Cognitive-Behavioral Therapy for Pain and Opioid Dependence in Methadone Maintenance Treatment
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| ClinicalTrials.gov Identifier: NCT01334580 |
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Recruitment Status :
Completed
First Posted : April 13, 2011
Last Update Posted : June 29, 2016
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Sponsor:
Yale University
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Declan Barry, Yale University
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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 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
Genetics Home Reference related topics:
Opioid addiction
MedlinePlus related topics:
Chronic Pain
| Arm | Intervention/treatment |
|---|---|
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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
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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. |
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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.
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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. |
Primary Outcome Measures :
- Pain reduction [ Time Frame: 16 weeks ]
- Reduce illicit opioid use [ Time Frame: 16 weeks ]
Secondary Outcome Measures :
- Finalization of treatment manuals [ Time Frame: 16 weeks ]
- Development and modification of therapy training and process rating measures [ Time Frame: 16 weeks ]
Information from the National Library of Medicine
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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
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
| 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 |
| Responsible Party: | Declan Barry, Principal Investigator, Yale University |
| ClinicalTrials.gov Identifier: | NCT01334580 History of Changes |
| Other Study ID Numbers: |
K23DA024050-03 ( U.S. NIH Grant/Contract ) |
| First Posted: | April 13, 2011 Key Record Dates |
| Last Update Posted: | June 29, 2016 |
| Last Verified: | June 2016 |
Additional relevant MeSH terms:
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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 |