Medication Assisted Treatment for Opioid Addiction

(HOMER Trial)

Recruiting at 1 trial location

Overseen By Donald E Nease, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Must be taking: Buprenorphine, Suboxone

Disqualifiers: Hypersensitivity, High AST/ALT, Untreated psychiatric, others

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

Compensation: Varies

Number of Visits: 1

303 Participants Needed

Trial Summary

What is the purpose of this trial?

HOMER is a national study comparing three methods of induction for Medication Assisted Treatment (MAT) for Opioid Use Disorder (OUD); home versus office versus telehealth-based inductions. This study will help determine if certain patient and practice characteristics make patients better candidates for one method over the others. Results will help fill a gap in the evidence around effectively treating OUD with MAT in primary care settings.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, since the study involves starting medication-assisted treatment for opioid addiction, it's best to discuss your current medications with the trial team to ensure there are no interactions.

What data supports the effectiveness of the drug used in Medication Assisted Treatment for opioid addiction?

Research shows that Medication Assisted Treatment (MAT) for opioid use disorder is more effective than traditional methods like counseling alone. It helps save lives and improve the quality of life for those in recovery, with medications like methadone and buprenorphine being particularly effective when combined with counseling. ^{1 2 3 4 5}

Is medication-assisted treatment for opioid addiction safe for humans?

Medication-assisted treatment for opioid addiction, including methadone and buprenorphine, is generally considered safe when used correctly, but there are risks of overdose and death, especially during the early stages of treatment. Long-acting naltrexone is also used and is generally safe, but it requires monitoring for liver issues and has an increased risk of overdose if opioids are used during or after treatment. ^{6 7 8 9 10}

How is medication-assisted treatment for opioid addiction different from other treatments?

Medication-assisted treatment (MAT) for opioid addiction is unique because it combines medications like methadone, buprenorphine, or naltrexone with counseling and behavioral therapies, which significantly improve outcomes compared to psychosocial treatment alone. MAT helps reduce opioid use, retain patients in treatment, and prevent overdose, making it more effective than treatments without medication. ^{2 6 8 11 12}

Eligibility Criteria

This trial is for individuals aged 16 or older with opioid dependence, either due to addiction as per DSM-V criteria or chronic pain with long-term high-dose opioid use. Participants must be willing to complete surveys over nine months and accept random assignment to one of three Medication Assisted Treatment (MAT) induction methods: home, office, or telehealth.

Inclusion Criteria

I am 16 or older with opioid dependence due to addiction or long-term, high-dose use for chronic pain.

Agree to answer a set of survey questions four times over a nine month period (at the time of enrollment plus 1, 3, and 9 months after starting treatment.

I am willing to take buprenorphine or Suboxone for treatment.

Exclusion Criteria

You are allergic to buprenorphine or naloxone.

Are known to have serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels greater than five times normal.

I prefer a specific medication-assisted treatment for addiction and do not want to be randomly assigned.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction

Participants undergo induction for Medication Assisted Treatment (MAT) for Opioid Use Disorder (OUD) using home, office, or telehealth methods

1 week

1 visit (in-person or telehealth)

Short-term Stabilization

Participants are monitored for short-term stabilization after induction

4 weeks

Long-term Maintenance

Participants continue with long-term maintenance treatment and are monitored for outcomes

270 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Medication Assisted Treatment

Trial Overview The HOMER study is testing whether home-based, office-based, or telehealth-based inductions are most effective for starting MAT in patients with Opioid Use Disorder. It aims to identify which patient characteristics might favor a particular method in primary care settings.

Participant Groups

Group I: Home Active Control 1 Intervention

This induction arm is asynchronous and unobserved. The home induction is done primarily by the participant in their home or current residence. The participant receives instruction on induction process from clinic team at an in-person or telehealth visit. Home induction is initiated by the participant at a time and place (other than the practice) determined by the participant. The participant determines when to stop taking opioids, begins withdrawal, monitors symptoms, administers the SOWS, and determines when to take first dose of medication, per the instructions and protocol provided. The clinic team does not observe or have contact with the participant while the participant undergoes these steps or takes the first dose. The participant continues this process for additional doses. Follow-up contact with clinic team may occur after the first or second day, typically within a week.

