ACT + MBRP for Chronic Pain and Opioid Abuse

(POSITIVE Trial)

Not currently recruiting at 3 trial locations

Overseen By Kevin E Vowles, 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: 15

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist veterans managing chronic pain while using buprenorphine for opioid use disorder. It seeks to determine if combining Acceptance and Commitment Therapy with Mindfulness-Based Relapse Prevention (ACT + MBRP) more effectively reduces pain and cravings than education on opioids and pain management alone. Participants will join either the therapy group or the education group, both conducted through telehealth. Veterans who have maintained a stable dose of buprenorphine for at least a month and have experienced chronic pain for more than six months may qualify. As an unphased trial, this study offers veterans the chance to explore innovative therapies that could improve their quality of life.

Do I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must be stabilized on a consistent dose of buprenorphine for at least 30 days before joining the study.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must be stabilized on a consistent dose of buprenorphine for at least 30 days before joining.

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

Research has shown that Acceptance and Commitment Therapy (ACT) and Mindfulness-Based Relapse Prevention (MBRP) are both safe and effective for individuals with chronic pain and opioid use disorder. In past studies, ACT helped people manage their pain better in daily life by reducing the disruption of activities. MBRP has also been well-tolerated and effective in reducing cravings and preventing relapse in those with substance use disorders. These therapies focus on behavior rather than medication, often resulting in fewer side effects. Overall, evidence strongly supports the safety of combining ACT with MBRP, making it a promising treatment to explore. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about ACT + MBRP for chronic pain and opioid abuse because it combines Acceptance and Commitment Therapy with Mindfulness-Based Relapse Prevention, offering a fresh approach to managing pain and reducing opioid use. Unlike standard treatments that often focus solely on medication management, this method emphasizes psychological flexibility and mindfulness to help patients handle pain and cravings more effectively. Delivered via telehealth, it provides accessible, group-based support that can fit into patients' lives more easily than traditional in-person therapy sessions. This innovative approach has the potential to empower patients with skills for long-term management of their conditions.

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

In this trial, participants will join one of two groups. The first group will receive Acceptance and Commitment Therapy (ACT) combined with Mindfulness-Based Relapse Prevention (MBRP). Research has shown that ACT and MBRP can reduce pain's impact on daily life and improve overall well-being. Studies indicate that ACT effectively decreases pain's impact and increases psychological flexibility, enabling adaptation to different situations. Mindfulness-based approaches like MBRP have slightly reduced the number of days people use substances. ACT has also led to higher rates of remaining substance-free compared to other treatments for substance use disorders. For veterans with chronic pain and opioid use disorder, combining ACT with MBRP may significantly aid in managing pain and reducing dependency.

The second group, the Education Control (EC) group, will receive opioid and pain education sessions as part of the interdisciplinary pain program. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for veterans aged 21-75 with chronic pain who are taking buprenorphine for opioid use disorder (OUD) and have been on a stable dose for 1-6 months. Participants must be enrolled in VA Co-Occurring Disorders clinics, willing to follow the study plan, and available throughout the study. Those with severe mental health conditions or substance use disorders needing intense treatment cannot join.

Inclusion Criteria

I have been on a stable dose of buprenorphine for 1 to 6 months.

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

I need more than outpatient care for my severe substance use disorder.

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

Unable to read English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a three-month integrated behavioral treatment combining Acceptance and Commitment Therapy and Mindfulness-Based Relapse Prevention, or an education control

12 weeks

12 weekly group-based sessions via telehealth

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Follow-up assessments at 3, 6, and 12 months post-treatment

What Are the Treatments Tested in This Trial?

Interventions

• ACT+MBRP
• Education control

Trial Overview The trial tests an integrated therapy combining Acceptance and Commitment Therapy with Mindfulness-Based Relapse Prevention (ACT+MBRP) against an education control program about chronic pain and opioids. The goal is to see if ACT+MBRP better reduces pain interference and prevents substance misuse compared to just getting educational sessions.

