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

Yale University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Opiate Dependence; Chronic Pain

Treatments: Drug: Buprenorphine; Other: Physician Management; Behavioral: CBT; Other: Educational Counseling

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00634803

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

0608001776

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

CBT for POD

Experimental group

Description:

Integrated cognitive behavioral therapy for chronic pain and opioid dependence

Treatment:

Drug: Buprenorphine

Behavioral: CBT

Educational Counseling for POD

Active Comparator group

Description:

Educational Counseling is a didactic, lecture-discussion format to supplement the information and advice provided by physicians in physician management (PM)

Treatment:

Drug: Buprenorphine

Other: Educational Counseling

Physician Management

Active Comparator group

Description:

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.

Treatment:

Drug: Buprenorphine

Other: Physician Management