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NCT00218426 · ClinicalTrials.gov registry record · Phase 2

Addiction Treatment in Russia: Oral vs. Naltrexone Implant

A Phase 2 study, sponsored by University of Pennsylvania.

Completed
Registry status
Phase 2
Development phase
306
Enrollment target

NCT00218426: Completed Phase 2 study, sponsored by University of Pennsylvania.

NCT00218426 is a Phase 2 study that has completed, run by University of Pennsylvania. The registered enrollment target is 306 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (130% higher). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT00218426, a Phase 2 study, has completed, sponsored by University of Pennsylvania.

COMPLETED
Registry status
Phase 2
Development phase
306 participants
Enrollment target

Study 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.

Primary Outcome

Survival analysis (Kaplan-Meier survival functions with log-rank Cox-Mantel criteria for group comparison was used to determine the primary outcome of retention, defined as not missing 2 consecutive counseling sessions and not having a relapse. Because this outcome combined patients who failed to keep appointments with those who kept appointments but relapsed, the proportion of non-survivors attributable to proven relapse.

Interventions

  • DRUG oral naltrexone
  • DRUG naltrexone implant
  • DRUG oral placebo naltrexone
  • DRUG placebo implant

Trial Details

FieldValue
Enrollment Target 306 participants
Start Date 2006-07
Est. Completion 2010-11-04
Phase Phase 2
University of Pennsylvania

1,423 total trials

What the finished NCT00218426 record still lists

NCT00218426 is an interventional study that assigns participants to a tested intervention. The registered 306 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (130% higher).

The record links to 0 conditions, and to 4 interventions - of which oral naltrexone is the first listed.

NCT00218426 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00218426 about?

NCT00218426 is a clinical study titled "Addiction Treatment in Russia: Oral vs. Naltrexone Implant". 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 b...

What is the current status of trial NCT00218426?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 306 participants. The study started on 2006-07. Estimated completion is 2010-11-04.

What interventions are being tested in trial NCT00218426?

The interventions under investigation include: oral naltrexone (DRUG), naltrexone implant (DRUG), oral placebo naltrexone (DRUG), placebo implant (DRUG).

Who is sponsoring clinical trial NCT00218426?

This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00218426's enrollment target sits among peer trials

306 165th of 2000 higher than 1,835 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00218426, the US trial registry maintained by the National Library of Medicine. NCT00218426 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.