiatry. It uses a cognitive-behavioral approach that repeatedly and systematically exposes patients to memories of their traumatic events to reduce fear and arousal. The PE therapy offered in this study will be based on procedures used by Foa and colleagues, described in their book-length treatment manual (Foa, Hembree, & Rothbaum, 2007).
arm group label: Reinforced Prolonged Exposure (RPE)
arm group label: Standard Prolonged Exposure (SPE)
other name: PE Therapy
intervention type: Behavioral
intervention name: Voucher-Based Reinforcement
description: Those in the PE+CM condition will also be able to earn voucher-based incentives for each therapy session that they attend as scheduled, with a maximum of $480 for full adherence to all sessions. Specifically, participants will earn $30 for attending Session 1, $40 for attending Session 2, $50 for attending Session 3, and $60 for attending Sessions 4 through 9. There will be no payment for Sessions 10 through 12. Because it is very important that participants attend sessions on schedule, voucher values will be reset starting from $30 if participants miss a scheduled session. Vouchers can be exchanged for goods and services in the community (e.g., gift cards to local retailers).
arm group label: Reinforced Prolonged Exposure (RPE)
other name: Vouchers
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Jessica Peirce, Ph.D.
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Johns Hopkins University
investigator full name: Jessica Peirce
investigator title: Assistant Professor
mesh term: Substance-Related Disorders
mesh term: Stress Disorders, Post-Traumatic