Clinical Trial of Integrated Treatment for Pain and Opioid Dependence

Phase 1

Completed

Conditions: Opiate Dependence
Chronic Pain

Interventions: Behavioral: CBT
Drug: Buprenorphine
Other: Educational Counseling
Other: Physician Management

Registration Number: NCT00634803

Lead Sponsor: Yale University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 90

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CBT for POD	CBT	Integrated cognitive behavioral therapy for chronic pain and opioid dependence
Educational Counseling for POD	Educational Counseling	Educational Counseling is a didactic, lecture-discussion format to supplement the information and advice provided by physicians in physician management (PM)
Physician Management	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.
Physician Management	Buprenorphine	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.
CBT for POD	Buprenorphine	Integrated cognitive behavioral therapy for chronic pain and opioid dependence
Educational Counseling for POD	Buprenorphine	Educational Counseling is a didactic, lecture-discussion format to supplement the information and advice provided by physicians in physician management (PM)

Primary Outcome Measures

Name	Time	Method
Pain Intensity	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.
Pain Interference	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.
Number of Opioid-negative Urine Toxicology Tests	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.