Naltrexone and Behavioral Drug and HIV Risk Reduction Counseling in Russia
Information source: Yale University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Opiate Dependence
Intervention: Vivitrol (Drug); Naltrexone (oral) (Drug); BDRC (Behavioral); Medical Management (Behavioral)
Phase: Phase 3
Status: Recruiting
Sponsored by: Yale University Overall contact: Evgeny Krupitsky, Ph.D., M.D., Phone: +7-812-365-2217, Email: kruenator@gmail.com
Summary
The long-term goals of this study are to foster development and dissemination of
evidence-based behavioral and pharmacological treatments to reduce HIV transmission,
injection drug use (IDU), and heroin use in Russia. This study will examine the effects of
combining behavioral therapy with naltrexone pharmacotherapy for the treatment of opiate
dependence and reduction of HIV risks in opiate dependent individuals. Specifically the
study will determine whether extended-release injection naltrexone has greater efficacy and
is more cost-effective than oral naltrexone maintenance, whether behavioral drug and HIV
risk reduction counseling (BDRC) combined with brief, medical management (MM) has greater
efficacy and is more cost-effective than MM only, and whether particular combinations of
medication formulation and counseling (MM only or MM plus BDRC) have greater efficacy or are
more cost-effective than other combinations.
Clinical Details
Official title: Naltrexone and Behavioral Drug and HIV Risk Reduction Counseling in Russia
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: reductions in sex- and drug-related HIV risk behaviorsreductions in illicit opiate use (maximum consecutive days of abstinence following detoxification and number of days of heroin or illicit opiate use in the past 30 days) treatment retention (time to last clinical contact during outpatient treatment phase
Secondary outcome: reductions in illicit use of other drugsimprovements in vocational, family, social functioning, and quality of life indices
Detailed description:
With an estimated 1. 6-4 million opiate users (majority with injection drug use (IDU)) and
more than 940,000 HIV infected individuals (80% linked to IDU), the Russian Federation is
facing the prospect of an explosive HIV epidemic. Currently in Russia, inpatient
detoxification followed by oral naltrexone maintenance (NMT) is the only pharmacologic
treatment for opiate dependence. Evidence-based counseling to reduce HIV transmission and
relapse following detoxification is not widely available or routinely provided. Several
considerations, including data from our preliminary studies, suggest that the efficacy of
NMT may be improved by using extended-release naltrexone (XR/NTX) instead of oral naltrexone
(O/NTX) and by combining NMT with behavioral drug and HIV risk reduction counseling (BDRC).
BDRC may also improve medication adherence and promote behavioral change leading to reduced
relapse risk, IDU, and other drug- and sex-related HIV risk behaviors. However, the
efficacy and cost-effectiveness for reducing drug- and sex-related HIV risk behaviors and
increasing duration of opioid abstinence of the various combinations of naltrexone
formulation (O/NTX vs. XR/NTX) and counseling (MM only or combined with BDRC) have not been
systematically evaluated. Consequently, we are proposing a 2x2 factorial randomized
clinical trial evaluating the efficacy and cost-effectiveness of two medication formulations
(O/NTX and XR/NTX) and two manual-guided counseling conditions (MM only or MM+BDRC) and the
potential interactions between medications and counseling conditions. Following
detoxification, opiate dependent subjects (N=320) will be randomly assigned to 6 months of
treatment in one of four treatment groups: O/NTX+MM, XR/NTX+MM, O/NTX+MM+BDRC, or
XR/NTX+MM+BDRC. Primary outcome measures include reductions in sex- and drug-related HIV
risk behaviors, reductions in illicit opiate use, and treatment retention. Other outcome
measures include reductions in frequency of opiate or other drug use, health status and
healthcare utilization, criminal behavior and arrests, and improvements in vocational and
family functioning and quality of life. All study participants will be assessed at baseline
and monthly during the 6 month treatment phase and for 6 months following the active
treatment phase. Data analyses will focus on the intention-to treat sample. The study
results will allow evaluation of whether XR/NTX has superior efficacy or is more
cost-effective than O/NTX, whether BDRC plus MM has superior efficacy or is more
cost-effective than MM only, and whether particular combinations of medications and
counseling have superior efficacy or are more cost-effective than other combinations.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Detoxified volunteers seeking drug rehabilitation treatment will be eligible for the
study
Exclusion Criteria:
- Current suicide or homicide risk
- Current psychotic disorder or major depression
- Inability to understand the consent form or assessments
- Pregnancy
- Acute hepatitis, liver failure, or liver enzymes greater than 3 times the upper limit
of normal.
Locations and Contacts
Evgeny Krupitsky, Ph.D., M.D., Phone: +7-812-365-2217, Email: kruenator@gmail.com
Pavlov State Medical University, St Petersburg, Russian Federation; Not yet recruiting Evgeny Krupitsky
Pavlov University, St. Petersburg, Russian Federation; Recruiting Evgeny Krupitsky, Ph.D., M.D., Phone: +7-812-365-2217, Email: kruenator@gmail.com Edwin Zvartau, M.D., Ph.D., Principal Investigator
Additional Information
Starting date: September 2011
Last updated: January 21, 2015
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