How Is the Trial Designed?

Group I: ACT + MBRP Experimental Treatment 1 Intervention

Acceptance and Commitment Therapy + Mindfulness Based Relapse Prevention (ACT + MBRP) group will follow a manualized clinical protocol. Treatment will include 12 weekly group-based sessions, each lasting 90 minutes. Group sizes will range from 3 to 8. ACT + MBRP will be delivered via the VA Video Connect telehealth platform.

Group II: Education Control (EC) Active Control 1 Intervention

The EC group will follow a protocol that combines opioid education sessions and psychology-led pain education sessions that are offered as part of the interdisciplinary pain program. Specifically, education will include 12 group-based sessions, each lasting 60 to 90 minutes. Group sizes will range from 3 to 8. EC will be delivered via the VA Video Connect telehealth platform.

Who Is Running the Clinical Trial?

University of New Mexico

Lead Sponsor

Trials

393

Recruited

3,526,000+

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

University of California, San Francisco

Collaborator

Trials

2,636

Recruited

19,080,000+

Seattle Institute for Biomedical and Clinical Research

Collaborator

Trials

55

Recruited

13,700+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

University of Utah

Collaborator

Trials

1,169

Recruited

1,623,000+

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

Vanderbilt University

Collaborator

Trials

714

Recruited

6,143,000+

Biomedical Research Institute of New Mexico

Collaborator

Trials

11

Recruited

2,300+

Queen's University, Belfast

Collaborator

Trials

179

Recruited

142,000+

Published Research Related to This Trial

Buprenorphine, classified as a partial µ-opioid receptor agonist, should not be viewed as having partial analgesic efficacy, meaning it can still provide effective pain relief comparable to full agonists.

The expert panel recommends considering buprenorphine before other opioids for chronic pain management due to its favorable safety profile and pharmacologic properties, and suggests that patients can switch to buprenorphine without a weaning period based on their previous opioid dosage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding Buprenorphine for Use in Chronic Pain: Expert Opinion. Webster, L., Gudin, J., Raffa, RB., et al.[2021]

Long-term opioid therapy (LTOT) has been found to have limited efficacy for chronic pain, leading to increased tapering of opioids, which can cause complications like worsening pain and declining function.

The concept of complex persistent opioid dependence (CPOD) is emerging as a useful framework to understand the challenges associated with both ineffective LTOT and the complications of opioid tapering, highlighting the need for further research and policy development regarding its treatment, including the use of buprenorphine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complex Persistent Opioid Dependence with Long-term Opioids: a Gray Area That Needs Definition, Better Understanding, Treatment Guidance, and Policy Changes. Manhapra, A., Sullivan, MD., Ballantyne, JC., 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]

This case report highlights that effective pain management is achievable for patients with opioid use disorder (OUD) on extended-release buprenorphine (ER-buprenorphine) through individualized, multidisciplinary approaches, as demonstrated in three different clinical scenarios.

Strategies for managing acute pain in these patients can include supplemental sublingual buprenorphine, non-opioid medications, and short-term use of full opioid agonists, while addressing barriers such as provider bias and access to specialized care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain Management in Patients With Opioid Use Disorder on Extended-release Buprenorphine: A Case Report. South, AM., Oller, D., Lofwall, M., et al.[2023]

The German Association for the Study of Pain initiated efforts in 1991 to simplify the prescription of strong opioids for severe pain, leading to a draft bill by the Ministry of Health that incorporates key recommendations.

The proposed changes include increased quantities of narcotic analgesics allowed per prescription and simplified prescription processes, which are expected to improve access to pain management for patients once approved in autumn 1992.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Revision of the legal prescription requirements for strong opioids in the federal republic of Germany-an initiative of the German association for the study of pain.]. Sorge, J.[2008]

A new set of measurement-based care (MBC) tools, including the TAPS tool for universal screening and the OUD Symptom Checklist for symptom tracking, has been developed to support primary care physicians in treating opioid use disorder (OUD) with buprenorphine.

