Cognitive-Behavioral Therapy for Pain and Opioid Dependence in Methadone Maintenance Treatment
This study has been completed.
Sponsor:
Yale University
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: June 28, 2016
Last verified: June 2016
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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:
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 ]
| Enrollment: | 40 |
| Study Start Date: | April 2011 |
| Study Completion Date: | September 2014 |
| 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 (Adult, Senior) |
| 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
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
| Responsible Party: | Declan Barry, Principal Investigator, Yale University |
| ClinicalTrials.gov Identifier: | NCT01334580 History of Changes |
| Other Study ID Numbers: | K23DA024050-03 |
| Study First Received: | April 11, 2011 |
| Last Updated: | June 28, 2016 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Chronic Pain Opioid-Related Disorders Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Analgesics, Opioid |
Methadone Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Antitussive Agents Respiratory System Agents |
ClinicalTrials.gov processed this record on September 27, 2016