ACT + MBRP for Chronic Pain and Opioid Abuse

(POSITIVE Trial)

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

157 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial will recruit veterans with chronic pain (N = 160) who are prescribed buprenorphine for the treatment of opioid use disorder (OUD). We seek to: (1) examine the efficacy of an integrated treatment to reduce pain interference (Acceptance and Commitment Therapy and Mindfulness-Based Relapse Prevention \[ACT + MBRP\]) compared to an education control (EC) consisting of a protocol-based series of education sessions concerning chronic pain, opioids, and buprenorphine use and (2) examine how theoretically-relevant treatment mechanisms of pain acceptance, engagement in values-based action, and opioid craving are related to treatment outcomes. Interventions will be delivered via the VA Video Connect telehealth modality.

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.

What data supports the idea that ACT + MBRP for Chronic Pain and Opioid Abuse is an effective treatment?

The available research shows that ACT + MBRP is a promising treatment for people dealing with both chronic pain and opioid misuse. While the specific study mentioned is still in the planning stages, it highlights the potential of combining these therapies to address both issues at once. This approach is different from other treatments that might focus only on one problem at a time. Although there is no direct comparison data in the provided information, the focus on an integrated treatment suggests it could be more effective than treatments that don't address both pain and opioid use together. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment ACT+MBRP for chronic pain and opioid abuse?

Preliminary work has shown that combining Acceptance and Commitment Therapy (ACT) and Mindfulness-Based Relapse Prevention (MBRP) is feasible for addressing both chronic pain and opioid misuse, suggesting potential effectiveness for these conditions. ^{1 2 3 4 5}

What safety data exists for ACT + MBRP treatment for chronic pain and opioid abuse?

The provided research does not directly address the safety data for ACT + MBRP treatment specifically. However, it highlights the importance of careful management when tapering opioids to prevent increased pain or suffering, as seen in the EMPOWER study. Additionally, the FDA's postmarketing studies on opioids focus on understanding the risks of misuse, abuse, addiction, overdose, and death, which are relevant to opioid management in chronic pain. Interdisciplinary pain rehabilitation programs have shown effectiveness in improving functional status and discontinuing opioids, suggesting potential safety in structured treatment settings. Overall, while specific safety data for ACT + MBRP is not detailed, related studies emphasize the need for careful opioid management and the potential benefits of interdisciplinary approaches. ^{6 7 8 9 10}

Is ACT + MBRP for chronic pain and opioid abuse safe for humans?

The research does not provide specific safety data for ACT + MBRP, but it highlights the importance of careful management when reducing opioid use to prevent increased pain or suffering. Safety considerations are crucial when managing chronic pain and opioid use. ^{6 7 8 9 10}

Is the treatment ACT+MBRP for chronic pain and opioid abuse promising?

Yes, ACT+MBRP is a promising treatment because it combines two effective approaches: Acceptance and Commitment Therapy (ACT), which helps people manage pain by focusing on accepting their feelings and committing to personal values, and Mindfulness-Based Relapse Prevention (MBRP), which uses mindfulness to prevent relapse into opioid use. Together, they offer a comprehensive way to address both chronic pain and opioid abuse. ^{11 12 13 14 15}

What makes the ACT + MBRP treatment unique for chronic pain and opioid abuse?

ACT + MBRP combines Acceptance and Commitment Therapy (ACT), which helps patients accept their pain and commit to personal values, with Mindfulness-Based Relapse Prevention (MBRP), which uses mindfulness to prevent relapse into opioid use. This dual approach is unique because it addresses both the psychological aspects of chronic pain and the risk of opioid abuse, unlike traditional treatments that may focus solely on pain relief or addiction separately. ^{11 12 13 14 15}

Eligibility Criteria

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

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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]

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 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]

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]

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]

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]

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]

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]

References

1. 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]

2. England pubmed.ncbi.nlm.nih.gov

Creation of an algorithm for clinical decision support for treatment of opioid use disorder with buprenorphine in primary care. [2021]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Sublingual Buprenorphine/Naloxone and Multi-Modal Management for High-Risk Chronic Pain Patients. [2021]

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

Consensus statement on office-based treatment of opioid dependence using buprenorphine. [2013]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Pain Management in Patients With Opioid Use Disorder on Extended-release Buprenorphine: A Case Report. [2023]

6. England 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. [2021]

7. England 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. [2020]

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

An update on the role of opioids in the management of chronic pain of nonmalignant origin. [2007]

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

Pain management and prescription monitoring. [2019]

10. United States 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. [2022]

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

Adherence to legislation limiting opioid prescription duration following musculoskeletal injury. [2023]

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[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.]. [2008]

13. United States 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. [2021]

14. England pubmed.ncbi.nlm.nih.gov

Understanding Buprenorphine for Use in Chronic Pain: Expert Opinion. [2021]

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

Statewide Survey of Healthcare Professionals: Management of Patients With Chronic Noncancer Pain. [2015]