NCT00634803

Clinical Trial of Integrated Treatment for Pain and Opioid Dependence

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	CBT	Cognitive behavioral therapy
DRUG	Buprenorphine	buprenorphine/naloxone
OTHER	Educational Counseling	Didactic, lecture-discussion format to supplement information and advice provided by physicians
OTHER	Physician Management	Brief physician counseling

Timeline

• Start date: 2009-09-01
• Primary completion: 2015-05-01
• Completion: 2015-08-01
• First posted: 2008-03-13
• Last updated: 2021-08-02
• Results posted: 2020-09-01

Locations

1 site across 1 country: United States