Clinical Trial of Integrated Treatment for Pain and Opioid Dependence

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

Detailed Description
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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: 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. 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.

Official Title
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Clinical Trial of Integrated Treatment for Pain and Opioid Dependence

Conditions
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Opiate Dependence, Chronic Pain

Intervention / Treatment
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* Behavioral: CBT
* Drug: Buprenorphine
* Other: Educational Counseling
* Other: Physician Management


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBT for POD<br>Integrated cognitive behavioral therapy for chronic pain and opioid dependence | Behavioral: CBT<br>* Cognitive behavioral therapy<br>Drug: Buprenorphine<br>* buprenorphine/naloxone<br>|
| Active Comparator: Educational Counseling for POD<br>Educational Counseling is a didactic, lecture-discussion format to supplement the information and advice provided by physicians in physician management (PM) | Drug: Buprenorphine<br>* buprenorphine/naloxone<br>Other: Educational Counseling<br>* Didactic, lecture-discussion format to supplement information and advice provided by physicians<br>|
| Active Comparator: Physician Management<br>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<br>* buprenorphine/naloxone<br>Other: Physician Management<br>* Brief physician counseling<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Intensity | 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 | 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 | 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 |