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Science-Based Treatment for Opioid-Dependent Adolescents

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2008 by National Development and Research Institutes, Inc..
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00182572
First Posted: September 16, 2005
Last Update Posted: August 12, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
St. Luke's-Roosevelt Hospital Center
Information provided by:
National Development and Research Institutes, Inc.
  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
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Science-Based Treatment for Opioid-Dependent Adolescents

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

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00182572     History of Changes
Other Study ID Numbers: R01DA018297 ( U.S. NIH Grant/Contract )
First Submitted: September 10, 2005
First Posted: September 16, 2005
Last Update Posted: August 12, 2008
Last Verified: August 2008

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

Additional relevant MeSH terms:
Buprenorphine
Naltrexone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists