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Science-Based Treatment for Opioid-Dependent Adolescents

Primary Purpose

Opioid-Dependence Among Adolescents

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
buprenorphine
naltrexone
behavior therapy
voucher-based contingency management
Sponsored by
National Development and Research Institutes, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid-Dependence Among Adolescents focused on measuring heroin, opiate, addiction, adolescent, treatment

Eligibility Criteria

13 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Behavioral Science Research Unit, St. Luke's HospitalRecruiting

Outcomes

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

Full Information

First Posted
September 10, 2005
Last Updated
August 11, 2008
Sponsor
National Development and Research Institutes, Inc.
Collaborators
St. Luke's-Roosevelt Hospital Center
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1. Study Identification

Unique Protocol Identification Number
NCT00182572
Brief Title
Science-Based Treatment for Opioid-Dependent Adolescents
Official Title
Science-Based Treatment for Opioid-Dependent Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Unknown status
Study Start Date
July 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Development and Research Institutes, Inc.
Collaborators
St. Luke's-Roosevelt Hospital Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-Dependence Among Adolescents
Keywords
heroin, opiate, addiction, adolescent, treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
buprenorphine
Intervention Type
Drug
Intervention Name(s)
naltrexone
Intervention Type
Procedure
Intervention Name(s)
behavior therapy
Intervention Type
Procedure
Intervention Name(s)
voucher-based contingency management
Primary Outcome Measure Information:
Title
opiate use
Secondary Outcome Measure Information:
Title
treatment retention
Title
other drug use
Title
HIV risk behavior
Title
opiate agonist and withdrawal effects
Title
psychological status
Title
family relations
Title
motivation to change drug use
Title
opiate craving
Title
criminal activity

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa Marsch, PhD
Phone
212-636-1253
Email
marsch@ndri.org
First Name & Middle Initial & Last Name or Official Title & Degree
Ramon Solhkhah, MD
Phone
212-523-3069
Email
RSolhkha@chpnet.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Marsch, PhD
Organizational Affiliation
National Development and Research Institutes, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Behavioral Science Research Unit, St. Luke's Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Marsch, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
26918564
Citation
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.
Results Reference
derived

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Science-Based Treatment for Opioid-Dependent Adolescents

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