Science-Based Treatment for Opioid-Dependent Adolescents

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by National Development and Research Institutes, Inc..
Recruitment status was  Recruiting
Sponsor:
Collaborator:
St. Luke's-Roosevelt Hospital Center
Information provided by:
National Development and Research Institutes, Inc.
ClinicalTrials.gov Identifier:
NCT00182572
First received: September 10, 2005
Last updated: August 11, 2008
Last verified: August 2008
  Purpose

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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Science-Based Treatment for Opioid-Dependent Adolescents

Resource links provided by NLM:


Further study details as provided by National Development and Research Institutes, Inc.:

Primary Outcome Measures:
  • opiate use

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 80
Study Start Date: July 2005
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.

  Eligibility

Ages Eligible for Study:   13 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00182572

Contacts
Contact: Lisa Marsch, PhD 212-636-1253 marsch@ndri.org
Contact: Ramon Solhkhah, MD 212-523-3069 RSolhkha@chpnet.org

Locations
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         
Sponsors and Collaborators
National Development and Research Institutes, Inc.
St. Luke's-Roosevelt Hospital Center
Investigators
Principal Investigator: Lisa Marsch, PhD National Development and Research Institutes, Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00182572     History of Changes
Other Study ID Numbers: R01 DA018297
Study First Received: September 10, 2005
Last Updated: August 11, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by National Development and Research Institutes, Inc.:
heroin
opiate
addiction
adolescent
treatment

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Mental Disorders
Buprenorphine
Analgesics, Opioid
Naltrexone
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotic Antagonists
Narcotics

ClinicalTrials.gov processed this record on April 15, 2014