These tools aim to enhance treatment capacity for OUD by providing structured guidance during the first 12 weeks of buprenorphine treatment, although further testing is needed to evaluate their feasibility and acceptability in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Creation of an algorithm for clinical decision support for treatment of opioid use disorder with buprenorphine in primary care. Dela Cruz, AM., Walker, R., Pipes, R., et al.[2021]

In a study of 6,849 patients with acute musculoskeletal injuries in North Carolina, 69.3% of opioid prescriptions adhered to the STOP Act's duration limits, indicating a significant level of compliance with the legislation.

Surgical patients were more likely to receive compliant prescriptions compared to non-surgical patients, while primary care sports medicine clinicians showed lower adherence rates than orthopedic surgeons, suggesting a need for targeted interventions to improve compliance among specific prescriber groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to legislation limiting opioid prescription duration following musculoskeletal injury. Wally, MK., Thompson, ME., Odum, S., et al.[2023]

A survey of 1618 healthcare professionals in Washington State revealed that only 41% treated patients with chronic noncancer pain (CNP) and nearly all of them managed patients on prescription opioids, indicating a significant reliance on opioid therapy.

Despite high engagement in patient history evaluation and ongoing interviews, 60% of providers felt only somewhat competent in prescribing opioids, and only 8.5% were very satisfied with their work with CNP patients, highlighting a need for improved education and support in opioid prescribing practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Statewide Survey of Healthcare Professionals: Management of Patients With Chronic Noncancer Pain. Howell, D., Kaplan, L.[2015]

Buprenorphine and buprenorphine/naloxone have been approved for office-based treatment of opioid dependence, and a consensus among experts emphasizes the need for comprehensive training and support for healthcare providers to effectively use these medications.

Key recommendations include the importance of concurrent counseling, proper patient induction protocols, and the necessity of follow-up treatment to prevent relapse, highlighting the multifaceted approach required for successful opioid dependence management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consensus statement on office-based treatment of opioid dependence using buprenorphine. Fiellin, DA., Kleber, H., Trumble-Hejduk, JG., et al.[2013]

In a study of 78 patients over six years at the High-Risk Pain Clinic, buprenorphine/naloxone was found to significantly reduce pain scores, indicating its efficacy in managing chronic pain for patients with a history of substance use disorder.

The clinic had a retention rate of 41%, suggesting that while many patients continued treatment, there is still a notable number who may not stay engaged in this multimodal approach to pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sublingual Buprenorphine/Naloxone and Multi-Modal Management for High-Risk Chronic Pain Patients. Kaski, S., Marshalek, P., Herschler, J., et al.[2021]

The EMPOWER study is a comprehensive, multi-state, randomized controlled trial designed to help patients with chronic pain safely reduce long-term opioid use through three different approaches: cognitive behavioral therapy, self-management, and usual care.

By collecting detailed patient-reported data and using real-time feedback, the study aims to provide valuable insights into the effectiveness of these methods for opioid tapering, ultimately improving patient outcomes and satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Effectiveness of Cognitive Behavioral Therapy for Chronic Pain and Chronic Pain Self-Management within the Context of Voluntary Patient-Centered Prescription Opioid Tapering: The EMPOWER Study Protocol. Darnall, BD., Mackey, SC., Lorig, K., et al.[2021]

The FDA mandated a series of 10 observational studies to accurately estimate the rates of opioid misuse, abuse, addiction, overdose, and death among patients on long-term opioid therapy, highlighting the need for better data on these serious risks.

While the studies have been feasible to conduct, challenges were encountered, such as the unsuccessful development of a validated algorithm for measuring abuse and addiction in existing databases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postmarketing studies program to assess the risks and benefits of long-term use of extended-release/long-acting opioids among chronic pain patients. Coplan, PM., Cepeda, MS., Petronis, KR., et al.[2020]

Opioids are increasingly used for long-term treatment of chronic nonmalignant pain, but their long-term benefits for pain relief and quality of life are still unproven.

