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

60 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Mobile Mindfulness Training for Opioid Use Disorder?

Research shows that mindfulness-based interventions, like the ones used in the studies, can help reduce drug cravings, improve emotional regulation, and decrease stress in people with opioid use disorder. These benefits suggest that Mobile Mindfulness Training could be effective in supporting recovery from opioid addiction. ^{1 2 3 4 5}

Is Mobile Mindfulness Training safe for humans?

The studies on mindfulness-based interventions, including Mobile Mindfulness Training, suggest they are generally safe for humans. Participants in these studies reported positive experiences, and there were no significant safety concerns mentioned. ^{1 2 4 5 6}

How does Mobile Mindfulness Training differ from other treatments for opioid use disorder?

Mobile Mindfulness Training is unique because it uses mindfulness techniques, which focus on being present and aware, to help manage opioid use disorder. Unlike traditional medication treatments, this approach can be accessed through mobile devices, making it more accessible and convenient for users to practice mindfulness regularly. ^{1 2 3 4 5}

What is the purpose of this trial?

The goal of this clinical trial is to learn if mobile mindfulness training can help people in treatment for opioid use disorder. The main questions it aims to answer are: * Will people with opioid use disorder and childhood trauma use mobile mindfulness training? * Will mobile mindfulness training help people with opioid use disorder and childhood trauma have decreased markers of psychological stress? Participants will: Be given access to mobile mindfulness training and encouragement to use it daily for 30 days. Keep a diary of how often mobile mindfulness training is used. Visit the clinic four times to measure stress levels, including written rating scales, blood work, and heart rate tests.

Research Team

Amy Meadows, M.D.

Principal Investigator

University of Kentucky

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. United States 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. [2021]

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

Study protocol for a randomized controlled trial of mindfulness-based relapse prevention for opioid use disorders. [2021]

3. United States 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. [2020]

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

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

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

Feasibility and acceptability of mindful recovery opioid use care continuum (M-ROCC): A concurrent mixed methods study. [2023]

6. England 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. [2023]