Medication Assisted Treatment for Opioid Addiction

(HOMER Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best way to start Medication Assisted Treatment (MAT) for individuals with Opioid Use Disorder (OUD). It compares three methods: starting treatment at home, in a doctor's office, or through telehealth (phone or video). The study aims to determine which approach works best for different patients. Individuals who have used opioids for over a year and wish to start MAT might be suitable for this trial. Participants will be randomly assigned to a method and will share their experiences over nine months. As an unphased trial, this study offers a unique opportunity to contribute to understanding the most effective ways to begin MAT for diverse patient needs.

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 prior data suggests that these methods of induction for Medication Assisted Treatment are safe for opioid use disorder?

Research shows that Medication Assisted Treatment (MAT) for opioid use disorder is generally safe. Studies indicate that MAT can reduce illegal opioid use and improve daily functioning. People using MAT often remain in treatment longer than those not using medication, suggesting it is well-tolerated.

The U.S. Food and Drug Administration (FDA) has approved these medications for treating opioid use disorder, reinforcing their safety. These treatments help lower the risk of overdose and other dangerous behaviors, such as sharing needles, which can lead to infections.

Overall, MAT is considered a safe option for treating opioid addiction. For those considering joining a study, this information suggests that the treatment should be well-tolerated and effective. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores new ways to deliver Medication Assisted Treatment (MAT) for opioid addiction, focusing on flexibility and accessibility. Unlike traditional in-clinic methods that require direct supervision, this trial includes a home induction arm where participants manage their own treatment process at home, guided by instructions from the clinic. This approach could empower patients by giving them more control and making it easier to start treatment without the need for frequent clinic visits. Additionally, the telehealth arm allows for remote monitoring via phone or video, combining the convenience of home induction with professional oversight. By comparing these different methods, researchers hope to find out which delivery method is most effective and convenient, potentially transforming how MAT is accessed and administered.

What evidence suggests that this trial's methods of induction for Medication Assisted Treatment could be effective for Opioid Use Disorder?

Studies have shown that Medication Assisted Treatment (MAT) for opioid use disorder reduces drug use and improves daily life. Research indicates that treatments like buprenorphine and methadone lower overdose risk and reduce the need for serious medical care. In this trial, participants may start MAT at home, which has been linked to positive outcomes, such as reduced heroin use and improved mental health. Alternatively, participants may begin treatment in a clinic, a well-established method with methadone's success supported by past research. Another option in this trial is starting treatment through telehealth, which offers similar benefits to in-person care and provides a flexible option for many. Overall, MAT effectively manages opioid addiction. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8389722/

Medication Assisted Treatment for Opioid Use Disorder MAT has been shown to improve life functioning and decrease heroin and other opioid use; criminal behavior; drug use practices, such as needle sharing, that ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04664062

Comparing Home, Office, and Telehealth Induction for ... HOMER is a national study comparing three methods of induction for Medication Assisted Treatment (MAT) for Opioid Use Disorder (OUD); home versus office ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7302321/

Effects of Medication-Assisted Treatment (MAT) for Opioid Use ... The studies reported on a large number of highly diverse functional outcome measures, including verbal memory, attention, insomnia, fatigue, and ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2760032

Comparative Effectiveness of Different Treatment Pathways ... Treatment with buprenorphine or methadone was associated with reductions in overdose and serious opioid-related acute care use compared with other treatments.

5. cdc.gov cdc.gov/mmwr/volumes/73/wr/mm7325a1.htm

Treatment for Opioid Use Disorder: Population Estimates In 2022, 3.7% of US adults aged ≥18 years needed OUD treatment. Among these, only 25.1% received medications for OUD.

6. cdc.gov cdc.gov/overdose-resources/search/pages/2019-133.html

Medication-Assisted Treatment for Opioid Use Disorder Medication-assisted treatment (MAT) (also known as medication- based treatment) has been shown to be effective for many people with opioid use disorder.

7. roots-recovery.com roots-recovery.com/mat-in-opioid-addiction-efficacy-safety-and-long-term-outcomes/

MAT in Opioid Addiction: Efficacy, Safety, and Long-Term ... MAT demonstrates higher retention rates compared to non-medicated approaches, indicating its effectiveness. Patients engaged in MAT tend to be ...

8. fda.gov fda.gov/drugs/information-drug-class/information-about-medications-opioid-use-disorder-moud

Information about Medications for Opioid Use Disorder ... All three of these treatments have been demonstrated to be safe and effective. FDA is working to identify treatment needs, expand access to ...

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

Medications for Opioid Use Disorder Medications for opioid use disorder reduce the risk of overdose deaths and of behaviors that increase the risk of infectious disease, including ...