Group II: Office Active Control 1 Intervention

This induction arm is synchronous and observed by the clinical team. The participant receives instruction from clinic team at an in-person or telehealth visit. On a pre-determined day, the participant stops taking opioids and comes to office with mild to moderate withdrawal. The clinic team monitors the participant, assesses symptoms, administers COWS to determine time of first dose of medication, and administers first dose with the participant. The clinic team observes and has in-person contact with the participant. Office induction includes the observed administration of the first dose, followed by observation and evaluation 30-60 minutes after the first dose. After 30-60 minutes of observation, the clinic team and participant decide whether to administer the second dose in the office or for the participant to leave the clinic to administer subsequent doses. On rare occasions, a second dose may not be needed (if the participant has a low COWS score after just one dose).

Group III: Telehealth Active Control 1 Intervention

This induction arm is synchronous via phone or video contact and observed. The participant receives instruction on induction process from clinic team at an in-person or telehealth visit. The participant undergoes the same process as an office induction but from a location other than the clinic. Like an office induction, the participant has regular contact with someone from the practice team on Day 1 of induction. Prior to initiating the first dose, the participant has contact by phone or video with the clinic team to assess symptoms and determine level of withdrawal (using COWS or SOWS). The administration of the first dose of medication is determine by the clinic team during phone or video contact, and the clinic team is in contact with the participant by phone or video when the first dose is taken. This process continues through the second and possible third dose. The participant is re-assessed via video or phone regularly by clinic staff and prescriber throughout this process.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

American Academy of Family Physicians National Research Network

Collaborator

Trials

8

Recruited

50,500+

Findings from Research

A study involving 225 participants from medication-assisted treatment (MAT) programs in West Virginia highlighted that most individuals currently in MAT prefer personalized treatment plans and shared decision-making with their healthcare providers.

Participants expressed mixed opinions on policies regarding the duration of MAT, use of marijuana or anti-anxiety medications during treatment, and attendance in peer recovery groups, indicating the need for flexible and individualized approaches to support retention in MAT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medication Assisted Treatment Program Policies: Opinions of People in Treatment. Carter, M., Boyd, J., Bennett, T., et al.[2023]

Medications for opioid use disorders, such as methadone and buprenorphine, have significantly improved treatment outcomes compared to psychosocial treatment alone, especially for individuals with severe disorders.

The effectiveness of these medications is enhanced when combined with counseling and other support services, and there is growing evidence supporting supervised heroin injecting for those who do not respond to standard treatments, as seen in studies from Switzerland and other countries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in the treatment of opioid use disorders. Woody, GE.[2019]

Methadone is a safe and effective treatment for addiction and chronic pain, but there are elevated risks of overdose and death, particularly during the initial phases of treatment.

The consensus statement developed by experts emphasizes the importance of careful dose management and patient education to reduce the risks associated with methadone induction and stabilization, which can ultimately save lives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safe methadone induction and stabilization: report of an expert panel. Baxter, LE., Campbell, A., Deshields, M., et al.[2013]

Extended-release injectable naltrexone has been approved for treating opioid dependence, showing increased treatment adherence compared to oral formulations, which often suffer from poor compliance and relapse.

While long-acting naltrexone is effective, it requires monitoring for potential liver damage and patients must be cautioned about the heightened risk of overdose if they use opioids during or shortly after stopping the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-acting injectable naltrexone for the management of patients with opioid dependence. Kjome, KL., Moeller, FG.[2021]

References

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

Medication Assisted Treatment Program Policies: Opinions of People in Treatment. [2023]

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

Advances in the treatment of opioid use disorders. [2019]

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

Identifying patient-important outcomes in medication-assisted treatment for opioid use disorder patients: a systematic review protocol. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Intent to Refer: Exploring Bias Toward Specific Medication-Assisted Treatments by Community Corrections Employees. [2019]

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

Buprenorphine to treat opioid use disorder: A practical guide. [2019]

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

Medication-assisted treatment of opioid use disorder: review of the evidence and future directions. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Safe methadone induction and stabilization: report of an expert panel. [2013]

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

Screaming Behind a Door: The Experiences of Individuals Incarcerated Without Medication-Assisted Treatment. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Too much or never enough: a response to Treatment of opioid disorders in Canada: looking at the 'other epidemic'. [2018]

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

Long-acting injectable naltrexone for the management of patients with opioid dependence. [2021]

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

Association between opioid analgesic therapy and initiation of buprenorphine management: An analysis of prescription drug monitoring program data. [2020]

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

Perceived Ability to Treat Opioid Use Disorder in West Virginia. [2022]