Mobile Mindfulness Training for Opioid Use Disorder

Overseen By Natalya Means

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Amy Meadows

Must be taking: Buprenorphine, Naloxone

Must not be taking: Beta-blockers, Corticosteroids

Disqualifiers: Pregnancy, Psychotic illness, others

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

Compensation: Varies

Number of Visits: 4

Duration: 30 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether mobile mindfulness training can reduce stress in individuals undergoing treatment for opioid use disorder, particularly those with a history of childhood trauma. Participants will use a mindfulness app daily for a month and track their usage. The trial will compare stress levels before and after app use, with some participants starting their usual treatment first and others beginning with the app. It suits individuals with a stable opioid use disorder treatment plan and a history of childhood trauma. Participants will visit a clinic to assess stress levels through various tests. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance treatment options for those with similar experiences.

Will I have to stop taking my current medications?

If you are taking a beta-blocker, calcium-channel blocker, antiarrhythmic, corticosteroid, or immune modulator medication, you cannot participate in the trial. Otherwise, the protocol does not specify if you need to stop other medications.

What prior data suggests that mobile mindfulness training is safe for people with opioid use disorder?

Research has shown that mindfulness-based activities, such as Mobile Mindfulness Training, are generally safe. Participants in past studies reported no serious side effects. This training typically includes activities like meditation and self-awareness exercises, which do not involve physical procedures. Most people find these methods easy to handle and helpful for managing stress and cravings. Therefore, those considering Mobile Mindfulness Training are likely to find it safe and manageable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about mobile mindfulness training for opioid use disorder because it represents a non-pharmacological approach to treatment. Unlike standard options like medication-assisted therapy with methadone or buprenorphine, this method leverages mindfulness techniques delivered via a mobile platform. This offers a more accessible, flexible, and potentially stigma-free way to help individuals manage cravings and stress associated with opioid use disorder. By focusing on mental and emotional resilience, this approach could complement existing treatments and provide a holistic path to recovery.

What evidence suggests that mobile mindfulness training is effective for opioid use disorder?

Research has shown that mindfulness training can aid people with opioid use disorder. A study from Rutgers Health found that practicing mindfulness during treatment led to fewer dropouts and relapses. It also reduced cravings and withdrawal symptoms, common hurdles in recovery. Mindfulness can enhance overall quality of life, making it a promising option for managing stress and maintaining recovery. This trial will compare two approaches: one group will first receive mobile mindfulness training, followed by treatment as usual, while the other group will start with treatment as usual before transitioning to mobile mindfulness training. These findings suggest that mobile mindfulness training could be especially beneficial for people with opioid use disorder, particularly those who experienced childhood trauma. ^{1 2 4 5 6}

Who Is on the Research Team?

Amy Meadows, M.D.

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

This trial is for individuals in treatment for opioid use disorder who have experienced childhood trauma. They should be willing to use mobile mindfulness training daily and attend four clinic visits for stress level assessments.

Inclusion Criteria

Have a history of childhood trauma as measured by the Adverse Childhood Experiences scale and/or Childhood Trauma Questionnaire.

Currently enrolled in treatment for Opioid Use Disorder at a clinic affiliated with UKHealthCare or University of Kentucky

Clinically diagnosed with Opioid Use Disorder (per DSM5 criteria)

Exclusion Criteria

Current or expected pregnancy

Primary psychotic illness

Current mindfulness practice (i.e., participant reports practicing mindfulness for 10 minutes or more per week)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive mobile mindfulness training for 30 days and are encouraged to use it daily

30 days

4 visits (in-person)

Washout

A 14-day washout period between treatment phases

14 days

Crossover Treatment

Participants switch to the alternate treatment for 30 days

30 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

180 days

What Are the Treatments Tested in This Trial?

Interventions

• Mobile Mindfulness Training

Trial Overview

The study tests if a mobile app providing mindfulness training can reduce psychological stress in people with opioid addiction and past trauma. Participants will engage with the app daily over a month, tracking usage and undergoing stress evaluations.

How Is the Trial Designed?

Group I: Mobile Mindfulness First Experimental Treatment 1 Intervention

This is a crossover trial. Participants in this arm will have 30 days of mobile mindfulness training first then a 14 day washout and then 30 days of treatment as ususal.

