CClinicalTrials.gg
Status unknownNCT00182572Updated Aug 12, 2008

Science-Based Treatment for Opioid-Dependent Adolescents

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 sponsor has not verified this record recently (last verified Aug 2008), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
13 Years to 18 Years
Sex
All
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Study summary

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

Read the 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.

02

Conditions studied

  • Opioid-Dependence Among Adolescents

Keywords

  • heroin
  • opiate
  • addiction
  • adolescent
  • treatment
03

In context

Opioid-Related Disorders

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
13 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • active psychosis
  • active suicidality
  • major medical problems (e.g., cardiovascular disease)
  • pregnancy
  • require inpatient detoxification from non-opiate drugs
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
80 participants (estimated)

Interventions

  • Drugbuprenorphine
  • Drugnaltrexone
  • Procedurebehavior therapy
  • Procedurevoucher-based contingency management
06

What researchers measure

Primary outcomes

  1. opiate use

Secondary outcomes

  1. treatment retention

  2. other drug use

  3. HIV risk behavior

  4. opiate agonist and withdrawal effects

  5. psychological status

  6. family relations

  7. motivation to change drug use

  8. opiate craving

  9. criminal activity

07

Study locations

1 of 1 sites recruiting
  • Behavioral Science Research Unit, St. Luke's Hospital
    New York, New York 10025, United States
    • Lisa Marsch, PhD · Principal investigator
    Recruiting
08

References and documents

Publications

  • 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. PubMed 26918564 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 12, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00182572
Lead sponsor
National Development and Research Institutes, Inc.
Collaborators
St. Luke's-Roosevelt Hospital Center
First posted
Sep 16, 2005
Start date
Jul 2005
Last update
Aug 12, 2008

Study contacts

Lisa Marsch, PhD
Contact
marsch@ndri.org
212-636-1253
Ramon Solhkhah, MD
Contact
RSolhkha@chpnet.org
212-523-3069
Lisa Marsch, PhD
principal investigator · National Development and Research Institutes, Inc.
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2008. You cannot join it, but the record below documents what was studied.

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