Medication-assisted Treatment for Injecting Drug Users in Vietnam

NCT05368675 | Completed Phase 4 DMC

• 1 other identifier: R01DA033671
• Study Type: interventional
• Target: 448
• Locations: 0 countries
• Sites: N/A

Brief Summary

HIV continues to spread around the world and new infections in Asia are one of the most important areas for prevention among drug using populations. There is strong and consistent evidence from several countries that while injection drug users (IDU) continue to be a source of new infections, treatment of opiate addiction is an effective prevention measure against further spread. The project evaluated the implementation of a comprehensive opioid use disorder treatment program co-located with an HIV clinic in Ho Chi Minh City, Vietnam. The program includes medication for opioid use disorder (methadone, buprenorphine/naloxone), standardized counseling sessions (BDRC) and HIV testing and care (for people living with HIV).

Conditions

Opioid Use Disorder; HIV Infections

Keywords

medication for opioid use disorder; HIV care

Outcome Measures

Primary Outcomes (3)

• Retention in treatment program at 12 months

  Percentage of participants who stay in treatment for 12 months

  12 months

• Adherence in treatment program at 12 months

  Missing doses of treatment during time in the study

  12 months

• Cost of 12-month treatment program

  Cost of 12 months of the treatment program evaluated with the Drug Abuse Treatment Cost Analysis Program (DATCAP)

  12 months

Secondary Outcomes (2)

• Change in substance use from baseline to 12-month follow-up

  12 months

• Viral load suppression for people living with HIV

  12 months

Interventions

medication for opioid use disorder DRUG

This is an open-label study. The project proposes to enroll up to 500 opiate dependent individuals entering Medication Assisted Treatment (Methadone or buprenorphine/naloxone) at Go Vap Clinic, HCMC, Vietnam. All participants who appear to meet inclusion criteria and who express interest in drug treatment will be invited to be screened for participation in the research. All participants will receive BDRC sessions (weekly for 12 weeks, monthly thereafter until week 52).

Also known as: methadone, buprenorphine/naloxone, Behavioral Drug and Risk Counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 18 or more years of age
• Meets DSM-5 criteria for opiate use disorder
• Positive urine drug screen for heroin or other opiates
• Interested in methadone maintenance or Suboxone® treatment for opiate use disorder
• Injected heroin within past 30 days by self-report, documented by "tracks" or puncture marks
• Willingness and ability to give informed consent and otherwise participate
• Provision of adequate locator information

You may not qualify if:

• Clinically significant cognitive impairment, schizophrenia, paranoid disorder, bipolar disorder
• Known neurological, cardiovascular, renal, or other medical disorder that is likely to impair or make the patient's participation hazardous
• Physiologically dependent on alcohol, benzodiazepines, or other sedative type drugs
• Pending legal charges with likely incarceration within next 12 months

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute of Drug Abuse: collaborator
• Expertise France: collaborator

MeSH Terms

Conditions

Opioid-Related Disorders; HIV Infections

Interventions

Dosage Forms; Methadone; Buprenorphine, Naloxone Drug Combination

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques; Ketones; Organic Chemicals; Buprenorphine; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Naloxone; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Drug Combinations

Study Officials

• Charles P O'Brien, MD, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2022
• First Posted: May 10, 2022
• Study Start: December 18, 2013
• Primary Completion: August 31, 2017
• Study Completion: August 31, 2018
• Last Updated: May 10, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share