Therapy for People With Opioid Use Disorder

June 21, 2024 updated by: Philadelphia College of Osteopathic Medicine

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19134
        • Prevention Point Philadelphia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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")

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 12 Week Manualized Cognitive-Behavioral Therapy Intervention
Participants will receive a once-per-week, 12 week manualized cognitive-behavioral therapy intervention.
Behavioral: 12 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Patient Health Questionnaire-9 (PHQ-9)
Time Frame: 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.
Baseline, 12 weeks
The Brief Assessment of Recovery Capital (BARC-10)
Time Frame: 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.
Baseline, 12 weeks
The Client Satisfaction Questionnaire-8 (CSQ-8)
Time Frame: 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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Philadelphia College of Osteopathic Medicine

Collaborators

Prevention Point Philadelphia

Investigators

  • Principal Investigator: Michelle R Lent, PhD, Philadelphia College of Osteopathic Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 6, 2023

Primary Completion (Actual)

June 17, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

August 17, 2023

First Submitted That Met QC Criteria

August 17, 2023

First Posted (Actual)

August 24, 2023

Study Record Updates

Last Update Posted (Actual)

June 25, 2024

Last Update Submitted That Met QC Criteria

June 21, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H23-025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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