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Completed

NCT Number: NCT00634803

Clinical Trial of Integrated Treatment for Pain and Opioid Dependence

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

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Key information

Conditions

Opiate Dependence Chemically-Induced Disorders Chronic Pain Mental Disorders Narcotic-Related Disorders Neurologic Manifestations Opioid-Related Disorders Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Methadone Research Unit

New Haven, Connecticut, 06519, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CBT

Behavioral

Cognitive behavioral therapy

buprenorphine

Drug

buprenorphine/naloxone

Educational Counseling

Other

Didactic, lecture-discussion format to supplement information and advice provided by physicians

Physician Management

Other

Brief physician counseling

Primary outcomes

  1. Pain Intensity

    Time frame: 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.

  2. Number of Opioid-negative Urine Toxicology Tests

    Time frame: 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.

  3. Pain Interference

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Acronym: POD

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Mar 13, 2008
Registry last updated
Aug 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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