Clinical trial NCT00634803: Clinical Trial of Integrated Treatment for Pain and Opioid Dependence
Official title: Clinical Trial of Integrated Treatment for Pain and Opioid Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Opiate Dependence
Chronic Pain
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2008-03-13
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pain Intensity
timeFrame: 3 months
measure: Number of Opioid-negative Urine Toxicology Tests
timeFrame: 3 Months
measure: Pain Interference
timeFrame: 3 Months
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Methadone Research Unit
state: Connecticut
Study officials:
affiliation: Yale University
name: Richard S Schottenfeld, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.