Clinical Trial of Integrated Treatment for Pain and Opioid Dependence

NCT00634803 | Completed Phase 1 Results

• 2 other identifiers: 06080017761R01DA024695-01A2
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Opiate Dependence; Chronic Pain

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

CBT for POD

EXPERIMENTAL

Integrated cognitive behavioral therapy for chronic pain and opioid dependence

Behavioral: CBT; Drug: Buprenorphine

Educational Counseling for POD

ACTIVE COMPARATOR

Educational Counseling is a didactic, lecture-discussion format to supplement the information and advice provided by physicians in physician management (PM)

Drug: Buprenorphine; Other: Educational Counseling

Physician Management

ACTIVE COMPARATOR

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; Other: Physician Management

Interventions

CBT BEHAVIORAL

Cognitive behavioral therapy

CBT for POD

Buprenorphine DRUG

buprenorphine/naloxone

CBT for POD; Educational Counseling for POD; Physician Management

Educational Counseling OTHER

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

Educational Counseling for POD

Physician Management OTHER

Brief physician counseling

Physician Management

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• prescription opioid addiction criteria
• moderate to severe chronic pain
• seeking or interested in buprenorphine maintenance
• understand English

You may not qualify if:

• methadone maintenance at a dose greater than 40 mg daily
• current suicide or homicide risk
• life-threatening or unstable medical problem
• pregnancy

Sponsors & Collaborators

• Yale University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Methadone Research Unit

New Haven, Connecticut, 06519, United States

Location

Related Publications (1)

• 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.

  PMID: 27574837 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders; Chronic Pain

Interventions

Buprenorphine; Practice Management

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Professional Practice; Organization and Administration; Health Services Administration

Results Point of Contact

• Title: Richard S. Schottenfeld, M.D.
• Organization: Yale University

richard.schottenfeld@yale.edu

203-974-7349

Study Officials

• Richard S Schottenfeld, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2008
• First Posted: March 13, 2008
• Study Start: September 1, 2009
• Primary Completion: May 1, 2015
• Study Completion: August 1, 2015
• Last Updated: August 2, 2021
• Results First Posted: September 1, 2020

Record last verified: 2021-07

Locations

US (1)