ACT + Mindfulness for Chronic Pain & Opioid Use Disorder

(HOPE Trial)

Recruiting at 1 trial location

Overseen By Katie Witkiewitz, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of New Mexico

Must be taking: Buprenorphine

Disqualifiers: Schizophrenia, Delusional disorder, others

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

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

160 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is a multisite randomized clinical trial of a treatment designed to reduce pain interference while simultaneously addressing relapse prevention among individuals who have co-occurring chronic pain and Opioid Use Disorder (OUD). This study will recruit approximately 160 individuals who are currently being treated in clinics specializing in the physician management of OUD. To increase generalizability of study findings and increase internal validity of the physician management component of treatment, all participants will be stabilized on buprenorphine for OUD as part of their usual clinical care. Individuals will be randomized to either: (1) enhanced usual care or (2) the integrated ACT + MBRP treatment. The investigators hypothesize that: (1) the combination of ACT + MBRP in buprenorphine-prescribed patients with chronic pain will be more efficacious across primary and secondary outcome measures in comparison to Enhanced Usual Care and (2) examination of treatment mechanism data will indicate treatment-related changes that are consistent with the theoretical models of ACT+MBRP.

Will I have to stop taking my current medications?

The trial requires participants to be stabilized on buprenorphine for at least one month, so you will need to continue taking this medication. The protocol does not specify if you need to stop other medications.

What data supports the effectiveness of the treatment ACT + Mindfulness for Chronic Pain & Opioid Use Disorder?

Research suggests that combining Acceptance and Commitment Therapy (ACT) with Mindfulness-Based Relapse Prevention (MBRP) can be effective for people dealing with both chronic pain and opioid use disorder. Studies have shown that mindfulness-based approaches, like MBRP, can help reduce relapse rates and improve recovery outcomes in individuals with substance use disorders, including opioid addiction. ^{1 2 3 4 5}

Is ACT + Mindfulness safe for humans?

Mindfulness-based interventions, including those combined with Acceptance and Commitment Therapy (ACT), have been used safely in various studies for conditions like substance use disorders, depression, anxiety, and chronic pain. These treatments focus on improving emotional regulation and reducing negative behaviors, and no significant safety concerns have been reported in the research provided. ^{2 3 5 6 7}

How is the ACT + Mindfulness treatment for chronic pain and opioid use disorder different from other treatments?

The ACT + Mindfulness treatment is unique because it combines Acceptance and Commitment Therapy (ACT) and Mindfulness-Based Relapse Prevention (MBRP) to simultaneously address both chronic pain and opioid misuse, which few treatments do. This integrated approach targets pain interference and opioid misuse, offering a novel way to manage these co-occurring conditions. ^{2 7 8 9 10}

Research Team

Katie Witkiewitz, PhD

Principal Investigator

University of New Mexico

Eligibility Criteria

The HOPE Trial is for adults over 18 with chronic pain and Opioid Use Disorder, who are patients at participating clinics. They must be willing to follow the study's procedures, have had chronic pain for more than six months, and been on a stable dose of buprenorphine for at least one month.

Inclusion Criteria

I am 18 years old or older.

I have been experiencing chronic pain for more than 6 months.

I am willing and able to follow all study rules and attend all appointments.

Exclusion Criteria

Unable to read English.

You have been diagnosed with schizophrenia, delusional disorder, or other serious mental health conditions.

You have a serious problem with drugs or alcohol that needs more than just outpatient treatment, like needing to stay in a hospital for detoxification.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either enhanced usual care or the integrated ACT + MBRP treatment over 12 weeks

12 weeks

12 weekly virtual group-based sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Monthly assessments

Treatment Details

Interventions

• Acceptance and Commitment Therapy + Mindfulness Based Relapse Prevention (ACT + MBRP)
• Enhance Usual Care (EUC)

Trial Overview This trial tests whether Acceptance and Commitment Therapy combined with Mindfulness Based Relapse Prevention (ACT + MBRP) is more effective than Enhanced Usual Care in reducing pain interference and preventing relapse in individuals stabilized on buprenorphine.

Participant Groups

Group I: ACT + MBRP Intervention Experimental Treatment 1 Intervention

The ACT + MBRP group will follow a manualized clinical protocol. Treatment will include 12 weekly, virtual group-based sessions, each lasting 90 minutes. Group sizes will range from three to ten participants. All sessions will be audio recorded for fidelity. Over the course of the group meetings, participants identify areas of meaningful functioning that have been adversely impacted by pain, learn methods to enhance pain willingness in the service of these meaningful areas, and practice present-focused awareness skills. Group sessions include discussions of the impact of pain and distress avoidance, identifying alternatives to this avoidance and establishing plans for behavior change, demonstration and role-playing exercises, and homework assignments. Participants are provided with a treatment manual to help guide and inform practice outside of group sessions.

Group II: Enhanced Usual Care (EUC) Active Control 1 Intervention

The Enhanced Usual Care (EUC) condition will supplement standard practices within the study sites related to chronic pain and OUD education. Participants randomized to the EUC condition will receive a brochure (in-person, via email, or via text message) with a list of chronic pain treatment resources, signs and management of opioid overdose including naloxone, and overdose prevention, and will encouraged to schedule an appointment with a clinical provider if they would like to discuss any current or past symptoms. In addition to receiving the brochure, EUC condition participants will meet with a therapist remotely for approximately 15 minutes for a descriptive overview of the brochure. In this session, the therapist will point out the resources in the brochure and read the helpful tips out loud to the participant. This session will be audio recorded for fidelity.

