What side effects are associated with this type of intervention?

The most common treatments for Opioid Use Disorder (OUD) include medications such as methadone, buprenorphine, and naltrexone, as well as behavioral interventions like cognitive-behavioral therapy (CBT) and mindfulness-based relapse prevention (MBRP). Methadone and buprenorphine can cause side effects such as constipation, sweating, drowsiness, and potential for dependency. Naltrexone may lead to nausea, headache, dizziness, and liver enzyme abnormalities. Behavioral interventions like CBT and MBRP generally have fewer physical side effects but can initially increase anxiety or emotional discomfort as patients confront their substance use issues. Overall, these treatments aim to reduce relapse, cravings, and psychological stress, improving adherence to MOUD and overall quality of life.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Opioid Use Disorder (OUD), including methadone, buprenorphine, and naltrexone. Methadone is a long-acting opioid agonist, buprenorphine is a partial opioid agonist, and naltrexone is an opioid antagonist. These medications are often used in combination with behavioral interventions to improve adherence, reduce relapse and cravings, and address psychological stress. Programs like the Minds and Mentors Program, which incorporate behavioral therapies to support medication adherence and reduce stress, align well with these FDA-approved treatments by providing comprehensive care that addresses both the physiological and psychological aspects of OUD.

What other types of research exist?

Promising novel alternatives to the Minds and Mentors Program for OUD patients include: 1) Distress Tolerance (DT) treatment, which incorporates exposure-based and acceptance-based approaches and has shown feasibility and acceptability in pilot studies. 2) Mindfulness-Based Relapse Prevention (MBRP), which has been effective in improving quality of life and reducing cravings in methadone-treated patients. 3) Cognitive-Behavioral Therapy (CBT) tailored for relapse prevention, which has demonstrated effectiveness in reducing relapse rates among opioid-dependent patients in methadone maintenance treatment.

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Minds and Mentors Program for Opioid Use Disorder (MiMP Trial)

N/A

Recruiting

Research Sponsored by University of Alabama, Tuscaloosa

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 19 and older

Currently receiving MOUD (e.g. methadone, naloxone, naltrexone, and buprenorphine) from an established provider

Must not have

Significant cognitive impairment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 9 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests the Minds and Mentors Program, a group therapy that uses mindfulness and peer support, in people with opioid use disorder who are on medication. The goal is to see if it helps them stick to their medication, reduces relapse rates, and lowers stress and cravings. Mindfulness-based relapse prevention (MBRP) includes the teaching and practice of mindfulness meditation to help patients change their relationship to drug cravings and other negative emotional states.

Who is the study for?

This trial is for adults over 19 with opioid use disorder who are currently on medication-assisted treatment (like methadone or buprenorphine). They must be stable on their medication, able to attend 12 therapy sessions and follow-ups for 9 months, have internet access, and not be in immediate need of intensive care like detox. Pregnant women, those with unstable medical conditions or active psychosis, suicidal thoughts, or significant cognitive impairment cannot join.

What is being tested?

The study tests the Minds and Mentors Program against a Twelve Step Facilitation program for people using medications to treat opioid addiction. Participants will randomly receive one of these treatments in groups of five. The goal is to see if the program helps stick to treatment better, reduces relapse and cravings, lowers anxiety/stress/depression levels, and affects cortisol related to drug cues.

What are the potential side effects?

Since this trial involves group therapy programs rather than medications beyond participants' current treatments for opioid use disorder (MOUD), there aren't new side effects from drugs being tested here. However, discussing sensitive topics during therapy could potentially cause emotional discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 19 years old or older.

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I am currently on medication for opioid use disorder.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have significant difficulty with my memory or thinking.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 9 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~9 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adherence Rate

Secondary study objectives

Anxiety

Cravings

Depression

+3 more

Other study objectives

Cortisol Reactivity

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Mindfulness based relapse prevention and peer mentoringExperimental Treatment1 Intervention

Treatment will utilize a group format. The twelve-week mindfulness based relapsed prevention group therapy intervention is co-led by a licensed counselor and a peer mentor for eight weeks, followed by group sessions led by peer mentors for an additional four weeks.

Group II: 12 Step Treatment ProgramActive Control1 Intervention

Participants in the attentional control group will attend 12 weeks of a enhanced 12 step treatment program.

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Opioid Use Disorder (OUD) include Medication for Opioid Use Disorder (MOUD) and behavioral interventions. MOUD, such as methadone, buprenorphine, and naltrexone, works by binding to opioid receptors in the brain to reduce cravings and withdrawal symptoms, stabilizing brain chemistry. Behavioral interventions like cognitive-behavioral therapy (CBT) and contingency management aim to change the patient's behavior and thought patterns related to drug use. These treatments help improve adherence to MOUD, reduce relapse rates, and decrease psychological stress and cortisol levels. Combining these approaches addresses both the physiological and psychological aspects of OUD, enhancing the effectiveness of long-term recovery efforts.

Efficacy and mechanisms of a single-session behavioral medicine class among patients with chronic pain taking prescription opioids: study protocol for a randomized controlled trial.