900 Participants Needed

Medication-Assisted Therapies for Opioid Use Disorder

(ExMAT CA Trial)

Recruiting at 4 trial locations
FL
Overseen ByFrederick L Altice, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Yale University
Must be taking: Opioid agonist therapies
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 4 JurisdictionsThis treatment is already approved in other countries

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?

FL

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

I am 18 or older with opioid dependence, new to treatment or on treatment for less than 90 days.
I am over 18 and a Chief Narcologist at an Oblast level.
I am over 18 and work in opioid addiction treatment.
See 3 more

Exclusion Criteria

Not willing to provide consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Exploration/Preparation

Assess barriers and facilitators to OAT scale-up, including inner and outer context and bridging factors associated with OAT innovations

6 months

Implementation

Training in-country coaches and using a menu of tools and quality improvement techniques to scale-up OAT

12 months

Sustainment

Convene stakeholder meetings to guide implementation and inform policies for expanding OAT

18 months

Follow-up

Participants are monitored for sustainability and effectiveness of OAT scale-up

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • NIATx
Trial Overview The study tests the NIATx strategy, aiming to expand OAT programs effectively across Kazakhstan, Kyrgyzstan, and Tajikistan. The goal is to prevent HIV among people who inject drugs by improving addiction treatments using the EPIS framework.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: NIATx ModelExperimental Treatment1 Intervention
Receiving NIATx Coaching

NIATx is already approved in European Union, United States, Canada for the following indications:

πŸ‡ͺπŸ‡Ί
Approved in European Union as Subutex for:
  • Opioid dependence
  • Chronic pain
πŸ‡ΊπŸ‡Έ
Approved in United States as Suboxone for:
  • Opioid dependence
πŸ‡¨πŸ‡¦
Approved in Canada as Temgesic for:
  • Chronic pain
  • Opioid dependence

Find a Clinic Near You

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials
1,963
Recruited
3,046,000+

Den Sooluk Nuru

Collaborator

Trials
1
Recruited
900+

Global Health Research Center of Central Asia

Collaborator

Trials
1
Recruited
900+

AIDS Foundation East-West (AFEW) Kyrgyzstan

Collaborator

Trials
1
Recruited
900+

Institute for International Health and Education

Collaborator

Trials
1
Recruited
900+

Columbia University Global Health Research Center of Central Asia

Collaborator

Trials
1
Recruited
900+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials
2,658
Recruited
3,409,000+

Published Research Related to This Trial

The RDD study, one of the largest clinical trials for opioid use disorder (OUD), will evaluate different dosing strategies of buprenorphine and the impact of a digital therapeutic app on treatment retention, addressing the significant issue of poor retention rates in current OUD treatments.
The trial will also explore tapering strategies for buprenorphine in patients in stable remission, aiming to identify effective methods for safely discontinuing medication while minimizing relapse, which is crucial for long-term recovery.
Prior National Drug Abuse Treatment Clinical Trials Network (CTN) opioid use disorder trials as background and rationale for NIDA CTN-0100 "optimizing retention, duration and discontinuation strategies for opioid use disorder pharmacotherapy (RDD)".Shulman, M., Weiss, R., Rotrosen, J., et al.[2021]
After three years of buprenorphine's approval for office-based treatment of opioid addiction, nearly 90% of addiction specialists were authorized to prescribe it, with two-thirds actively treating patients, indicating strong adoption among specialists.
In contrast, fewer than 10% of non-addiction specialist psychiatrists prescribed buprenorphine, highlighting a significant gap in treatment access and suggesting that organizational support and training are crucial for expanding its use beyond addiction specialists.
Use of buprenorphine for addiction treatment: perspectives of addiction specialists and general psychiatrists.Thomas, CP., Reif, S., Haq, S., et al.[2021]
The Drug Abuse Treatment Act of 2000 (DATA) expanded treatment options for opioid addiction by allowing certified physicians to prescribe buprenorphine in office settings, increasing access to care.
Clinical studies show that buprenorphine is as effective as methadone for maintaining treatment and reducing illicit opioid use, and it is more effective than clonidine for short-term detoxification, highlighting its role as a valuable tool in addiction treatment.
Bupreorphine:a new pharmacotherapy for opioid addictions treatment.Stock, C., Shum, JH.[2013]

Citations

Prior National Drug Abuse Treatment Clinical Trials Network (CTN) opioid use disorder trials as background and rationale for NIDA CTN-0100 "optimizing retention, duration and discontinuation strategies for opioid use disorder pharmacotherapy (RDD)". [2021]
Use of buprenorphine for addiction treatment: perspectives of addiction specialists and general psychiatrists. [2021]
Bupreorphine:a new pharmacotherapy for opioid addictions treatment. [2013]
Smartphone intervention to optimize medication assisted treatment outcomes for opioid use disorder: study protocol for a randomized controlled trial. [2023]
Smartphone intervention to optimize medication-assisted treatment outcomes for opioid use disorder: study protocol for a randomized controlled trial. [2023]
Naltrexone extended-release injection: an option for the management of opioid abuse. [2021]
Groin tissue necrosis requiring skin graft following parenteral abuse of buprenorphine tablets. [2013]
Buprenorphine maintenance: a new treatment for opioid dependence. [2019]
Severe upper limb complications from parenteral abuse of Subutex. [2020]
10.United Statespubmed.ncbi.nlm.nih.gov
Can the chronic administration of the combination of buprenorphine and naloxone block dopaminergic activity causing anti-reward and relapse potential? [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
Anesthesia for patients on buprenorphine. [2013]
12.United Statespubmed.ncbi.nlm.nih.gov
Medications for substance use disorders. [2021]
13.United Statespubmed.ncbi.nlm.nih.gov
Buprenorphine: a (relatively) new treatment for opioid dependence. [2021]
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