Clinical Trial of Integrated Treatment for Pain and Opioid Dependence

Chronic Pain Clinical Trial

— POD  

Official title:

Clinical Trial of Integrated Treatment for Pain and Opioid Dependence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00634803
• Other study ID #: 0608001776
• Secondary ID: 1R01DA024695-01A
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: September 2009
• Est. completion date: August 2015

Study information

• Verified date: July 2021
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Opiate Dependence
• Opioid-Related Disorders

Intervention

Behavioral:
• CBT
Cognitive behavioral therapy

Drug:
• Buprenorphine
buprenorphine/naloxone

Other:
• Educational Counseling
Didactic, lecture-discussion format to supplement information and advice provided by physicians
• Physician Management
Brief physician counseling

Locations

Country	Name	City	State
United States	Methadone Research Unit	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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