Opioid Use Disorder
Conditions
Brief summary
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
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.
Interventions
BEHAVIORAL12 Week Manualized Cognitive-Behavioral Therapy Intervention
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.
Sponsors
Prevention Point Philadelphia
Philadelphia College of Osteopathic Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urinalysis-confirmed Reduction or Elimination of Illicit Opioid Use | Baseline, 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Patient Health Questionnaire-9 (PHQ-9) | Baseline, 12 weeks | 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. The PHQ-9 is scored on a 4-point Likert-type scale, with the lowest value being Not at All and the highest value being Nearly Every Day with higher overall scores indicating more severe depression. |
| The Brief Assessment of Recovery Capital (BARC-10) | Baseline, 12 weeks | 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). The BARC-10 is scored on a 6-point Likert-type scale ranging from Strongly Disagree to Strongly Agree with higher scores indicating higher recovery capital. |
| The Client Satisfaction Questionnaire-8 (CSQ-8) | 12 weeks | The CSQ-8 is a brief, eight-item treatment satisfaction questionnaire. The CSQ-8 is scored on a series of 4-point Likert-type scales, with higher scores indicating greater treatment satisfaction. |
Countries
United States
Outcome results
None listed