NCT00218426 is a Phase 2/Phase 3 clinical trial of naltrexone implant in Heroin Dependence, sponsored by University of Pennsylvania.

Who is sponsoring NCT00218426?

NCT00218426 is sponsored by University of Pennsylvania.

What drugs are being tested in NCT00218426?

Interventions in NCT00218426: naltrexone implant, oral naltrexone, oral placebo naltrexone, placebo implant.

What condition does NCT00218426 study?

NCT00218426 studies Heroin Dependence, Opioid-Related Disorders.

Is NCT00218426 still recruiting?

NCT00218426 is currently completed. Last updated 28 February 2019.

Are results published for NCT00218426?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-02-28 · How we verify

NCT00218426

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Addiction Treatment in Russia: Oral and Depot Naltrexone

Completed Phase 2/Phase 3 Results posted Last updated 28 February 2019

What this trial tests

Phase 2/Phase 3 trial testing naltrexone implant in Heroin Dependence in 306 participants. Completed in 4 November 2010.

Timeline

1 July 2006

Primary endpoint
1 June 2009

4 November 2010

Quick facts

Lead sponsor	University of Pennsylvania
Phase	Phase 2/Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	306
Start date	1 July 2006
Primary completion	1 June 2009
Estimated completion	4 November 2010
Sites	2 locations across United States, Russia

Drugs / interventions tested

naltrexone implant — full drug profile →
oral naltrexone — full drug profile →
oral placebo naltrexone
placebo implant

Conditions studied

Heroin Dependence — all drugs for Heroin Dependence →
Opioid-Related Disorders — all drugs for Opioid-Related Disorders →

Sponsor

University of Pennsylvania

Who can join

Adults 18 to 50, any sex, with Heroin Dependence or Opioid-Related Disorders. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Retention Without Relapse to Heroin Addiction (Measured at Month 6)
Time frame: 6 months
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 attri

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Sustained-release naltrexone for opioid dependence.
Lobmaier P, Kornør H, Kunøe N, Bjørndal A. · · 2008 · cited 49× · PMID 18425938 · DOI 10.1002/14651858.cd006140.pub2
Anhedonia, depression, anxiety, and craving in opiate dependent patients stabilized on oral naltrexone or an extended release naltrexone implant.
Krupitsky E, Zvartau E, Blokhina E, Verbitskaya E, et al · · 2016 · cited 34× · PMID 27436632 · DOI 10.1080/00952990.2016.1197231
Novel medications to treat addictive disorders.
Montoya ID, Vocci F. · · 2008 · cited 16× · PMID 18803912 · DOI 10.1007/s11920-008-0063-9

Verify or expand the search:

Other trials of naltrexone implant

Trials testing the same drug.

NCT05382091 — Evaluation of the O'Neil Long Acting Naltrexone Implant in Opioid Dependent Persons · Phase 2 · not yet recruiting
NCT03810495 — The O'Neil Long Acting Naltrexone Implant (OLANI) Pharmacokinetic (PK)/Safety Study in Healthy Volunteers · Phase 1 · completed

Other University of Pennsylvania trials

Trials by the same sponsor.

NCT06081153 — Mechanistic Clinical Trial of PCSK9 Inhibition for AAA · EARLY_PHASE1 · not yet recruiting
NCT07415772 — Effect of cTBS on Startle and TMS-evoked BOLD · NA · not yet recruiting
NCT07489430 — DaxibotulinumtoxinA for Blepharospasm · Phase 2 · not yet recruiting
NCT07463131 — Negative Income Tax Trial · NA · not yet recruiting
NCT06645769 — Na-Phenylbutyrate VAscular Trial · EARLY_PHASE1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00218426 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Pennsylvania
Last refreshed: 28 February 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00218426.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing