Methadone vs Buprenorphine for Opioid Use Disorder
Recruiting in Palo Alto (17 mi)
+5 other locations
Overseen byDavid Fiellin, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Yale University
Must be taking: MOUD
Disqualifiers: Pregnancy, Suicidal, Severe cognitive impairment, others
No Placebo Group
Prior Safety Data
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.
12345Eligibility 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.
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Office-based methadoneExperimental Treatment1 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 Control1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Rapid Start Clinic, Kaiser Permanente ColoradoDenver, CO
Officed Based Addiction Treatment Program, Boston Medical CenterBoston, MA
Hennepin Healthcare Addiction MedicineMinneapolis, MN
Marshall University Division of Addiction Sciences P.R.O.A.C.THuntington, WV
More Trial Locations
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Who Is Running the Clinical Trial?
Yale UniversityLead Sponsor
Kaiser PermanenteCollaborator
National Institutes of Health (NIH)Collaborator
University of California, San FranciscoCollaborator
National Institute on Drug Abuse (NIDA)Collaborator
The Emmes Company, LLCIndustry Sponsor
Boston Medical Center (BMC)Collaborator
Hennepin Healthcare Research InstituteCollaborator
Alameda Health SystemCollaborator
Marshall HealthCollaborator
References
Buprenorphine in the treatment of opiate dependence. [2013]Compelling clinical evidence establishes that buprenorphine is similar to methadone in efficacy for opiate detoxification and maintenance but safer than methadone in an overdose situation. The Drug Abuse Treatment Act of 2000 (DATA 2000) enabled US physicians with additional training to prescribe buprenorphine to a limited number of opiate-dependent patients. The sublingual tablets Subutex (buprenorphine alone) and Suboxone (a combination of buprenorphine and naloxone) meet the specifications of DATA 2000. Suboxone is intended to discourage intravenously administration and has less abuse potential than buprenorphine alone. Suboxone is generally recommended for maintenance treatment except for women who are pregnant. Subutex is recommended in treatment of pregnant women. A buprenorphine opiate withdrawal syndrome can occur in newborns. Although intravenous buprenorphine abuse is a significant public health problem in some countries, buprenorphine alone or in combination with naloxone has less potential for abuse than heroin and some prescription opiates, such as oxycodone. Pharmacotherapy from physicians' offices makes buprenorphine treatment acceptable to some opiate-dependent patients who would not accept treatment in traditional opiate-maintenance clinics. For reasons not adequately understood, some patients find discontinuation of buprenorphine following long-term use difficult. This article reviews the pharmacology of buprenorphine, summarizes evidence supporting the safety and efficacy of buprenorphine and provides clinical guidelines for treatment.
Buprenorphine-based regimens and methadone for the medical management of opioid dependence: selecting the appropriate drug for treatment. [2016]Maintenance therapy with methadone or buprenorphine-based regimens reduces opioid dependence and associated harms. The perception that methadone is more effective than buprenorphine for maintenance treatment has been based on low buprenorphine doses and excessively slow induction regimens used in early buprenorphine trials. Subsequent studies show that the efficacy of buprenorphine sublingual tablet (Subutex®) or buprenorphine/naloxone sublingual tablet (Suboxone®) is equivalent to that of methadone when sufficient buprenorphine doses, rapid induction, and flexible dosing are used. Although methadone remains an essential maintenance therapy option, buprenorphine-based regimens increase access to care and provide safer, more appropriate treatment than methadone for some patients.
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]Buprenorphine/naloxone (BUP-NX) and methadone are used to treat opioid use disorder (OUD), yet there is insufficient evidence on the impact of doses on interventions' effectiveness and safety when treating OUD attributable to other opioids than heroin.
Rapid Transition From Methadone to Buprenorphine Utilizing a Micro-dosing Protocol in the Outpatient Veteran Affairs Setting. [2022]Alternative transition protocols from methadone to buprenorphine in the treatment of opioid use disorder (OUD) are needed to reduce the risk of precipitated withdrawal and opioid use during induction.
Factors associated with retention on medications for opioid use disorder among a cohort of adults seeking treatment in the community. [2022]Medication treatment for opioid use disorder (OUD) (MOUD; buprenorphine and methadone) reduces opioid use and overdose. Discontinuation of MOUD can quickly lead to relapse, overdose and death. Few persons who initiate MOUD are retained on treatment, thus it is critical to identify factors associated with retention.