AzTrials
AzTrials

Opiate DependencePhase 2NCT00398008

HIV Risk Reduction and Drug Abuse Treatment in Iran

A Phase 2 study testing Buprenorphine/Subutex, Naltrexone and Drug counseling in people with Opiate Dependence and HIV Infections, run by Yale University at 2 sites in 2 countries.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

A randomized, double blind clinical trial comparing buprenorphine and naltrexone maintenance treatment when combined with drug abuse and HIV risk reduction counseling (DC-HIV) for heroin and opium addicts in Iran. Read more about this study

Who is it for?
Ages 18 to 65 years, men only
Conditions the study is for
Opiate Dependence, HIV Infections
What is being tested?
Buprenorphine/Subutex, Naltrexone and Drug counseling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
2 sitesin 2 countries
Study dates
Oct 2004to Dec 2008
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 65 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Opioid Dependence

Who cannot join

  • Dependence on alcohol, benzodiazepines or sedatives
  • Suicide or homicide risk
  • Psychotic disorder or major depression
  • Inability to read or understand the protocol or assessment questions
  • Life-threatening or unstable medical problems
  • Greater than 3 times normal liver enzymes (AST, GGT)

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

United States1 site

  • Yale University School of Medicine

    New Haven, Connecticut, 06519

Other trials in United States

Iran1 site

  • Institute for Cognitive Studies

    Tehran

Other trials in Iran

About this study

A randomized, double blind clinical trial comparing buprenorphine and naltrexone maintenance treatment when combined with drug abuse and HIV risk reduction counseling (DC-HIV) for heroin and opium addicts in Iran.

Read the detailed description

This randomized double blind clinical trial compares the efficacy of buprenorphine maintenance treatment (BMT) and naltrexone maintenance treatment (NMT) for recently detoxified opioid dependent patients (N=130; 65 heroin dependent, 65 opium dependent-Specific Aim 1). Manual-guided, HIV risk reduction and drug counseling (DC-HIV) is provided to all patients as the platform psychotherapy. Maintenance treatment is provided for 12 weeks to all patients; patients may also continue to receive maintenance treatment for an additional 12 weeks following the initial treatment period. Primary outcome measures, assessed by twice weekly urine toxicology testing and self-report during the first 12 weeks and monthly during the 12-week extension, include resumption of heroin use, 1 and 3 weeks continuous relapse and reductions in HIV risk behaviors. The project will also evaluate the characteristics of treatment-seeking opioid addicts in Iran (including specific risk behaviors and patterns of HIV risk behaviors; prevalence of psychiatric and other medical comorbidity; and patterns of social, family, vocational, and criminal activity and service needs-Specific Aim 2). This data will be used to revise the DC-HIV manual to address the specific circumstances and risk behaviors of opioid addicts in Iran and to provide data regarding any differential response of opium compared to heroin addicts to BMT or NMT. Finally, the project will also provide clinical training for health professionals and training and mentoring in drug abuse treatment and HIV prevention research to clinical researchers who will continue development, implementation, evaluation and dissemination of HIV prevention and drug abuse treatment approaches in Iran after the project ends (Specific Aim 3). The Institute for Cognitive Science Studies will collaboratively fund the project and lead subsequent dissemination and drug abuse and HIV risk reduction efforts in Iran.

Being tested
Buprenorphine/Subutex, Naltrexone, Drug counseling
Keywords
Buprenorphine, Naltrexone, HIV risk reduction behavior, Counseling, HIV Seronegativity
Medical subject headings
Opioid-Related Disorders, HIV Infections

What participants receive

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

  • Buprenorphine/SubutexDrug

    Also called Subutex

    Opioid agonist medication to treat opiate dependence

  • NaltrexoneDrug

    Opioid antagonist medication to treat opiate dependence

  • Drug counselingBehavioural

    DC-HIV: Drug Counseling that provides education about HIV, drug abuse and dependence; encourages medication adherence; uses motivational enhancement techniques; encourages life style changes; and teaches cognitive and behavioral coping skills to prevent relapse

Study groups in NCT00398008
Study groupRoleWhat they receive
1ExperimentalDC-HIV plus buprenorphine maintenance.
Receives: Drug: Buprenorphine/Subutex; Behavioral: Drug counseling
2ExperimentalDC-HIV plus naltrexone maintenance
Receives: Drug: Naltrexone; Behavioral: Drug counseling

What is being measured

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

  1. Time to resumption of heroin use

    Measured: 26 weeks

  2. Time to relapse

    Measured: 26 weeks

  3. Maximum consecutive weeks of opiate abstinence

    Measured: 26 weeks

  4. Reduction of HIV risks

    Measured: 26 weeks

Secondary outcomes (2)

  1. Addiction-related functional status

    Measured: 26 weeks

  2. Adverse events

    Measured: 26 weeks

Timeline

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

  1. First posted10 Nov 2006 (estimated)
  2. Study startOct 2004
  3. Primary completionDec 2006
  4. Study completionDec 2008 (estimated)

Why it stopped: Study was never able to start in IRAN

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00398008
Sponsor's protocol ID
0207018835
Other IDs
R01DA014718-02S1
Status last verified
Jul 2013
First submitted
9 Nov 2006
Last updated
30 Mar 2020
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Buprenorphine/Subutex, Naltrexone and Drug counseling in people with Opiate Dependence and HIV Infections, run by Yale University at 2 sites in 2 countries.

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 6 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: withdrawn, as of the sponsor's last update on 30 Mar 2020. 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 United States, Iran. 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 was withdrawn before enrolling participants, so there are no results.

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?

Time to resumption of heroin use (time frame: 26 weeks). The study lists 4 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 NCT00398008.

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 30 Mar 2020.

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