Science-Based Treatment for Opioid-Dependent Adolescents

National Development and Research Institutes, Inc.

Status and phase: Unknown; Phase 2

Conditions: Opioid-Dependence Among Adolescents

Treatments: Drug: buprenorphine; Procedure: voucher-based contingency management; Procedure: behavior therapy; Drug: naltrexone

Study type: Interventional

Funder types: Other

Identifiers

NCT00182572

R01DA018297

Details and patient eligibility

About

The purpose of this study is to evaluate ways to optimize outcomes from combined behavioral-pharmacological treatment for opioid-dependent youth.

Full description

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 13 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• clinical diagnosis of opioid dependence
• ages 13-18 years

Exclusion criteria

• active psychosis
• active suicidality
• major medical problems (e.g., cardiovascular disease)
• pregnancy
• require inpatient detoxification from non-opiate drugs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind