Cognitive-Behavioral Therapy for Opioid Use Disorder: A Manualized Pilot Study

Study Overview
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Brief Summary
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The goal of this pilot clinical trial is to test the feasibility of a 12-week manualized cognitive-behavioral therapy treatment for opioid use disorder in reducing or stopping illicit opioid use in a community setting. Participants will complete 12 weeks of therapy with a behavioral health counselor and will complete assessments at baseline and 12 weeks. Other outcomes include changes in mood and perceptions of recovery-related support after 12 weeks of therapy.

Detailed Description
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Cognitive-Behavioral Therapy (CBT) is one of the most well-supported and widely used psychosocial treatments for substance use disorders (SUDs); however, few studies have evaluated the efficacy of CBT for opioid use disorder (OUD). This prospective, longitudinal pilot study (pre-post design) will assess the feasibility of the first manualized CBT treatment for OUD in adults (N = 20) in a community-based setting (Prevention Point Philadelphia). This study will utilize clinical (urinalysis), patient-reported, and provider-reported outcomes (mood, support, feasibility, satisfaction with treatment) over 12 weeks of a manualized cognitive-behavioral treatment for OUD. This prospective, longitudinal pilot study will evaluate the feasibility of a novel psychotherapy for OUD. This study will utilize both clinical (urinalysis) and patient or provider-reported (mood, support, feasibility) outcomes to assess the feasibility of 12 weeks of manualized cognitive-behavioral treatment for OUD. All study recruitment, consent and intervention delivery will occur at Prevention Point (2913-15 Kensington Ave, Philadelphia, PA). Outcomes will include participant-reported treatment satisfaction, as well as EMR-extracted clinical data (session attendance, urinalysis, mood, demographics, medical information, and recovery-related support). We hypothesize that individuals with OUD will demonstrate a reduction illicit opioid use from baseline to week 12 as assessed by urinalysis (% change, positive/negative). As a secondary outcome, use of other substances will also be assessed from baseline to week 12 (e.g., alcohol, cocaine). Use of medication for OUD (MOUD; e.g., buprenorphine. methadone) will be accounted for in analyses. We hypothesize that mood and perceptions of recovery-related resources will improve from baseline to week 12. As an exploratory aim, we will evaluate intervention feasibility through electronic medical record (EMR) data of number of sessions attended over 12 weeks, treatment fidelity checklists, and a participant survey of treatment satisfaction.

Official Title
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Cognitive-Behavioral Therapy for Opioid Use Disorder: A Manualized Pilot Study

Conditions
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Opioid Use Disorder

Intervention / Treatment
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* Behavioral: 12 Week Manualized Cognitive-Behavioral Therapy Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient at Prevention Point Philadelphia 18 years or older Living with opioid use disorder Has a goal to reduce or eliminate illicit opioid use Able to provide informed consent Exclusion Criteria: Not comfortable receiving psychotherapy in English Under custodial supervision through the legal justice system (e.g., halfway house following incarceration, involuntary detention or confinement, status as a prisoner)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 12 Week Manualized Cognitive-Behavioral Therapy Intervention<br>Participants will receive a once-per-week, 12 week manualized cognitive-behavioral therapy intervention. | Behavioral: 12 Week Manualized Cognitive-Behavioral Therapy Intervention<br>* The manualized intervention, Cognitive Behavioral Therapy for Opioid Use Disorder, was co-written and developed by the study PI, Dr. Lent (see Appendix). The manual consists of one module (Module 0) on assessment and 12 modules of CBT. This study will focus on delivery of Modules 1-12 that focus on several tenets of CBT, including skill development (cognitive restructuring, refusal skills, problem-solving, coping strategies), functional analysis (triggers, reinforcement) and utilizing the cognitive model.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinalysis-confirmed Reduction or Elimination of Illicit Opioid Use |  | Baseline, 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Patient Health Questionnaire-9 (PHQ-9) | The PHQ-9 is a nine-item instrument (0-3 Likert type scale) for monitoring and measuring depression severity over the past two weeks. The PHQ-9 has strong validity and reliability and is frequently used in clinical settings. | Baseline, 12 weeks | 
| The Brief Assessment of Recovery Capital (BARC-10) | The BARC-10 is a 10-item measure assessing the perceived characteristics and assets and individual develops on their recovery journey. The BARC-10 has high internal consistency (α = .90). | Baseline, 12 weeks | 
| The Client Satisfaction Questionnaire-8 (CSQ-8) | The CSQ-8 is a brief, eight-item treatment satisfaction questionnaire. | 12 weeks |