Emerging studies highlight serious long-term risks associated with opioid use, including addiction, increased sensitivity to pain (opioid-induced hyperalgesia), cognitive disorders, and suppression of immune and reproductive functions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An update on the role of opioids in the management of chronic pain of nonmalignant origin. Højsted, J., Sjøgren, P.[2007]

Prescription monitoring programs (PMPs) have been implemented in 17 states to help prevent the diversion and abuse of controlled substances while ensuring they remain available for legitimate medical use.

A collaborative project by the Pain & Policy Studies Group aims to improve understanding of PMPs among healthcare providers and to balance the need for preventing drug abuse with the necessity of effective pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain management and prescription monitoring. Joranson, DE., Carrow, GM., Ryan, KM., et al.[2019]

Interdisciplinary pain rehabilitation programs (IPRPs) significantly improve both self-reported and performance-based functional outcomes in patients with chronic pain, regardless of whether they are using opioids or not, as shown in a study involving two cohorts over a 3-week treatment period.

The study found that improvements in function were evident immediately after treatment and persisted for at least 6 months, highlighting the effectiveness of IPRPs in helping patients discontinue opioid use while enhancing their physical and emotional well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longitudinal Treatment Outcomes for an Interdisciplinary Pain Rehabilitation Program: Comparisons of Subjective and Objective Outcomes on the Basis of Opioid Use Status. Gilliam, WP., Craner, JR., Cunningham, JL., et al.[2022]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S1526590021002078

Review Articles Efficacy of Online-Based Acceptance and ... Online ACT was more efficacious than controls regarding pain interference, pain intensity, depression, anxiety, mindfulness, and psychological flexibility.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8527365/

Mindfulness‐based interventions for substance use disorders When MBIs were compared with other treatments, our review and analysis showed that MBIs may slightly reduce days with substance use at post‐treatment and follow ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S221214472400053X

Effectiveness of acceptance and commitment therapy for ... ACT demonstrated higher abstinence rates than CBT conditions at EOT (p = 0.002). A lower age increased abstinence rates in the short (p = 0.004) ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6174685/

Current status of acceptance and commitment therapy for ... Overall, these reviews indicate that ACT can effectively lead to improved health outcomes. In 2014, Hann and McCracken systematically reviewed assessment ...

5. jpain.org jpain.org/article/S1526-5900(19)30866-1/pdf

Integrated Behavioral Treatment for Veterans With Co- ... In those with chronic pain, ACT is effective at reducing pain interference1,33,45,54 and MBRP has established effectiveness in substance use disorder.

6. sciencedirect.com sciencedirect.com/science/article/pii/S1526590019308661

Integrated Behavioral Treatment for Veterans With Co ... In those with chronic pain, ACT is effective at reducing pain interference,,, and MBRP has established effectiveness in substance use disorder populations.,, ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04278352

Mindfulness-Based Relapse Prevention for Opioid and ... Primary outcomes will include frequency of opioid/alcohol use, craving, withdrawal, and quality of life. Secondary outcomes include time to first opioid/alcohol ...

8. ojin.nursingworld.org ojin.nursingworld.org/table-of-contents/volume-25-2020/number-3-september-2020/development-of-a-novel-behavioral-intervention-for-opioid-use-disorders/

Development of a Novel Behavioral Intervention for Opioid ... Mindfulness-based relapse prevention for substance use disorders: A systematic review and meta-analysis. Journal of Addiction Medicine, 11(5), 386–396. doi ...

9. hhs.gov hhs.gov/sites/default/files/pmtf-final-report-2019-05-23.pdf

Pain Management Best Practices Inter-Agency Task Force ... OUD was previously classified as Opioid. Abuse or Opioid Dependence in DSM-IV. OUD has also been referred to as “opioid addiction.” Hyperalgesia ...