Mindfulness Therapy + Methadone for Opioid Use Disorder
(IMPOWR-MORE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how mindfulness therapy, combined with methadone treatment, can assist individuals with opioid use disorder. It seeks to determine if adding mindfulness practices can reduce drug use, cravings, and symptoms such as depression and anxiety. Participants will receive either intensive mindfulness sessions (Mindfulness Oriented Recovery Enhancement, MORE), a simpler mindfulness approach (Scripted Mindfulness Practice, SMP), or just methadone treatment. This trial suits English-speaking individuals already on methadone who have experienced ongoing pain for at least three months. As a Phase 3 trial, it represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking treatment advancements.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does require that you continue methadone treatment.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that Mindfulness-Oriented Recovery Enhancement (MORE) aids individuals with opioid misuse and chronic pain. Two studies found MORE to be both effective and safe, with no major side effects reported, indicating participants generally tolerate it well.
Scripted Mindfulness Practice (SMP) offers a simpler form of mindfulness training. Although specific safety data for SMP is limited, similar mindfulness practices typically pose minimal risks. Mindfulness exercises are generally safe for most people.
Treatments in a Phase 3 trial have already demonstrated sufficient safety for testing in larger groups. Therefore, MORE and SMP are expected to be well-tolerated by participants.12345Why are researchers excited about this trial's treatments?
Researchers are excited about combining mindfulness therapy with methadone for opioid use disorder because it offers a holistic approach to treatment. Most treatments, like methadone, focus primarily on the physical aspects of addiction. However, Mindfulness-Oriented Recovery Enhancement (MORE) and Scripted Mindfulness Practice (SMP) aim to address the psychological and emotional components by teaching patients to manage cravings and stress through mindfulness. This dual approach has the potential to improve overall treatment outcomes by fostering mental resilience alongside traditional medication.
What evidence suggests that this trial's treatments could be effective for opioid use disorder?
Research shows that Mindfulness-Oriented Recovery Enhancement (MORE), which participants in this trial may receive, can help people with opioid use disorder. Studies have found that MORE reduces opioid cravings and helps manage long-term pain. It also improves mood and overall quality of life. Another treatment arm in this trial involves the scripted mindfulness practice (SMP), a simpler version that includes basic mindfulness exercises. Although less specific research exists on SMP alone, mindfulness practices in general have been shown to help control opioid use. Both approaches aim to assist people in methadone treatment with managing cravings and improving their well-being.23678
Who Is on the Research Team?
Eric Garland, Ph
Principal Investigator
Rutgers Robert Wood Johnson Medical School
Are You a Good Fit for This Trial?
This trial is for English-speaking adults over 18 who are on methadone treatment and have been experiencing pain for at least three months. It's not suitable for those unable to attend sessions, with severe cognitive issues or psychosis, at risk of suicide, or with previous formal mindfulness training.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either Mindfulness-Oriented Recovery Enhancement, Scripted Mindfulness Practice, or Treatment-as-Usual alongside methadone treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment, including drug use, craving, and chronic pain
What Are the Treatments Tested in This Trial?
Interventions
- Mindfulness Oriented Recovery Enhancement (MORE)
- Scripted Mindfulness Practice (SMP)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Rutgers, The State University of New Jersey
Lead Sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
University of Utah
Collaborator