HIV Risk Reduction and Drug Abuse Treatment in Malaysia

NCT00383045 | Completed Phase 2

• 2 other identifiers: 0103012336R01DA014718-04
• Study Type: interventional
• Target: 180
• Locations: 2 countries
• Sites: 2

Brief Summary

A randomized clinical trial comparing drug abuse and HIV risk reduction counseling (DC-HIV) alone, DC-HIV combined with naltrexone maintenance, and DC-HIV combined with buprenorphine maintenance for the treatment of heroin addicts in Malaysia.

Conditions

Opiate Dependence

Keywords

Buprenorphine; Naltrexone; HIV risk reduction behavior; Counseling

Outcome Measures

Primary Outcomes (4)

• Time to resumption of heroin use

• Time to relapse

• Maximum consecutive weeks of opiate abstinence

• Reduction of HIV risks

Secondary Outcomes (2)

• Addiction-related functional status

• Adverse events

Interventions

Buprenorphine/Subutex DRUG

Naltrexone DRUG

Drug counseling PROCEDURE

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (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)

Sponsors & Collaborators

• Yale University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

Yale University School of Medicine

New Haven, Connecticut, 06519, United States

Location

Substance Abuse Research Center

Muar town, Johor, Malaysia

Location

Related Publications (3)

• Mazlan M, Schottenfeld RS, Chawarski MC. New challenges and opportunities in managing substance abuse in Malaysia. Drug Alcohol Rev. 2006 Sep;25(5):473-8. doi: 10.1080/09595230600883354.

  PMID: 16939945 BACKGROUND

• Chawarski MC, Mazlan M, Schottenfeld RS. Heroin dependence and HIV infection in Malaysia. Drug Alcohol Depend. 2006 Apr;82 Suppl 1:S39-42. doi: 10.1016/s0376-8716(06)80007-4.

  PMID: 16769444 BACKGROUND

• Schottenfeld RS, Chawarski MC, Mazlan M. Maintenance treatment with buprenorphine and naltrexone for heroin dependence in Malaysia: a randomised, double-blind, placebo-controlled trial. Lancet. 2008 Jun 28;371(9631):2192-200. doi: 10.1016/S0140-6736(08)60954-X.

  PMID: 18586174 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Buprenorphine; Naltrexone

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Naloxone

Study Officials

• Richard S. Schottenfeld, M.D.

  Yale University

  PRINCIPAL INVESTIGATOR

• Mahmud Mazlan, M.D.

  Hospital Muar, Malaysia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 28, 2006
• First Posted: October 2, 2006
• Study Start: April 1, 2003
• Study Completion: August 1, 2007
• Last Updated: March 31, 2020

Record last verified: 2009-02

Locations

MY (1); US (1)