Clinical Trial of Integrated Treatment for Pain and Opioid Dependence (POD)

July 29, 2021 updated by: Yale University
This study is designed to develop an effective psychotherapy for chronic pain and opioid dependence.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study aims to develop a novel manualized intervention using tailored cognitive-behavioral treatment (CBT) and buprenorphine medication to effectively treat the co-occurring disorders of non-malignant pain and opioid dependence (POD).

Specific Aims:

  1. To conduct a pre-pilot phase with 16 patients with POD receiving buprenorphine maintenance treatment (BMT). In the pre-pilot phase, we will also explore the effects of different daily buprenorphine dosages on pain and opiate use.
  2. To conduct a pilot randomized, clinical trial to obtain data regarding the feasibility, acceptability and efficacy (compared to Physician Management(PM) only) of manual-guided CBT or Educational Counseling (EC) for patients with POD treated with BMT (N=75).

The secondary outcomes: Development of a Treatment Manual and Development and Modification of Initial Therapy Training and Process Rating Measures were process measures and not been to be included as measures associated with RCT. These outcomes were removed when the RCT results were entered. In addition, outcomes were renamed for clarification.

At results entry, the timeframe (16 weeks) was also corrected to account for the actual timeframe used for analysis in the study. The 16-week study period listed in the protocol included a 2-week buprenorphine induction period (before randomization) and up to a 2-week post-conclusion of the clinical trial continuation on buprenorphine and referral to continuing treatment. In prior studies with buprenorphine, the study team had observed an artificially high attrition during the last 2 weeks of the planned study protocol, when participants were attempting to transition to available clinical treatments outside of the study. Consequently, as per the original study protocol for this study, the plan was to analyze intake and induction data (as baseline data) and then the data from the first 12-weeks post-randomization.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 2
  • Phase 1

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
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Methadone Research Unit

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years of age or older
  • prescription opioid addiction criteria
  • moderate to severe chronic pain
  • seeking or interested in buprenorphine maintenance
  • understand English

Exclusion Criteria:

  • methadone maintenance at a dose greater than 40 mg daily
  • current suicide or homicide risk
  • life-threatening or unstable medical problem
  • pregnancy

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CBT for POD
Integrated cognitive behavioral therapy for chronic pain and opioid dependence
Behavioral: CBT
Cognitive behavioral therapy
Drug: Buprenorphine
buprenorphine/naloxone
Active Comparator: Educational Counseling for POD
Educational Counseling is a didactic, lecture-discussion format to supplement the information and advice provided by physicians in physician management (PM)
Drug: Buprenorphine
buprenorphine/naloxone
Other: Educational Counseling
Didactic, lecture-discussion format to supplement information and advice provided by physicians
Active Comparator: Physician Management
PM is a relatively brief intervention that approximates the medically focused advice and brief counseling about medical issues that is typically provided by physicians to patients with chronic pain or other chronic medical conditions, such as diabetes or asthma.
Drug: Buprenorphine
buprenorphine/naloxone
Other: Physician Management
Brief physician counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Intensity
Time Frame: 3 months
Pain intensity comprises the average of 4 items related to current pain and past-week average pain, pain at its worst, and pain at its least. Pain intensity is scored on 0-10 scale (average score ranges from 0-10), where higher scores indicate higher pain intensity.Originally labeled as Pain Reduction at 16 weeks- 3 months was the correct timeframe.
3 months
Number of Opioid-negative Urine Toxicology Tests
Time Frame: 3 Months
Reduced illicit opioid use is defined as the number of documented opioid negative urine tests in each of the time periods.This measures the reduction in illicit opioid use - more opioid-negative tests means greater reductions in illicit opioid use. The highest possible score is 4- which would indicate 4 negative urine tests during the assessment period. Originally titled "Reduced illicit opioid use" and the timeframe was listed as 16 weeks.
3 Months
Pain Interference
Time Frame: 3 Months
Pain interference comprises the average of 7 items related to past-week pain-related interference in general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. Each item is scored on a 0-10 scale (averaged 0-10), where higher scores indicate higher pain interference.
3 Months

Collaborators and Investigators

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

Sponsor

Yale University

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Richard S Schottenfeld, MD, Yale University

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

September 1, 2009

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

January 2, 2008

First Submitted That Met QC Criteria

March 6, 2008

First Posted (Estimate)

March 13, 2008

Study Record Updates

Last Update Posted (Actual)

August 2, 2021

Last Update Submitted That Met QC Criteria

July 29, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0608001776
  • 1R01DA024695-01A2 (U.S. NIH Grant/Contract)

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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