Cognitive-Behavioral Therapy for Pain and Opioid Dependence in Methadone Maintenance Treatment
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01334580 |
Recruitment Status :
Completed
First Posted : April 13, 2011
Last Update Posted : April 3, 2020
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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 |

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
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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. |
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. |
- Pain reduction [ Time Frame: 16 weeks ]
- Reduce illicit opioid use [ Time Frame: 16 weeks ]
- Finalization of treatment manuals [ Time Frame: 16 weeks ]
- Development and modification of therapy training and process rating measures [ Time Frame: 16 weeks ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
United States, Connecticut | |
Methadone Research Unit | |
New Haven, Connecticut, United States, 06519 |
Principal Investigator: | Declan Barry, PhD | Yale University |
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 |
Chronic Pain Opioid-Related Disorders Pain Neurologic Manifestations 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 |