Addiction Treatment in Russia: Oral vs. Naltrexone Implant
4 other identifiers
interventional
306
2 countries
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2006
Typical duration for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 16, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedStudy Start
First participant enrolled
July 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 4, 2010
CompletedResults Posted
Study results publicly available
February 27, 2019
CompletedMarch 18, 2019
February 1, 2019
2.9 years
September 16, 2005
February 1, 2019
February 28, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Retention Without Relapse to Heroin Addiction (Measured at Month 6)
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.
6 months
Secondary Outcomes (10)
Number of Subjects Who Dropped Out of Treatment
6 months
Positive Opioid Urine Test
6 months
Use of Alcohol
6 months
Composite Score of Psychiatric Problems
6 months
HIV Risk (Baseline)
baseline
- +5 more secondary outcomes
Study Arms (3)
ONP + DNI
ACTIVE COMPARATOROral naltrexone placebo (ONP) + Depot Naltrexone Implant (DNI) 1000 mg
ON + DNIP
ACTIVE COMPARATOROral naltrexone (ON) 50 mg + Depot Naltrexone placebo Implant (DNIP)
ONP + DNIP
PLACEBO COMPARATOROral placebo naltrexone + placebo naltrexone implant
Interventions
oral placebo naltrexone resembles active medication
placebo implant resembles active medication
Eligibility Criteria
You may qualify if:
- Current opioid dependence
- Recently completed opioid detoxification
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Pennsylvanialead
- National Institute on Drug Abuse (NIDA)collaborator
- St. Petersburg State Pavlov Medical Universitycollaborator
Study Sites (2)
University of Pennsylvania
Philadelphia, Pennsylvania, 19104 6178, United States
Pavlov Medical University
Saint Petersburg, 197022, Russia
Related Publications (2)
Kornor H, Lobmaier PPK, Kunoe N. Sustained-release naltrexone for opioid dependence. Cochrane Database Syst Rev. 2025 May 9;5(5):CD006140. doi: 10.1002/14651858.CD006140.pub3.
PMID: 40342086DERIVEDKrupitsky E, Zvartau E, Blokhina E, Verbitskaya E, Wahlgren V, Tsoy-Podosenin M, Bushara N, Burakov A, Masalov D, Romanova T, Tyurina A, Palatkin V, Yaroslavtseva T, Pecoraro A, Woody G. Anhedonia, depression, anxiety, and craving in opiate dependent patients stabilized on oral naltrexone or an extended release naltrexone implant. Am J Drug Alcohol Abuse. 2016 Sep;42(5):614-620. doi: 10.1080/00952990.2016.1197231. Epub 2016 Jul 19.
PMID: 27436632DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Limitations include limited amount of data on patients who did not remain in treatment, thus making it difficult to obtain more accurate information on the proportions with relapse at 9- and 12- month follow-ups and other secondary outcomes.
Results Point of Contact
- Title
- Dr. George E Woody
- Organization
- University of Pennsylvania
Study Officials
- PRINCIPAL INVESTIGATOR
George Woody, MD
University of Pennsylvania
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2005
First Posted
September 22, 2005
Study Start
July 1, 2006
Primary Completion
June 1, 2009
Study Completion
November 4, 2010
Last Updated
March 18, 2019
Results First Posted
February 27, 2019
Record last verified: 2019-02