Who Is Running the Clinical Trial?

University of New Mexico

Lead Sponsor

Trials

393

Recruited

3,526,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Wake Forest University

Collaborator

Trials

193

Recruited

151,000+

University of Michigan

Collaborator

Trials

1,891

Recruited

6,458,000+

Findings from Research

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 multisite randomized controlled trial involving 160 veterans with chronic pain and opioid use disorder will evaluate the efficacy of an integrated treatment combining Acceptance and Commitment Therapy and Mindfulness-Based Relapse Prevention, focusing on pain interference and hazardous opioid use.

The study aims to address a significant gap in treatment options by assessing outcomes over 12 months, including pain interference and opioid misuse, which could lead to improved care for veterans on buprenorphine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale and design of a multisite randomized clinical trial examining an integrated behavioral treatment for veterans with co-occurring chronic pain and opioid use disorder: The pain and opioids integrated treatment in veterans (POSITIVE) trial. Vowles, KE., Witkiewitz, K., Clarke, E., 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]

Mindfulness-based relapse prevention (MBRP) was effective in reducing craving, anxiety, and depression among individuals receiving medication for opioid use disorder (MOUD), with significant improvements observed over 36 weeks.

Participants in the MBRP group showed similar retention and relapse rates compared to those receiving treatment as usual (TAU), suggesting that MBRP can be a beneficial outpatient therapy alongside MOUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Testing Mindfulness-Based Relapse Prevention with Medications for Opioid Use Disorder Among Adults in Outpatient Therapy: a Quasi-experimental Study. Zullig, KJ., Lander, LR., Tuscano, M., et al.[2022]

An eight-week mindfulness-based relapse prevention (MBRP) program was tested on 20 cannabis users, but preliminary results showed no significant difference in the number of joints smoked compared to those receiving standard treatment.

Despite the lack of significant quantitative results, many participants in the MBRP group reported positive qualitative changes in their cannabis consumption, suggesting that mindfulness may still play a beneficial role in managing substance use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based relapse prevention for cannabis regular users: Preliminary outcomes of a randomized clinical trial. Schneegans, A., Bourgognon, F., Albuisson, E., et al.[2022]

The study is a two-site, randomized controlled trial comparing Mindfulness-Based Relapse Prevention (MBRP) to 12-Step Facilitation (TSF) in military Veterans who have completed intensive outpatient treatment for substance use disorders, with an 8-week intervention followed by long-term follow-ups.

The primary goal is to determine if MBRP is more effective than TSF in preventing relapse and improving recovery outcomes, including quality of life and mental health, in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of mindfulness-based relapse prevention in veterans with substance use disorders: Design and methodology of a randomized clinical trial. Brady, KT., Killeen, T., Baker, NL.[2021]

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]

Mindfulness-based cognitive therapy (MBCT) showed potential benefits for patients with chronic pain and opioid use disorder (OUD), including reduced opioid cravings and improved pain coping strategies, but only four out of 21 invited patients participated in the program.

Barriers to participation included the timing of the intervention and practical difficulties, while positive attitudes towards MBCT and intrinsic motivation were key facilitators; adjusting the timing and offering MBCT online could improve feasibility for more patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based cognitive therapy for chronic noncancer pain and prescription opioid use disorder: A qualitative pilot study of its feasibility and the perceived process of change. Ellerbroek, H., Hanssen, I., Lathouwers, K., et al.[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 study assessed the feasibility and initial efficacy of an integrated psychosocial treatment combining Acceptance and Commitment Therapy and Mindfulness Based Relapse Prevention for Veterans with chronic pain and hazardous opioid use, involving 37 participants over a 6-month follow-up period.

Results indicated that the integrated treatment significantly reduced opioid misuse, pain interference, and pain behavior compared to usual care, demonstrating its potential as a viable option for addressing both chronic pain and opioid-related issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated Behavioral Treatment for Veterans With Co-Morbid Chronic Pain and Hazardous Opioid Use: A Randomized Controlled Pilot Trial. Vowles, KE., Witkiewitz, K., Cusack, KJ., et al.[2021]

References

1. 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]

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

Rationale and design of a multisite randomized clinical trial examining an integrated behavioral treatment for veterans with co-occurring chronic pain and opioid use disorder: The pain and opioids integrated treatment in veterans (POSITIVE) trial. [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

Testing Mindfulness-Based Relapse Prevention with Medications for Opioid Use Disorder Among Adults in Outpatient Therapy: a Quasi-experimental Study. [2022]

5. France pubmed.ncbi.nlm.nih.gov

Mindfulness-based relapse prevention for cannabis regular users: Preliminary outcomes of a randomized clinical trial. [2022]

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

Efficacy of mindfulness-based relapse prevention in veterans with substance use disorders: Design and methodology of a randomized clinical trial. [2021]

7. 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]

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

Mindfulness-based cognitive therapy for chronic noncancer pain and prescription opioid use disorder: A qualitative pilot study of its feasibility and the perceived process of change. [2023]

9. 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]

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

Integrated Behavioral Treatment for Veterans With Co-Morbid Chronic Pain and Hazardous Opioid Use: A Randomized Controlled Pilot Trial. [2021]