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HIVPhase 2NCT01101815

Adherence to HIV Therapy in Heroin Addicts: Oral vs XR-NTX

A Phase 2 study testing Oral Naltrexone, Naltrexone Implant and Group Drug Counseling Manual Driven in people with HIV and Substance Abuse, run by University of Pennsylvania at 2 sites 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

Substance use, particularly the compulsive behaviors associated with addiction, lead to unhealthy behaviors including non-adherence to antiretroviral therapy (ART) and treatment failure. Read more about this study

Who is it for?
Ages 18 to 64 years
Conditions the study is for
HIV, Substance Abuse, HIV Infections
What is being tested?
Oral Naltrexone, Naltrexone Implant and Group Drug Counseling Manual Driven
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
2 sitesRussia
Study dates
Jun 2010to Dec 2016
Phase
Phase 2
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 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • must be HIV+ men/women starting their first episode of ART or starting a new ART treatment episode and was prescribed medications that suppressed the virus to <400 copies during their last treatment
  • understand that they will be prescribed ART medications that they have never received and to which their virus is likely to be susceptible
  • viral loads of 1,000 copies or more
  • meet the Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV) criteria for opioid dependence in early remission
  • have a negative opiate urine toxicology and alcohol breath test
  • show no evidence of physiologic dependence on physical exam and following a naltrexone challenge
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  • have a stable address in the St. Petersburg or Leningrad Region of Russia area
  • have a valid telephone number where subject can be reached
  • have a negative pregnancy test and use adequate contraception
  • have the ability to give informed consent as judged by ability to read the consent and correctly answer 9 of 10 questions about the study on a quiz that will be administered after discussing the study and reading the consent

Who cannot join

  • not be currently psychotic as determined by a psychiatric examination (i.e.; schizophrenia, paranoid disorder, mania)
  • not have current suicidal or homicidal ideation requiring immediate attention as determined at baseline assessment
  • not have an uncontrolled seizure disorder
  • not have cognitive impairment with an inability to read and understand the consent
  • not have significant laboratory abnormality such as >2 grade anemia
  • not have hepatic transaminase levels >5 times the upper limit of normal
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  • not have serum creatinine >1.5 times the upper limit of normal
  • not have pending legal charges with impending incarceration
  • not be concurrently participating in another treatment study
  • not currently taking naltrexone

Trial locations and contacts

2 sites in 1 country.

Russia2 sites

  • Botkin Infectious Disease Hospital

    Leningrad Region, 188661

  • Botkin Infectious Disease Hospital

    Saint Petersburg, Russian Federation, 197376

Other trials in Russia

About this study

Official title: Adherence to HIV Therapy in Heroin Addicts: Oral vs. Extended Release Naltrexone

Substance use, particularly the compulsive behaviors associated with addiction, lead to unhealthy behaviors including non-adherence to antiretroviral therapy (ART) and treatment failure. High on the list of disorders leading to non-adherence is heroin addiction as a wide range of impulsive, high-risk behaviors accompanies it. The science of adherence would be improved by developing new methods to prevent relapse to heroin addiction, especially methods that can be used in settings that are not limited by the aims to test such a method using an implantable naltrexone formulation (IN) that is approved in Russia and blocks opioid effects for 3 months. The efficacy of the IN should be better than oral naltrexone (ON) because it does not depend on daily behavior to take a tablet and maintains a constant plasma level for months, which should result in sustained blockade, less relapse, and better ART adherence and treatment response.

Read the detailed description

This is a double blind, double-dummy, placebo controlled, randomized trial of a 48-week course of implant naltrexone vs. oral naltrexone, each arm with drug counseling every two weeks, for 200 HIV+ patients who are in early remission from opioid dependence, and who are interested in relapse prevention treatment medication, and starting their first episode of antiretroviral therapy at the Botkin Infectious Disease Hospital in St. Petersburg or the Leningrad Regional AIDS Center. Early remission was chosen because relapse risk is the highest at this point, thus maximizing the chances for detecting a naltrexone effect. The first antiretroviral therapy treatment episode was chosen because it is feasible (relatively few opioid addicted Russians have been treated with antiretroviral therapy), and because the virus is less likely to have developed secondary resistance.

