Brief 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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Timeline

Completed

Started Oct 2004

Typical duration for phase_2

Geographic Reach

2 countries

2 active sites

Status

withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.2 years study duration

Study Start

First participant enrolled

October 1, 2004

Completed

2.1 years until next milestone

First Submitted

Initial submission to the registry

November 9, 2006

Completed

1 day until next milestone

First Posted

Study publicly available on registry

November 10, 2006

Completed

21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed

2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed

Last Updated

March 30, 2020

Status Verified

July 1, 2013

Enrollment Period

2.2 years

First QC Date

November 9, 2006

Last Update Submit

March 27, 2020

Conditions

Opiate Dependence HIV Infections

Keywords

BuprenorphineNaltrexoneHIV risk reduction behaviorCounselingHIV Seronegativity

Outcome Measures

Primary Outcomes (4)

Time to resumption of heroin use
26 weeks
Time to relapse
26 weeks
Maximum consecutive weeks of opiate abstinence
26 weeks
Reduction of HIV risks
26 weeks

Secondary Outcomes (2)

Addiction-related functional status
26 weeks
Adverse events
26 weeks

Study Arms (2)

1

EXPERIMENTAL

DC-HIV plus buprenorphine maintenance.

Drug: Buprenorphine/SubutexBehavioral: Drug counseling

2

EXPERIMENTAL

DC-HIV plus naltrexone maintenance

Drug: NaltrexoneBehavioral: Drug counseling

Interventions

Buprenorphine/SubutexDRUG

Opioid agonist medication to treat opiate dependence

Also known as: Subutex

NaltrexoneDRUG

Opioid antagonist medication to treat opiate dependence

Drug counselingBEHAVIORAL

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

Eligibility Criteria

Age18 Years - 65 Years

Sexmale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Opioid Dependence

You may not qualify if:

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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Yale Universitylead
National Institute on Drug Abuse (NIDA)collaborator

Study Sites (2)

Yale University School of Medicine

New Haven, Connecticut, 06519, United States

Location

Institute for Cognitive Studies

Tehran, Iran

Location

MeSH Terms

Conditions

Opioid-Related DisordersHIV Infections

Interventions

BuprenorphineNaltrexone

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

MorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsNaloxone

Study Officials

Richard S. Schottenfeld, M.D.
Yale University
PRINCIPAL INVESTIGATOR
Azarakhsh Mokri, M.D.
Rouzbeh Hospital, Tehran, Iran
STUDY DIRECTOR

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

November 9, 2006

First Posted

November 10, 2006

Study Start

October 1, 2004

Primary Completion

December 1, 2006

Study Completion

December 1, 2008

Last Updated

March 30, 2020

Record last verified: 2013-07

Locations

IR(1)US(1)

Study Stopped

HIV Risk Reduction and Drug Abuse Treatment in Iran

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (2)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (2)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations