A Phase 2 interventional study of buprenorphine and naltrexone in Opioid-Dependence Among Adolescents, sponsored by National Development and Research Institutes, Inc.. Status unknown at 1 site in United States. Open to participants aged 13 Years to 18 Years. Per ClinicalTrials.gov, last updated 2008-08-12.
Sponsored by National Development and Research Institutes, Inc. · Phase 2, Interventional, and Treatment
The purpose of this study is to evaluate ways to optimize outcomes from combined behavioral-pharmacological treatment for opioid-dependent youth.
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.
1,411 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.
This study's planned enrollment of 80 is above the median of 63 across 1,123 interventional studies indexed under Opioid-Related Disorders.
Browse Opioid-Related Disorders studies →National Development and Research Institutes, Inc. is the lead sponsor of 22 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
opiate use
treatment retention
other drug use
HIV risk behavior
opiate agonist and withdrawal effects
psychological status
family relations
motivation to change drug use
opiate craving
criminal activity
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National Development and Research Institutes, Inc.