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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01334580
First received: April 11, 2011
Last updated: May 13, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Chronic Pain
Opiate Dependence
 Behavioral: Cognitive-Behavioral Therapy for Pain and Opioid Dependence
Behavioral: Methadone Drug Counseling
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Cognitive-Behavioral Therapy and Methadone Drug Counseling for Methadone-Maintained Patients With Co-occurring Chronic Pain and Opioid Dependence

Resource links provided by NLM:

MedlinePlus related topics: Chronic Pain
U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:
  • Pain reduction [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Reduce illicit opioid use [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Finalization of treatment manuals [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Development and modification of therapy training and process rating measures [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: April 2011
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Methadone Drug Counseling
Methadone Drug Counseling is provided by skilled drug counselors over a 12 week period and focuses on cessation of illicit drugs
 Behavioral: 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.
Experimental: 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.
 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01334580

Locations
United States, Connecticut
Methadone Research Unit
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Declan Barry, PhD Yale University
  More Information

No publications provided

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01334580     History of Changes
Other Study ID Numbers: K23 DA024050-03
Study First Received: April 11, 2011
Last Updated: May 13, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Mental Disorders
Methadone
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Narcotics

ClinicalTrials.gov processed this record on May 21, 2013