Medication-Assisted Therapies for Opioid Use Disorder
(ExMAT CA Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
Central Asia (CA) represents the most rapidly growing HIV epidemic region worldwide, concentrated in people who inject drugs (PWID) and their sexual partners, and scaling up opioid agonist therapies (OAT) in this region is the most cost-effective strategy to prevent new HIV infections, and more effective when combined with antiretroviral therapy (ART). The investigators propose to use the Network for the Improvement of Addiction Treatment (NIATx) implementation strategy to scale-up OAT in three diverse Central Asian countries (Kazakhstan, Kyrgyzstan, Tajikistan) and guided by the Exploration-Planning-Implementation-Sustainment (EPIS) framework. Understanding the trajectories of implementation and scale-up in this context may emerge through creating communities of practice, especially when cohesion and competence evolves, and may guide other healthcare delivery challenges in the region (e.g., HIV, TB); as well as build important regional expertise and understanding implementation trajectories should help support OAT program sustainability.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It focuses on opioid agonist therapies, so it's best to discuss your current medications with the trial coordinators.
Is medication-assisted therapy for opioid use disorder safe?
Buprenorphine (Subutex) is generally considered safe for treating opioid dependence, especially when combined with naloxone (Suboxone), but there are risks if misused, such as severe complications from injecting the medication. It has a low potential for abuse when used correctly, and the risk of overdose is reduced compared to other treatments.12345
How is the drug NIATx (Subutex, Suboxone, Temgesic) unique in treating opioid use disorder?
NIATx, which includes Subutex and Suboxone, is unique because it combines buprenorphine, a partial mu-opioid receptor agonist, with naloxone to reduce abuse potential, and can be prescribed by certified physicians in an office setting, increasing access to treatment compared to traditional methadone programs.35678
What data supports the effectiveness of the drug Suboxone for opioid use disorder?
Suboxone is considered one of the more effective treatments for opioid use disorder, as it helps reduce illicit opioid use and retain patients in treatment. Clinical studies have shown that buprenorphine, a component of Suboxone, is as effective as methadone in maintaining patients in substance abuse treatment.910111213
Who Is on the Research Team?
Frederick L Altice, MD
Principal Investigator
Yale University
Are You a Good Fit for This Trial?
This trial is for adults with opioid dependence in Central Asia, specifically those who inject drugs and are either new to opioid agonist therapy (OAT) or have been on OAT for less than 90 days. It includes both individuals seeking treatment and professionals involved in delivering OAT.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Exploration/Preparation
Assess barriers and facilitators to OAT scale-up, including inner and outer context and bridging factors associated with OAT innovations
Implementation
Training in-country coaches and using a menu of tools and quality improvement techniques to scale-up OAT
Sustainment
Convene stakeholder meetings to guide implementation and inform policies for expanding OAT
Follow-up
Participants are monitored for sustainability and effectiveness of OAT scale-up
What Are the Treatments Tested in This Trial?
Interventions
- NIATx
NIATx is already approved in European Union, United States, Canada for the following indications:
- Opioid dependence
- Chronic pain
- Opioid dependence
- Chronic pain
- Opioid dependence
Find a Clinic Near You
Who Is Running the Clinical Trial?
Yale University
Lead Sponsor
Den Sooluk Nuru
Collaborator
Global Health Research Center of Central Asia
Collaborator
AIDS Foundation East-West (AFEW) Kyrgyzstan
Collaborator
Institute for International Health and Education
Collaborator
Columbia University Global Health Research Center of Central Asia
Collaborator
National Institute on Drug Abuse (NIDA)
Collaborator