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Sponsors and Collaborators: |
National Institute on Drug Abuse (NIDA) New York State Psychiatric Institute |
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Information provided by: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00238914 |
The overall goal of this research project is to test a newly developed behavioral therapy to enhance the efficacy of naltrexone maintenance and make it a viable alternative to methadone maintenance or detoxification methods for treatment of opiate dependence. HYPOTHESES:
Condition | Intervention | Phase |
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Heroin Dependence |
Drug: Naltrexone |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study |
Official Title: | Opiate Dependence: Combined Naltrexone/Behavior Therapy |
Enrollment: | 12 |
Study Start Date: | August 1999 |
Study Completion Date: | July 2002 |
Primary Completion Date: | July 2002 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Compliance enhancement plus oral naltrexone
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Drug: Naltrexone
50mg of oral naltrexone daily
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2: Active Comparator
Behavioral naltrexone therapy plus oral naltrexone
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Drug: Naltrexone
50mg of oral naltrexone daily
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Long-term maintenance on naltrexone has proven efficacy as a treatment for opiate dependence, but has not been successful clinically because of at least three problems: 1) The transition from opiate to naltrexone precipitates opiate withdrawal unless the patient has been off any opiates for at least seven days; 2) Compliance issues: patients can miss a few naltrexone doses and begin to experience effects from illicit opiates and become re-addicted, at which point naltrexone cannot be restarted without precipitating withdrawal; 3) Naltrexone may produce dysphoria in some patients. The proposed research study wilL offer opiate dependent patients brief hospitalization for a rapid detoxification from opiate to naltrexone, using buprenorphine, clonidine and clonazepam. If the patient has already undergone detoxification at an outside unit, they will be assessed for opiate dependence using the naloxone challenge. Patients will then be either discharged or entered directly into outpatient treatment where they will be randomly assigned to either the newly developed "Behavioral Naltrexone Therapy" (BNT), a hybrid of Relapse Prevention, the Community Reinforcement Approach, and Network Therapy or to Compliance Enhancement (CE) therapy, a controlled therapy intended to simulate outpatient psychiatric care. BNT employs behavioral incentives and enlists members of the family and social network to reinforce naltrexone compliance and abstinence. In this current investigation, for both BNT and CE, all patients are maintained on oral naltrexone. Patients are stratified at baseline by presence or absence of lifetime depressive disorder, which we hypothesize will predict dysphoria on naltrexone and non-compliance. Patients are discharged from the hospital, or entered directly, into outpatient treatment at STARS at NYSPI to receive both counseling and Naltrexone, 50 mg per day.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion:
Exclusion:
United States, New York | |
New York State Psychiatric Institute | |
New York, New York, United States, 10032 |
Principal Investigator: | Edward Nunes, M.D. | New York State Psychiatric Institute |
Responsible Party: | Columbia University/NYSPI ( Edward Nunes, MD ) |
Study ID Numbers: | NIDA-10746-1, R01-10746-1 |
Study First Received: | October 13, 2005 |
Last Updated: | July 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00238914 History of Changes |
Health Authority: | United States: Federal Government; United States: Food and Drug Administration |
Mental Disorders Heroin Dependence Narcotic Antagonists Naltrexone Substance-Related Disorders |
Disorders of Environmental Origin Narcotics Peripheral Nervous System Agents Opioid-Related Disorders |
Heroin Dependence Narcotic Antagonists Physiological Effects of Drugs Disorders of Environmental Origin Opioid-Related Disorders Pharmacologic Actions Mental Disorders |
Sensory System Agents Therapeutic Uses Naltrexone Substance-Related Disorders Peripheral Nervous System Agents Central Nervous System Agents |