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Comparison of Buprenorphine/Naloxone With Naltrexone in Opioid Dependent Adolescents

NCT01015066 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2014-06-10

No results posted yet for this study

Summary

This study is designed to determine the relative effectiveness of buprenorphine/naloxone (Suboxone) pharmacotherapy versus naltrexone pharmacotherapy for treatment retention, relapse prevention and opioid craving reduction among opioid-dependent adolescents and young adults. The investigators hypothesize that naltrexone treatment is as effective as buprenorphine/naloxone for these treatment outcomes.

Conditions

  • Opiate Addiction

Interventions

DRUG

Buprenorphine/naloxone

Sublingual tablets, 2/0.5mg (ratio buprenorphine:naloxone = 4:1), three times a day for six months (doses may be adjusted based on an individual's response)

DRUG

Naltrexone

Oral tables, 50 mg/d, once a day for six months

Sponsors & Collaborators

  • State University of New York at Buffalo

    lead OTHER

Principal Investigators

  • Richard D Blondell, MD · SUNY Buffalo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01015066 on ClinicalTrials.gov