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NCT00078130 Clinical Trial

Buprenorphine/Naloxone - Facilitated Rehabilitation for Opioid Dependent Adolescents - 1

Opioid-Related Disorders Clinical Trial

Official title:
Bup/Nx - Facilitated Rehab for Opioid Dependent Adolescents

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00078130
Other study ID # NIDA-CTN-0010-1
Secondary ID
Status Completed
Phase Phase 3
First received February 19, 2004
Last updated January 11, 2017
Start date July 2003
Est. completion date January 2006

Study information
Verified date October 2016
Source National Institute on Drug Abuse (NIDA)
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare two 3-month treatments for adolescents/young adults who are addicted to heroin: buprenorphine/naloxone combined with psychosocial therapy and treatment as usual, a 7-14 day detoxification with buprenorphine and three weeks of psychosocial therapy.

Recruitment information / eligibility
Status Completed
Enrollment 223
Est. completion date January 2006
Est. primary completion date January 2006
Accepts healthy volunteers No
Gender All
Age group 14 Years to 21 Years
Eligibility Male and non-pregnant female subjects seeking outpatient treatment for opioid dependence with physiological features without serious medical or psychiatric disorders.

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Buprenorphine/naloxone

Locations
Country Name City State
United States ASAP Albuquerque New Mexico
United States Mountain Manor Baltimore Maryland
United States Duke Addictions Program Durham North Carolina
United States Mercy Hospital Portland Maine

Sponsors (1)
Lead Sponsor Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Opiate abstinence
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