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):

Declan Barry, Yale University

ClinicalTrials.gov Identifier:

NCT01334580

First received: April 11, 2011

Last updated: January 13, 2014

Last verified: January 2014

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

Drug Information available for: Methadone Methadone hydrochloride

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:	September 2014 (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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:	Declan Barry, Principal Investigator, Yale University
ClinicalTrials.gov Identifier:	NCT01334580 History of Changes
Other Study ID Numbers:	K23 DA024050-03
Study First Received:	April 11, 2011
Last Updated:	January 13, 2014
Health Authority:	United States: Federal Government United States: Institutional Review Board

Additional relevant MeSH terms:


Chronic Pain Nervous System Diseases Neurologic Manifestations Pain Signs and Symptoms Methadone Analgesics Analgesics, Opioid Antitussive Agents	Central Nervous System Agents Central Nervous System Depressants Narcotics Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Respiratory System Agents Sensory System Agents Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015

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