Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Yale University |
---|---|
Information provided by: | Yale University |
ClinicalTrials.gov Identifier: | NCT00675532 |
In opioid dependent patients treated with long-acting injectable naltrexone (Vivitrol ®), we will compare the efficacy of a primary care model of counseling (Condition 1) versus individualized cognitive-behavioral psychotherapy (Condition 2) for the treatment of opioid dependence. Treatment will last 12 weeks, and participants will be given 380mg of naltrexone per injection (3 injections in total; each lasting 4 weeks).
Primary outcomes will be 1) percent of opioid negative urines and 2) treatment compliance as measured by attendance and time in treatment. Secondary outcomes are opiate craving, opiate withdrawal symptoms, perceived stress scores, severity of addiction problems, and patient satisfaction. Findings will elucidate whether injectable, long-acting naltrexone would be safe and effective in a primary care setting where medication would be administered in the absence of traditional cognitive-behavioral psychotherapy and indicate whether cognitive-behavioral psychotherapy adds to treatment effects above and beyond primary care counseling. If positive, this small controlled study will provide effect size estimates for a larger trial to assess Vivitrol ® in a primary care setting.
Condition | Intervention |
---|---|
Drug Dependence |
Behavioral: Primary Care Counseling Behavioral: Cognitive-behavioral psychotherapy |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | Testing a Primary Care Model for the Treatment of Opioid Dependence Using Long-Acting Injectable Naltrexone (Vivitrol). |
Estimated Enrollment: | 60 |
Study Start Date: | May 2009 |
Estimated Study Completion Date: | August 2011 |
Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Primary Care Counseling
|
Behavioral: Primary Care Counseling
Subjects in this condition will attend bi-weekly 15 minute sessions with the study nurse for primary care counseling which is a brief manual-guided, medically focused counseling approach to the treatment of opioid dependent individuals seen in primary care settings. The brief counseling sessions involve repeated support for and monitoring of medication compliance, and the provision of advice regarding established methods for coping with psychological and social factors that lead to drug use.
|
2: Experimental
Cognitive-behavioral psychotherapy
|
Behavioral: Cognitive-behavioral psychotherapy
Subjects in the CBT condition will participate in bi-weekly 50-minute-long individualized cognitive-behavioral psychotherapy sessions with a CBT trained clinician. The general purpose of the therapy is to: (1) acquire information about important concepts and aspects of recovery from opioid addiction; (2) increase self-awareness of specific problems and issues in relation to addiction and recovery, and (3) learn new coping skills to deal with problems contributing to or resulting from the addiction and to improve overall psychosocial functioning. The primary focus of this approach is to provide patients with frequent supportive contact and to teach cognitive-behavioral relapse prevention skills. |
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Scott M. Hyman, Ph.D. | 203 974-5736 | scott.hyman@yale.edu |
Contact: David Fiellin, MD | (203) 688-2984 | david.fiellin@yale.edu |
United States, Connecticut | |
Yale New Haven Hospital Primary Care Center | |
New Haven, Connecticut, United States, 06519 |
Principal Investigator: | David Fiellin, Ph.D. | Yale School of Medicine |
Responsible Party: | Yale University School of Medicine ( David Fiellin, MD Associate Professor of Medicine ) |
Study ID Numbers: | Yale HIC #0708002942 |
Study First Received: | May 7, 2008 |
Last Updated: | January 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00675532 History of Changes |
Health Authority: | United States: Institutional Review Board; United States: Federal Government |
Opioids, vivitrol, naltrexone, primary care |
Mental Disorders Narcotic Antagonists Naltrexone Substance-Related Disorders Central Nervous System Depressants |
Disorders of Environmental Origin Narcotics Peripheral Nervous System Agents Analgesics Analgesics, Opioid |
Narcotic Antagonists Physiological Effects of Drugs Central Nervous System Depressants Disorders of Environmental Origin Pharmacologic Actions Mental Disorders Sensory System Agents |
Therapeutic Uses Naltrexone Substance-Related Disorders Peripheral Nervous System Agents Analgesics Central Nervous System Agents Analgesics, Opioid |