Mindfulness App for Opioid Dependence and Chronic Pain

Overseen By Corey Roos, Ph.D

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Arizona State University

Must be taking: Medication-assisted treatment

Disqualifiers: Chronic malignant pain, Psychotic disorder, others

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

Compensation: Varies

Number of Visits: 2

10 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to evaluate whether a smartphone app-based ecological momentary intervention called Mindful Journey, which teaches mindfulness skills, can support adults in recovery from both opioid use disorder and chronic pain. The primary objective of this pilot study is to assess the feasibility and acceptability of Mindful Journey in this population.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, you must be enrolled in medication-assisted treatment for opioid use disorder to participate.

What data supports the effectiveness of the treatment Mindful Journey for opioid dependence and chronic pain?

Research shows that mindfulness-based treatments like Mindfulness-Oriented Recovery Enhancement (MORE) can reduce opioid cravings, pain, and negative emotions in people with chronic pain on long-term opioid therapy. Additionally, mindfulness interventions have been found to decrease drug cravings and improve emotional regulation and stress in individuals with opioid use disorder. ^{1 2 3 4 5}

Is the Mindfulness App for Opioid Dependence and Chronic Pain safe for humans?

Research on mindfulness-based interventions, like Mindful Recovery and Mindfulness-Oriented Recovery Enhancement, shows they are generally safe for humans. These programs have been used in studies with people dealing with opioid use disorder and chronic pain, and no major safety concerns have been reported. ^{1 2 4 6 7}

How does the Mindful Journey treatment differ from other treatments for opioid dependence and chronic pain?

Mindful Journey is unique because it uses mindfulness, a mind-body approach that focuses on awareness of the present moment, to help reduce opioid cravings, pain, and stress. Unlike traditional medication-based treatments, it involves practicing mindfulness exercises regularly, which can improve emotional regulation and decrease the likelihood of relapse. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for adults over 18 who speak English, are in medication-assisted treatment for opioid use disorder, have chronic pain but not from cancer or inflammatory diseases like rheumatoid arthritis, and own a smartphone. Those with psychotic disorders or previous participation in the app's development phase cannot join.

Inclusion Criteria

Fluent in English

Enrollment in medication-assisted treatment for opioid use disorder

Has a smartphone.

Exclusion Criteria

Self-reporting of psychotic disorder symptoms

Participated in the previous phase of the study in which participants provided feedback to inform the development of the Mindful Journey app.

I have long-term pain from cancer or a disease causing body-wide inflammation.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training

Participants complete a training session to learn about the study procedure and the mobile app platform

1 week

1 visit (in-person or virtual)

Intervention

Participants use the Mindful Journey app for 8 weeks, completing 14 foundational modules and daily check-in surveys. Weekly phone check-ins are conducted to support engagement.

8 weeks

Weekly phone check-ins

Follow-up

Participants complete a series of self-report batteries and participate in a brief exit interview to gather feedback and suggestions for improving the app

1 week

1 visit (in-person or virtual)

Treatment Details

Interventions

• Mindful Journey

Trial Overview The study tests 'Mindful Journey,' a mindfulness-based smartphone app designed to help individuals managing both opioid addiction and chronic pain. The focus is on seeing if people will find it easy to use and helpful.

Participant Groups

Group I: Evaluating the Feasibility and Acceptability of Mindful Journey Prototype Experimental Treatment 1 Intervention

In this single arm trial, participants will complete surveys and interviews about experiences with opioid and other substance use, chronic pain, and treatments, and a brief timeline follow-back assessment for substance use. Participants will also be completing a training session to learn about the study procedure, and the mobile app platform. Participants will enter the intervention period (8-weeks) and complete 14 foundational modules throughout the intervention period using the Mindful Journey app. Daily brief check-in surveys will be completed via the app. Based on these survey responses, participants will receive brief, tailored momentary mindfulness coaching. Study staff will also conduct weekly 5-10 minute phone check-ins to support engagement. The final visit will occur following the intervention period and the participant will complete a series of self-report batteries and participate in a brief exit interview to gather feedback and suggestions for improving the app.

Who Is Running the Clinical Trial?

Arizona State University

Lead Sponsor

Trials

311

Recruited

109,000+

Yale University

Collaborator

Trials

1,963

Recruited

3,046,000+

Findings from Research

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]

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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Mindfulness-Oriented Recovery Enhancement reduces opioid craving, pain, and negative affect among chronic pain patients on long-term opioid therapy: An analysis of within- and between-person state effects. [2022]

2. 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]

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

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

4. 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]

5. 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]

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]

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

Mindfulness-oriented recovery enhancement reduces opioid dose in primary care by strengthening autonomic regulation during meditation. [2021]