Phase 3
N=306
Addiction Treatment in Russia: Oral vs. Naltrexone Implant
Heroin Dependence · Opioid-Related Disorders
Bottom Line
View on ClinicalTrials.gov: NCT00218426 ↗Enrolled (actual)
306
Serious AEs
0.3%
Results posted
Feb 2019
Primary outcome: Primary: Retention Without Relapse to Heroin Addiction (Measured at Month 6) — 54; 16; 11 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- naltrexone implant (Drug); oral naltrexone (Drug); oral placebo naltrexone (Drug); placebo implant (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Retention Without Relapse to Heroin Addiction (Measured at Month 6) |
54; 16; 11 | — |
| SECONDARY Number of Subjects Who Dropped Out of Treatment |
54; 16; 11 | — |
| SECONDARY Positive Opioid Urine Test |
.427; .636; .341 | — |
| SECONDARY Use of Alcohol |
10.2; 9.0; 9.6 | — |
| SECONDARY Composite Score of Psychiatric Problems |
0.19; 0.15; 0.18 | — |
| SECONDARY HIV Risk (Baseline) |
8.1; 8.0; 8.7 | — |
| SECONDARY Global Assessment Form (GAF) |
62.8; 64.7; 62.5 | — |
| SECONDARY Amphetamine Drug Use |
6; 12; 18 | — |
| SECONDARY Cocaine Drug Use |
0; 0; 0 | — |
| SECONDARY Marijuana Drug Use |
22; 35; 25 | — |
| SECONDARY Benzodiazepine Drug Use |
10; 15; 9 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Current opioid dependence
- Recently completed opioid detoxification
Exclusion Criteria
- Serious medical or psychiatric condition requiring immediate hospitalization or that would make participation in the study hazardous
- Planning to leave the study area within the 12 months following study entry
- Imminent incarceration
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT00218426). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.