Group II: Treatment As Usual First Active Control 1 Intervention

This is a crossover trial. Participants in this study arm will have 30 days of treatment as usual then a 14 day washout and then 30 days of mobile mindfulness training

Who Is Running the Clinical Trial?

Amy Meadows

Lead Sponsor

Trials

1

Recruited

60+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

A six-week mindfulness-based stress reduction (MBSR) intervention significantly decreased perceived stress, emotional regulation difficulties, and drug cravings in 15 underserved individuals undergoing treatment for opioid use disorder (OUD).

The results suggest that mindfulness interventions can be effective in improving mental health outcomes for vulnerable populations, highlighting the need for larger studies to further validate these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a Brief Mindfulness Intervention in Underserved Individuals Receiving Inpatient Treatment for Opioid Use Disorder: A Pilot Study. Kennelly, NR., Ray, S.[2023]

The pilot study involving 18 adults with Opioid Use Disorder showed that the Mindful Recovery OUD Care Continuum (M-ROCC) was feasible and acceptable, with 89% of participants retained in the program at 4 weeks and 72% at 24 weeks.

Participants demonstrated significant increases in mindfulness over the 24-week period, which correlated with their frequency of mindfulness practice, suggesting that integrating mindfulness-based interventions could enhance retention in buprenorphine/naloxone treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of mindful recovery opioid use care continuum (M-ROCC): A concurrent mixed methods study. Fatkin, T., Moore, SK., Okst, K., et al.[2023]

A randomized controlled trial will assess the effectiveness of mindfulness-based relapse prevention (MBRP) for opioid use disorders, involving 240 participants who have completed initial treatment, over an 8-week intervention period.

The study aims to evaluate not only the frequency of opioid use but also various secondary outcomes such as cravings, withdrawal symptoms, and quality of life, while exploring the mechanisms behind MBRP's effectiveness in reducing opioid use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol for a randomized controlled trial of mindfulness-based relapse prevention for opioid use disorders. Zinzow, H., Shi, L., Rennert, L., et al.[2021]

A brief mindfulness-based intervention, consisting of a single 10- to 12-minute session and daily practice, was found to be feasible and well-accepted by 40 patients undergoing outpatient treatment for opioid addiction, with high follow-up completion rates (90% at 6 months).

Patients who engaged in high levels of mindfulness practice (at least 5 minutes daily) experienced significantly lower rates of relapse or treatment failure (11%) compared to those with low practice uptake (42%), suggesting that even short mindfulness training can effectively support recovery from opioid addiction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Ultra-Brief Mindfulness-Based Intervention for Patients in Treatment for Opioid Addiction with Buprenorphine: A Primary Care Feasibility Pilot Study. Bloom-Foster, J., Mehl-Madrona, L.[2020]

The Mindful Recovery OUD Care Continuum (M-ROCC) program, a 24-week mindfulness-based intervention, significantly reduced comorbid pain and anxiety in patients undergoing buprenorphine treatment, as evidenced by improved scores on various psychological scales and decreased substance use.

Participants showed a notable decrease in positive urine toxicology results for cocaine and benzodiazepines, indicating that M-ROCC may help enhance retention in treatment and prevent substance misuse during opioid therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a trauma-informed mindful recovery program on comorbid pain, anxiety, and substance use during primary care buprenorphine treatment: A proof-of-concept study. Schuman-Olivier, Z., Fatkin, T., Creedon, TB., et al.[2023]

The pilot study successfully recruited and retained 10 participants within two weeks, demonstrating the feasibility of implementing the Mindful Awareness in Body-oriented Therapy (MABT) alongside buprenorphine treatment for opioid use disorder.

Participants in the MABT group showed significant improvements in interoceptive awareness skills compared to the control group, and feedback indicated high satisfaction with the intervention, suggesting it could be a beneficial adjunct therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of mindful body awareness training as an adjunct to office-based medication treatment of opioid use disorder. Price, CJ., Merrill, JO., McCarty, RL., et al.[2021]

Citations

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The study aims to evaluate not only the frequency of opioid use but also various secondary outcomes such as cravings, withdrawal symptoms, and quality of life, ...

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Our findings show that MORE-VR can be delivered as an adjunctive intervention to MOUD and suggest that MORE-VR may improve OUD treatment outcomes and modulate ...