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Completed

NCT Number: NCT01334580

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Methadone Research Unit

New Haven, Connecticut, 06519, United States

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 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

Treatment and study plan

Cognitive-Behavioral Therapy for Pain and Opioid Dependence

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Pain reduction

    Time frame: 16 weeks

  2. Reduce illicit opioid use

    Time frame: 16 weeks

Secondary outcomes

  1. Finalization of treatment manuals

    Time frame: 16 weeks

  2. Development and modification of therapy training and process rating measures

    Time frame: 16 weeks

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Apr 13, 2011
Registry last updated
Apr 3, 2020

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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