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Sponsors and Collaborators: |
National Development and Research Institutes, Inc. St. Luke's-Roosevelt Hospital Center |
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Information provided by: | National Development and Research Institutes, Inc. |
ClinicalTrials.gov Identifier: | NCT00182572 |
The purpose of this study is to evaluate ways to optimize outcomes from combined behavioral-pharmacological treatment for opioid-dependent youth.
Condition | Intervention | Phase |
---|---|---|
Opioid-Dependence Among Adolescents |
Drug: buprenorphine Drug: naltrexone Procedure: behavior therapy Procedure: voucher-based contingency management |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Science-Based Treatment for Opioid-Dependent Adolescents |
Estimated Enrollment: | 80 |
Study Start Date: | July 2005 |
Adolescents are increasingly abusing and becoming dependent on heroin and other opioids. The number of emergency room visits related to heroin among 12-17 year olds rose almost 600%, and the self-reported prevalence of heroin use among this group more than doubled in the last decade. As a result of the increased availability of high-potency, low-cost heroin, many adolescents initiate heroin use by snorting it; however, many often then progress to injection of heroin. Despite the critical need to identify efficacious treatments for this population, virtually no research has been conducted to systematically characterize or evaluate treatment interventions for adolescent heroin and opioid abusers. We recently conducted the first controlled study funded by NIDA to systematically evaluate the efficacy of several pharmacotherapies as detoxification agents along with intensive behavioral interventions in the treatment of this population. The purpose of this study is to evaluate ways to further improve on the promising outcomes from our initial study via combined behavioral-buprenorphine treatment for opioid-dependent youth. The primary aim is to examine if improved treatment outcomes can be achieved if the duration of buprenorphine detoxification is lengthened (when the rate of decrease in buprenorphine dose is slower, withdrawal symptoms may be of reduced intensity and youth are provided with a greater opportunity to learn new skills and behaviors addressing how they might best discontinue their opiate use, prevent relapse, and meet treatment goals). A secondary aim is to examine if the provision of monetary voucher-based incentives contingent on consumption of the opioid antagonist, naltrexone, reduces rates of relapse to opiate use in adolescents post-detoxification compared to when no such incentives are provided.
This analysis may provide critical empirical information regarding how to best prevent relapse to opioid use among opioid-dependent youth. Another secondary aim is to identify significant predictors of treatment outcome.
We will thus conduct an exploratory evaluation of demographic, baseline drug use, psychological and other history variables that may predict successful treatment outcomes. This work may help inform the refinement of treatment interventions for various sub-populations of opioid-dependent youth. Outcome measures will include opiate and other drug abstinence, retention, opiate withdrawal symptoms, HIV risk behavior, family relationships, as well as a variety of other secondary outcome measures. We plan to collect these measures at intake, during treatment and at several post-treatment follow-up timepoints. Overall, this research will contribute new empirical information that will inform the development of effective treatment interventions for the largely unstudied and rapidly expanding population of opioid-dependent youth.
Ages Eligible for Study: | 13 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Lisa Marsch, PhD | 212-636-1253 | marsch@ndri.org |
Contact: Ramon Solhkhah, MD | 212-523-3069 | RSolhkha@chpnet.org |
United States, New York | |
Behavioral Science Research Unit, St. Luke's Hospital | Recruiting |
New York, New York, United States, 10025 | |
Principal Investigator: Lisa Marsch, PhD |
Principal Investigator: | Lisa Marsch, PhD | National Development and Research Institutes, Inc. |
Study ID Numbers: | R01 DA018297 |
Study First Received: | September 10, 2005 |
Last Updated: | August 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00182572 History of Changes |
Health Authority: | United States: Food and Drug Administration |
heroin opiate addiction adolescent treatment |
Buprenorphine Behavior, Addictive Heroin Narcotic Antagonists Naltrexone |
Central Nervous System Depressants Narcotics Peripheral Nervous System Agents Analgesics Analgesics, Opioid |
Physiological Effects of Drugs Narcotic Antagonists Central Nervous System Depressants Narcotics Pharmacologic Actions Buprenorphine Sensory System Agents |
Therapeutic Uses Naltrexone Analgesics Peripheral Nervous System Agents Central Nervous System Agents Analgesics, Opioid |