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NCT01334580 Clinical Trial

Cognitive-Behavioral Therapy for Pain and Opioid Dependence in Methadone Maintenance Treatment

Chronic Pain Clinical Trial

Official title:
Comparison of Cognitive-Behavioral Therapy and Methadone Drug Counseling for Methadone-Maintained Patients With Co-occurring Chronic Pain and Opioid Dependence

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01334580
Other study ID # 0703002496_B
Secondary ID K23DA024050-03
Status Completed
Phase Phase 1
First received
Last updated
Start date April 2011
Est. completion date September 2014

Study information
Verified date April 2020
Source Yale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study involves the comparison of two treatment approaches for patients with chronic pain who are entering methadone maintenance treatment (MMT) for opioid addiction: (a) an integrated counseling that addresses both chronic pain and opioid dependence(POD)and (b) a counseling intervention that addresses opioid dependence only.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date September 2014
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 18 years of age or older

- prescription opioid or heroin addiction

- moderate to severe chronic pain

- enrolled in methadone maintenance at the APT Foundation for opioid addiction

- understand English

Exclusion Criteria:

- current suicide or homicide risk

- life-threatening or unstable medical problem

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Cognitive-Behavioral Therapy for Pain and Opioid Dependence
CBT is provided by skilled psychologists in weekly sessions for 12 weeks and focuses on reducing illicit drug use and increasing pain management.
• Methadone Drug Counseling
Methadone Drug Counseling (MDC)is provided by skilled drug counselors over a 12-week period. The primary goal of MDC is cessation of illicit drugs.

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 reduction 16 weeks
Primary Reduce illicit opioid use 16 weeks
Secondary Finalization of treatment manuals 16 weeks
Secondary Development and modification of therapy training and process rating measures 16 weeks
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