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Addiction Treatment in Russia: Oral vs. Naltrexone Implant

NCT00218426 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 306

Last updated 2019-03-18

Study results available
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Summary

Heroin addiction is a growing problem in Russia; individuals who enter heroin addiction treatment often relapse. Therefore, effective heroin addiction treatments are necessary to prevent relapse. The purpose of this study is to compare oral naltrexone with a naltrexone implant that provides opioid blockade for two months in preventing relapse to heroin addiction in St. Petersburg, Russia.

Conditions

  • Heroin Dependence
  • Opioid-Related Disorders

Interventions

DRUG

naltrexone implant

naltrexone implant is 1000 mg naltrexone

DRUG

oral naltrexone

oral naltrexone 50 mg/day

DRUG

oral placebo naltrexone

oral placebo naltrexone resembles active medication

DRUG

placebo implant

placebo implant resembles active medication

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • St. Petersburg State Pavlov Medical University

    collaborator OTHER

  • University of Pennsylvania

    lead OTHER

Principal Investigators

  • George Woody, MD · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2009-06-30
Completion
2010-11-04

Countries

  • United States
  • Russia

Study Locations

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Entities

Companies

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 NCT00218426 on ClinicalTrials.gov