Science-Based Treatment for Opioid-Dependent Adolescents

NCT ID: NCT00182572

Last Updated: 2008-08-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-07-31

Brief Summary

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

Detailed 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.

Conditions

Opioid-Dependence Among Adolescents

Keywords

heroin; opiate; addiction; adolescent; treatment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

buprenorphine

Intervention Type: DRUG

naltrexone

Intervention Type: DRUG

behavior therapy

Intervention Type: PROCEDURE

voucher-based contingency management

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Luke's-Roosevelt Hospital Center

OTHER

Sponsor Role: collaborator

National Development and Research Institutes, Inc.

OTHER

Sponsor Role: lead

Principal Investigators

Lisa Marsch, PhD

Role: PRINCIPAL_INVESTIGATOR

National Development and Research Institutes, Inc.

Locations

Behavioral Science Research Unit, St. Luke's Hospital

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Lisa Marsch, PhD

Role: CONTACT

Phone: 212-636-1253

Email: marsch@ndri.org

Ramon Solhkhah, MD

Role: CONTACT

Phone: 212-523-3069

Email: RSolhkha@chpnet.org

References

Marsch LA, Moore SK, Borodovsky JT, Solhkhah R, Badger GJ, Semino S, Jarrett K, Condon KD, Rossettie K, Vincent P, Hajizadeh N, Ducat E. A randomized controlled trial of buprenorphine taper duration among opioid-dependent adolescents and young adults. Addiction. 2016 Aug;111(8):1406-15. doi: 10.1111/add.13363. Epub 2016 Apr 21.

Reference Type: DERIVED

PMID: 26918564 (View on PubMed)

Other Identifiers

R01DA018297

Identifier Type: NIH

Identifier Source: org_study_id

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