- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00182572
Science-Based Treatment for Opioid-Dependent Adolescents
August 11, 2008 updated by: National Development and Research Institutes, Inc.
The purpose of this study is to evaluate ways to optimize outcomes from combined behavioral-pharmacological treatment for opioid-dependent youth.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
80
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lisa Marsch, PhD
- Phone Number: 212-636-1253
- Email: marsch@ndri.org
Study Contact Backup
- Name: Ramon Solhkhah, MD
- Phone Number: 212-523-3069
- Email: RSolhkha@chpnet.org
Study Locations
-
-
New York
-
New York, New York, United States, 10025
- Recruiting
- Behavioral Science Research Unit, St. Luke's Hospital
-
Principal Investigator:
- Lisa Marsch, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
opiate use
|
Secondary Outcome Measures
Outcome Measure |
---|
HIV risk behavior
|
treatment retention
|
other drug use
|
opiate agonist and withdrawal effects
|
psychological status
|
family relations
|
motivation to change drug use
|
opiate craving
|
criminal activity
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Lisa Marsch, PhD, National Development and Research Institutes, Inc.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2005
Study Registration Dates
First Submitted
September 10, 2005
First Submitted That Met QC Criteria
September 10, 2005
First Posted (Estimate)
September 16, 2005
Study Record Updates
Last Update Posted (Estimate)
August 12, 2008
Last Update Submitted That Met QC Criteria
August 11, 2008
Last Verified
August 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Narcotic-Related Disorders
- Opioid-Related Disorders
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Opioid
- Narcotics
- Narcotic Antagonists
- Alcohol Deterrents
- Buprenorphine
- Naltrexone
Other Study ID Numbers
- R01DA018297 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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