Clinical trial NCT06008769: Therapy for People With Opioid Use Disorder
Official title: Cognitive-Behavioral Therapy for Opioid Use Disorder: A Manualized Pilot Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Opioid Use Disorder
Lead sponsor: Philadelphia College of Osteopathic Medicine
Sponsor class: OTHER
Collaborators: name: Prevention Point Philadelphia
First posted: 2023-08-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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")

Primary outcomes:
measure: Urinalysis-confirmed Reduction or Elimination of Illicit Opioid Use
timeFrame: Baseline, 12 weeks
Secondary outcomes:
measure: The Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline, 12 weeks
measure: The Brief Assessment of Recovery Capital (BARC-10)
timeFrame: Baseline, 12 weeks
measure: The Client Satisfaction Questionnaire-8 (CSQ-8)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Prevention Point Philadelphia
state: Pennsylvania
Study officials:
affiliation: Philadelphia College of Osteopathic Medicine
name: Michelle R Lent, PhD
role: PRINCIPAL_INVESTIGATOR
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