Methadone vs Buprenorphine for Opioid Use Disorder

Recruiting at 5 trial locations

Overseen By Ingrid Binswanger, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Yale University

Must be taking: MOUD

Disqualifiers: Pregnancy, Suicidal, Severe cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

600 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this clinical trial is to compare the effectiveness of office-based methadone with pharmacy administration and/or dispensing to office-based buprenorphine for the treatment of opioid use disorder. This study will also examine factors influencing the implementation of office-based methadone.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you have been on certain opioid treatments for more than 72 hours in the past week, you may not be eligible to participate.

How do methadone and buprenorphine differ from other drugs for opioid use disorder?

Methadone and buprenorphine are unique in treating opioid use disorder because they both reduce opioid dependence and associated harms, but buprenorphine is considered safer in overdose situations. Buprenorphine can be prescribed by trained physicians outside of traditional clinics, making it more accessible, and it has less potential for abuse compared to methadone and other opioids. ^{1 2 3 4 5}

Research Team

David Fiellin, MD

Principal Investigator

Yale University

Eligibility Criteria

This trial is for adults over 18 who meet the criteria for Opioid Use Disorder (OUD) according to the DSM-5 and are starting a new medication treatment. Specific details on who can't join were not provided.

Inclusion Criteria

I am 18 years old or older.

I have been diagnosed with opioid use disorder.

I am starting a new medication treatment for opioid use disorder.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either office-based methadone or buprenorphine for opioid use disorder treatment, with additional behavioral treatments offered

24 weeks

Regular visits for medication administration and behavioral treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Buprenorphine
• Methadone

Trial Overview The study compares two treatments for opioid addiction: methadone given at doctors' offices versus buprenorphine (BUP). It also looks into how well office-based methadone programs work.

Participant Groups

Group I: Office-based methadone Experimental Treatment 1 Intervention

Under special Drug Enforcement Administration (DEA) exception, Clinician prescribes methadone and oral methadone is administered and/or dispensed at a pharmacy which also has an exception to do so. All randomized controlled trial (RCT) participants are offered additional behavioral treatments (e.g., individual, group, telehealth, phone-based).

Group II: Office-based buprenorphine (BUP) Active Control 1 Intervention

Clinician prescribes BUP formulations that are dispensed at a pharmacy or administered in the office (e.g., extended-release formulations). All RCT participants are offered additional behavioral treatments (e.g., individual, group, telehealth, phone-based).

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

Approved in United States as Buprenorphine for:

• Moderate to severe opioid addiction (dependence)

Approved in European Union as Buprenorphine for:

• Opioid dependence

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Kaiser Permanente

Collaborator

Trials

563

Recruited

27,400,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

University of California, San Francisco

Collaborator

Trials

2,636

Recruited

19,080,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

The Emmes Company, LLC

Industry Sponsor

Trials

149

Recruited

1,052,000+

Peter Ronco

The Emmes Company, LLC

Chief Executive Officer since 2023

BSc from Nottingham University

Dr. Joe Sliman

The Emmes Company, LLC

Chief Medical Officer since 2020

MD from Uniformed Services University of the Health Sciences, MPH from Johns Hopkins University, BSc in Molecular and Cell Biology from Pennsylvania State University

Boston Medical Center (BMC)

Collaborator

Trials

1

Recruited

600+

Hennepin Healthcare Research Institute

Collaborator

Trials

94

Recruited

77,100+

Alameda Health System

Collaborator

Trials

9

Recruited

4,100+

Marshall Health

Collaborator

Trials

1

Recruited

600+

Findings from Research

Buprenorphine is as effective as methadone for opiate detoxification and maintenance but is safer in overdose situations, making it a preferable option for treatment.

Suboxone, a combination of buprenorphine and naloxone, is recommended for maintenance treatment due to its lower abuse potential, while Subutex (buprenorphine alone) is advised for pregnant women, highlighting the tailored approach to treatment based on patient needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Buprenorphine in the treatment of opiate dependence. Wesson, DR., Smith, DE.[2013]

Recent studies indicate that buprenorphine, when administered at adequate doses and with rapid induction, is as effective as methadone for maintaining treatment in opioid dependence, challenging previous perceptions of its efficacy.

Buprenorphine-based regimens not only enhance access to treatment but also offer a safer alternative for certain patients compared to methadone, making it a valuable option in opioid dependence therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Buprenorphine-based regimens and methadone for the medical management of opioid dependence: selecting the appropriate drug for treatment. Maremmani, I., Gerra, G.[2016]

In a study involving 272 participants with opioid use disorder primarily using opioids other than heroin, higher doses of methadone were associated with better retention in treatment, suggesting that its full µ-opioid receptor agonism may enhance treatment adherence.

In contrast, the doses of buprenorphine/naloxone did not show a significant association with treatment retention or adverse events, indicating that while both treatments are used, methadone may be more effective for keeping patients in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Associations of methadone and buprenorphine-naloxone doses with unregulated opioid use, treatment retention, and adverse events in prescription-type opioid use disorders: Exploratory analyses of the OPTIMA study. Bakouni, H., McAnulty, C., Tatar, O., et al.[2023]

A case report involving one patient showed that a rapid microinduction protocol for transitioning from methadone to buprenorphine was successful without causing precipitated withdrawal, indicating a safer method for patients with opioid use disorder.

This outpatient approach not only proved feasible but also cost-effective, suggesting it could help reduce barriers to adherence in opioid agonist therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapid Transition From Methadone to Buprenorphine Utilizing a Micro-dosing Protocol in the Outpatient Veteran Affairs Setting. De Aquino, JP., Fairgrieve, C., Klaire, S., et al.[2022]

In a study of 118 adults with moderate to severe opioid use disorder, higher doses of medication for opioid use disorder (MOUD) significantly improved retention rates, with an odds ratio of 4.71 for those on high doses.

Participants experiencing higher levels of pain interference were also more likely to remain on MOUD, suggesting that effective pain management may enhance treatment retention and provide dual benefits for both opioid use disorder and pain relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors associated with retention on medications for opioid use disorder among a cohort of adults seeking treatment in the community. Biondi, BE., Vander Wyk, B., Schlossberg, EF., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Buprenorphine in the treatment of opiate dependence. [2013]

2. England pubmed.ncbi.nlm.nih.gov

Buprenorphine-based regimens and methadone for the medical management of opioid dependence: selecting the appropriate drug for treatment. [2016]

3. England pubmed.ncbi.nlm.nih.gov

Associations of methadone and buprenorphine-naloxone doses with unregulated opioid use, treatment retention, and adverse events in prescription-type opioid use disorders: Exploratory analyses of the OPTIMA study. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Rapid Transition From Methadone to Buprenorphine Utilizing a Micro-dosing Protocol in the Outpatient Veteran Affairs Setting. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Factors associated with retention on medications for opioid use disorder among a cohort of adults seeking treatment in the community. [2022]