Clinical Trial of Integrated Treatment for Pain and Opioid Dependence

NCT ID: NCT00634803

Last Updated: 2021-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2015-08-31

Brief Summary

This study is designed to develop an effective psychotherapy for chronic pain and opioid dependence.

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.

Conditions

Opiate Dependence; Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CBT for POD

Integrated cognitive behavioral therapy for chronic pain and opioid dependence

Group Type: EXPERIMENTAL

CBT

Intervention Type: BEHAVIORAL

Cognitive behavioral therapy

Buprenorphine

Intervention Type: DRUG

buprenorphine/naloxone

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)

Group Type: ACTIVE_COMPARATOR

Buprenorphine

Intervention Type: DRUG

buprenorphine/naloxone

Educational Counseling

Intervention Type: OTHER

Didactic, lecture-discussion format to supplement information and advice provided by physicians

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.

Group Type: ACTIVE_COMPARATOR

Buprenorphine

Intervention Type: DRUG

buprenorphine/naloxone

Physician Management

Intervention Type: OTHER

Brief physician counseling

Interventions

CBT

Cognitive behavioral therapy

Intervention Type: BEHAVIORAL

Buprenorphine

buprenorphine/naloxone

Intervention Type: DRUG

Educational Counseling

Didactic, lecture-discussion format to supplement information and advice provided by physicians

Intervention Type: OTHER

Physician Management

Brief physician counseling

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard S Schottenfeld, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Methadone Research Unit

New Haven, Connecticut, United States

Countries

United States

References

Barry DT, Cutter CJ, Beitel M, Kerns RD, Liong C, Schottenfeld RS. Psychiatric Disorders Among Patients Seeking Treatment for Co-Occurring Chronic Pain and Opioid Use Disorder. J Clin Psychiatry. 2016 Oct;77(10):1413-1419. doi: 10.4088/JCP.15m09963.

Reference Type: DERIVED

PMID: 27574837 (View on PubMed)

Other Identifiers

1R01DA024695-01A2

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0608001776

Identifier Type: -

Identifier Source: org_study_id