Participants will be recruited from the AIDS and addiction programs and who meet study admission criteria will be stratified within each site according to baseline viral load (>100,000 copies/<100,000 copies) and cluster of differentiation 4 (CD4) count (>50/<50 copies). Participants will be randomized to a treatment condition, receive a naloxone challenge, and if pass be prescribed oral naltrexone or oral placebo and implant/implant placebo), and given a schedule for addiction counseling and HIV treatment appointments. A 2-week supply of oral medication will be provided at each bi-weekly counseling session, and will be re-implanted at weeks 12, 24, and 36. Only the research pharmacist will know the group assignments, however the blind can be broken in case of emergency.

The primary outcome measure will be to compare implanted naltrexone versus oral naltrexone on ability to achieve a viral load of <400 copies at weeks 24 and 48.

Secondary outcomes are to compare the efficacy of the two addiction treatments; to study the adherence to antiretroviral therapy; to evaluate time to relapse and the number of days to relapsed; to evaluate decline in CD4 counts; to evaluate HIV risk behavior; to evaluate opioid positive urine tests; and to evaluate the number of days that patients will keep their scheduled appointments. The Investigator will also monitor psychiatric symptoms, other drug use, and overall adjustment.

Being tested
Oral Naltrexone, Naltrexone Implant, Group Drug Counseling Manual Driven
Keywords
Viral Loads, Naltrexone, HIV Risk, Substance Abuse
Medical subject headings
Substance-Related Disorders, HIV Infections

What participants receive

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

  • Oral NaltrexoneDrug

    Also called Revia

    50 mg/day-oral

  • Naltrexone ImplantDrug

    Also called Prodetoxon

    monthly-implant

  • Group Drug Counseling Manual DrivenBehavioural

    Given to both groups biweekly, weeks 2 - 48. Counseling will consist of three components: 1) giving advice, support and clinical management aimed to maintain abstinence; 2) adherence enhancement to encourage keeping appointments, taking ART medications as prescribed and getting treatment for associated problems; and 3) reviewing behaviors that are likely to spread HIV and other infectious diseases, and counseling on how to stop them.

Study groups in NCT01101815
Study groupRoleWhat they receive
Oral Naltrexone + ARTActive comparatorNaltrexone (oral). 50 mg maintenance daily for 48 weeks, plus group drug counseling manual driven, N= 100
Receives: Drug: Oral Naltrexone; Behavioral: Group Drug Counseling Manual Driven
Naltrexone Implant + ARTActive comparatorNaltrexone Implant + ART. Monthly maintenance for 48 Weeks plus, group drug counseling manual driven, N=100
Receives: Drug: Naltrexone Implant; Behavioral: Group Drug Counseling Manual Driven

What is being measured

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

  1. Adherence Oral (ON) vs Implant (IN) naltrexone

    The primary aim is to compare the ability IN vs ON to achieve a viral load of <400 copies at weeks 24 and 48

    Measured: 48 weeks

Secondary outcomes (1)

  1. Compare efficacy of the two treatments

    1. Adherence to ART
    2. Time to relapse;
    3. Number of days relapsed;
    4. Decline in CD4 counts;
    5. HIV risk behavior;
    6. Opioid positive urine tests;
    7. Number of days kept scheduled appointments;
    8. Psychiatric symptoms, other drug use, overall adjustment

    Measured: 48 weeks

Timeline

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

  1. First posted12 Apr 2010 (estimated)
  2. Study startJun 2010
  3. Primary completionDec 2016
  4. Study completionDec 2016

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01101815
Sponsor's protocol ID
R01DA-0263360-01
Other IDs
R01DA026336
Status last verified
Feb 2018
First submitted
8 Apr 2010
Last updated
8 Nov 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

  • Krupitsky E, Blokhina E, Zvartau E, Verbitskaya E, Lioznov D, Yaroslavtseva T, Palatkin V, Vetrova M, Bushara N, Burakov A, Masalov D, Mamontova O, Langleben D, Poole S, Gross R, Woody G. Slow-release naltrexone implant versus oral naltrexone for improving treatment outcomes in people with HIV who are addicted to opioids: a double-blind, placebo-controlled, randomised trial. Lancet HIV. 2019 Apr;6(4):e221-e229. doi: 10.1016/S2352-3018(18)30362-X. Epub 2019 Mar 14.

    PubMed 30880163

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Oral Naltrexone, Naltrexone Implant and Group Drug Counseling Manual Driven in people with HIV and Substance Abuse, run by University of Pennsylvania at 2 sites 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 10 inclusion and 10 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 8 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Adherence Oral (ON) vs Implant (IN) naltrexone (time frame: 48 weeks). 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 NCT01101815, which also lists 2 linked publications.

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 8 Nov 2018.

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