Methadone for Addiction

Overseen By Kyle Kampman, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Pennsylvania

Must not be taking: Buprenorphine, Benzodiazepines, Alcohol, others

Disqualifiers: Pregnancy, Cardiac issues, Hepatic dysfunction, others

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

Compensation: Varies

Number of Visits: 2

Duration: 2 days

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for initiating methadone treatment in individuals with opioid use disorder who also use fentanyl. Researchers aim to determine if a higher initial dose, known as a loading dose, proves more effective than the standard approach. Participants will be randomly assigned to either the standard or loading dose group. Suitable candidates include those with opioid use disorder involving fentanyl use who are interested in starting methadone treatment at specified locations. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new approach.

Will I have to stop taking my current medications?

The trial requires that you stop taking medications for opioid use disorder, as well as certain medications that affect heart rhythm or interact with methadone. If you're taking any of these, you may need to stop before joining the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that methadone is generally well-tolerated for treating opioid use disorder. One study found that patients who began with a 30 mg dose and increased to 60 mg experienced few serious side effects. This finding suggests that methadone can be safely initiated at these doses under medical supervision.

The FDA has approved methadone for treating opioid use disorder, indicating it has been tested for safety in people. However, like all opioids, methadone carries some risks, including the potential for addiction and misuse.

In summary, methadone is considered safe when used correctly, but monitoring for side effects is important, especially with higher doses or larger initial doses. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for fentanyl OUD?

Methadone is unique because it offers a different approach to managing addiction. Most treatments for opioid addiction, like buprenorphine or naltrexone, focus on reducing cravings or blocking opioid effects. However, methadone works by stabilizing the patient and reducing withdrawal symptoms through a full opioid agonist effect, which can help individuals maintain normal lives. Researchers are excited about the potential for a loading dose strategy, which could lead to faster stabilization for patients, reducing the time it takes to reach an effective maintenance dose. This method could make it easier for patients to stick with their treatment plans, offering a smoother transition to recovery.

What evidence suggests that this trial's treatments could be effective for fentanyl OUD?

Research has shown that methadone effectively treats opioid use disorder (OUD), even when fentanyl is involved. In this trial, participants will receive either a treatment-as-usual (TAU) regimen with moderate doses of methadone or a loading dose regimen with higher initial doses. Studies have found that both moderate and high doses of methadone reduce the use of illegal opioids. Methadone users for OUD often stay in treatment longer and experience fewer health problems. Higher doses of methadone correlate with better treatment outcomes, suggesting that starting with a higher dose might be beneficial. Overall, methadone is a well-supported option for reducing opioid use and improving health in people with OUD. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with opioid use disorder due to fentanyl, who can consent in English and follow the study plan. They must be generally healthy, able to take oral meds, and women must not be pregnant. Participants should want to start methadone treatment.

Inclusion Criteria

I am 18 years old or older.

I am willing to follow all study rules and be available for its duration.

I can take pills and will follow the prescribed schedule.

Exclusion Criteria

I regularly take medication that affects liver enzyme levels.

Documented hypersensitivity or allergy to methadone

Pregnancy or actively lactating

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive methadone initiation with either standard or loading dose approach

2 days

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Methadone

Trial Overview The study tests a new way of starting methadone treatment using different initial doses. It's a blinded dose-finding study with participants randomly assigned to standard or loading dose initiation at one of four levels.

How Is the Trial Designed?

Group I: Loading Dose Experimental Treatment 1 Intervention

Day 1: loading dose (60mg, 80mg, 100mg, or 120mg oral methadone) Day 2: 50% of the loading dose (30mg, 40mg, 50, or 60mg oral methadone)

Group II: Treatment as usual (TAU) Active Control 1 Intervention

Day 1: 40mg oral methadone Day 2: 40mg oral methadone

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Citations

1. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/189103

Moderate- vs High-Dose Methadone in the Treatment of ... Results show that both doses of methadone were effective in maintaining patients in treatment and substantially decreasing rates of illicit opioid use.

2. nida.nih.gov nida.nih.gov/research-topics/medications-opioid-use-disorder

Medications for Opioid Use Disorder - Nida.nih.gov Research has shown that methadone, buprenorphine, and naltrexone can reduce opioid use and other negative health outcomes. For example: People ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2772632024000485

Effectiveness of take-home methadone treatment among ... This study critically evaluates the efficacy of take-home methadone for patients with opioid use disorders (OUDs) during public health emergencies.

4. psychiatryonline.org psychiatryonline.org/doi/10.1176/appi.ps.201300235

Medication-Assisted Treatment With Methadone Two systematic reviews suggested that higher doses of methadone were associated with improved outcomes. First, Faggiano and colleagues (23) performed a ...

5. acpjournals.org acpjournals.org/doi/10.7326/M14-2559

The Effectiveness and Risks of Long-Term Opioid Therapy ... Accumulating evidence supports the increased risk for serious harms associated with long-term opioid therapy, including overdose, opioid abuse, fractures, ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK562216/

Methadone - StatPearls - NCBI Bookshelf - NIH Addiction, abuse, and misuse of the drug: The FDA warns that methadone injection injection poses risks of opioid addiction, abuse, and misuse, ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2949875923000541

Safety of rapid inpatient methadone initiation protocol We found that hospitalized patients initiating methadone at 30 mg and increasing by 10 mg daily until 60 mg experienced few serious adverse outcomes.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06877858

NCT06877858 | MethaLoad Dose-Finding Study The goal of this study is to develop a loading dose approach to starting methadone to treat opioid use disorder with fentanyl use ("fentanyl OUD", herein).

9. pew.org pew.org/en/research-and-analysis/fact-sheets/2020/12/medications-for-opioid-use-disorder-improve-patient-outcomes

Medications for Opioid Use Disorder Improve Patient ... Methadone and buprenorphine have also been shown to reduce the risk of death from opioid overdose. (See Table 2.) Additionally, by reducing ...