ACT + Mindfulness for Chronic Pain & Opioid Use Disorder

(HOPE Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to managing chronic pain and preventing relapse in Opioid Use Disorder (OUD). It compares two treatments: one combines Acceptance and Commitment Therapy with Mindfulness-Based Relapse Prevention (ACT + MBRP), and the other provides enhanced usual care with educational resources. Participants will either join group therapy sessions or receive a brochure with information on managing pain and preventing opioid overdose. This trial suits individuals who have been on a stable dose of buprenorphine for at least a month and have experienced chronic pain for more than six months. As an unphased trial, it offers a unique opportunity to explore innovative treatments for chronic pain and OUD management.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that Acceptance and Commitment Therapy (ACT) combined with Mindfulness-Based Relapse Prevention (MBRP) is generally easy for people to handle. Studies on similar treatments for opioid misuse and pain have not found major safety issues. For example, one study found that participants managed the therapy sessions without serious problems. This suggests the treatment is safe for people with chronic pain and opioid use disorder. However, discussing these findings with a healthcare provider is important to understand their relevance to individual cases. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ACT + MBRP treatment because it combines Acceptance and Commitment Therapy with Mindfulness-Based Relapse Prevention, offering a fresh approach for those dealing with chronic pain and opioid use disorder. Unlike standard treatments such as medication-assisted therapy, ACT + MBRP focuses on enhancing patients' willingness to coexist with pain while still pursuing meaningful activities in their lives. This method also emphasizes present-focused awareness, helping individuals break the cycle of distress avoidance and fostering behavioral change through group discussions, role-play, and homework. This unique blend of psychological strategies aims to equip patients with practical skills and insights to manage their conditions more effectively.

What evidence suggests that this trial's treatments could be effective for chronic pain and opioid use disorder?

This trial will compare Acceptance and Commitment Therapy combined with Mindfulness-Based Relapse Prevention (ACT + MBRP) to Enhanced Usual Care (EUC) for individuals with chronic pain and opioid use disorder. Studies have shown that combining ACT with MBRP can reduce both pain and the risk of opioid relapse. Research indicates that this approach helps individuals manage chronic pain by teaching them to accept discomfort and focus on meaningful life activities. Initial findings suggest that mindfulness practices help individuals recognize and respond to triggers—situations that might cause cravings—in healthier ways. Overall, this dual approach aims to ease pain and support long-term recovery from opioid use disorder. ^{1 3 4 6 7}

Who Is on the Research Team?

Katie Witkiewitz, PhD

Principal Investigator

University of New Mexico

Are You a Good Fit for This Trial?

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 have been experiencing chronic pain for more than 6 months.

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

You are receiving medical care at one of the clinics involved in the study.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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 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]

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]

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]

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]

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/10622257

3RM1DA055301-01S1 - NIH RePORTER The HOPE Trial is a multisite effectiveness- implementation trial investigating the effectiveness of an integrated treatment for chronic pain and OUD ( ...

2. withpower.com withpower.com/trial/phase-opioid-related-disorders-9-2022-d64cd

ACT + Mindfulness for Chronic Pain & Opioid Use Disorder ... This study is a multisite randomized clinical trial of a treatment designed to reduce pain interference while simultaneously addressing relapse prevention ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04278352

Mindfulness-Based Relapse Prevention for Opioid and ... A randomized controlled trial will examine mindfulness-based relapse prevention (MBRP) program outcomes for 240 individuals who have completed treatment for ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1551714423000198

Rationale and design of a multisite randomized clinical trial ... Aim 1: The primary aim is to determine the efficacy of the 12 week ACT+MBRP group treatment in comparison to a 12-week education control (EC) group treatment ...

5. mindfulrp.com mindfulrp.com/research

Research Below are summaries of sample journal articles assessing the efficacy, effectiveness and mechanisms of mindfulness-based approaches to addictions treatment.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36693589/

The pain and opioids integrated treatment in veterans ... This study will determine the efficacy of an integrated behavioral treatment program for pain interference and hazardous opioid use among veterans with chronic ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7542006/

Integrated Behavioral Treatment for Veterans With Co ... The present study sought to test the feasibility and initial efficacy of an integrated treatment that combined ACT and MBRP to address opioid misuse, pain ...