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Opiate DependencePhase 3NCT01389167

Naltrexone and Behavioral Drug and HIV Risk Reduction Counseling in Russia

A Phase 3 study testing Vivitrol, Naltrexone (oral) and BDRC in people with Opiate Dependence, run by Yale University at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Opiate Dependence
What is being tested?
Vivitrol, Naltrexone (oral) and BDRC
Could I receive a placebo?
No, everyone receives an active treatment
How many people
320 participants
Where
1 siteRussia
Study dates
Sep 2011to May 2017
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Detoxified volunteers seeking drug rehabilitation treatment will be eligible for the study

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Russia1 site

  • Pavlov University

    Saint Petersburg

Other trials in Russia

About this study

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.

Read the 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.

Being tested
Vivitrol, Naltrexone (oral), BDRC, Medical Management
Medical subject headings
Opioid-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VivitrolDrug

    An extended release naltrexone formulation for intramuscular injection

  • Naltrexone (oral)Drug

    Naltrexone 50 mg pills, daily

  • BDRCBehavioural

    Manual-guided BDRC is a highly structured, educational, prescriptive, and individualized treatment that focuses on the patient's current problem areas that are immediately related to marinating abstinence in order to achieve sustained recovery from drugs. The primary goals of BDRC include education about the disease of opiate dependence and effective treatment approaches, skills and strategies to maintain drug abstinence following detoxification, reduction/cessation of drug and sexual behaviors associated with HIV transmission, and increased engagement in non-drug-related social interactions and pleasurable activities.

  • Medical ManagementBehavioural

    Patient assigned to MM will receive manual-guided medically oriented counseling approximating the current standard of care provided in with NTM the Russian Federation, consisting of an initial introductory session (introduction to NMT and basic education about HIV risks) and subsequent, brief (up to 20 minutes) support and advice sessions once per month.

Study groups in NCT01389167
Study groupRoleWhat they receive
Vivitrol + BDRCExperimentalNot described
Receives: Drug: Vivitrol; Behavioral: BDRC
Vivitrol + Medical ManagementExperimentalNot described
Receives: Drug: Vivitrol; Behavioral: Medical Management
Naltrexone (oral)+BDRCExperimentalNot described
Receives: Drug: Naltrexone (oral); Behavioral: BDRC
Naltrexone (oral) + Medical ManagementExperimentalNot described
Receives: Drug: Naltrexone (oral); Behavioral: Medical Management

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. reductions in sex- and drug-related HIV risk behaviors

    Measured: every month during 6 months of active study phase and during the 6 month follow-up

  2. reductions 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)

    Measured: every month during 6 months of active study phase and during the 6 month follow-up

  3. treatment retention (time to last clinical contact during outpatient treatment phase

    Measured: 6 months

Secondary outcomes (2)

  1. reductions in illicit use of other drugs

    Measured: every month during 6 months of active study phase and during the 6 month follow-up

  2. improvements in vocational, family, social functioning, and quality of life indices

    Measured: every month during 6 months of active study phase and during the 6 month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2011 (estimated)
  2. Study startSep 2011
  3. Primary completionSep 2016
  4. Study completionMay 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
320 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01389167
Sponsor's protocol ID
0907005456
Other IDs
R01DA027405
Status last verified
Jan 2018
First submitted
5 Jul 2011
Last updated
11 Jan 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 40342086

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Vivitrol, Naltrexone (oral) and BDRC in people with Opiate Dependence, run by Yale University at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

reductions in sex- and drug-related HIV risk behaviors (time frame: every month during 6 months of active study phase and during the 6 month follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01389167, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2018.

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