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

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ClinicalTrials.gov Identifier: NCT01334580
Recruitment Status : Completed
First Posted : April 13, 2011
Last Update Posted : April 3, 2020
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Yale University

Study Description
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Brief 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.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (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
Study Start Date : April 2011
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Pain reduction [ Time Frame: 16 weeks ]
  2. Reduce illicit opioid use [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. Finalization of treatment manuals [ Time Frame: 16 weeks ]
  2. Development and modification of therapy training and process rating measures [ Time Frame: 16 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01334580


Locations
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United States, Connecticut
Methadone Research Unit
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Declan Barry, PhD Yale University
More Information
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01334580    
Other Study ID Numbers: 0703002496_B
K23DA024050-03 ( U.S. NIH Grant/Contract )
First Posted: April 13, 2011    Key Record Dates
Last Update Posted: April 3, 2020
Last Verified: April 2020
Additional relevant MeSH terms:
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Chronic Pain
Opioid-Related Disorders
Pain
Neurologic Manifestations
Narcotic-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Methadone
 Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents