ACT + MBRP for Chronic Pain and Opioid Abuse
(POSITIVE Trial)
Recruiting in Palo Alto (17 mi)
+3 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: University of New Mexico
No Placebo Group
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.
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.
12345What 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.
678910Is 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.
1112131415Eligibility 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.
+2 more
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.
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: ACT + MBRPExperimental Treatment1 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 Control1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
San Francisco VA Health Care SystemSan Francisco, CA
New Mexico VA Healthcare SystemAlbuquerque, NM
Puget Sound VA Healthcare SystemTacoma, WA
University of New MexicoAlbuquerque, NM
Loading ...
Who Is Running the Clinical Trial?
University of New MexicoLead Sponsor
Johns Hopkins UniversityCollaborator
University of California, San FranciscoCollaborator
Seattle Institute for Biomedical and Clinical ResearchCollaborator
National Institute on Drug Abuse (NIDA)Collaborator
University of UtahCollaborator
Duke UniversityCollaborator
Vanderbilt UniversityCollaborator
Biomedical Research Institute of New MexicoCollaborator
Queen's University, BelfastCollaborator
References
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]Chronic pain and opioid use disorder (OUD) individually represent a risk to health and well-being. Concerningly, there is evidence that they are frequently co-morbid. While few treatments exist that simultaneously target both conditions, preliminary work has supported the feasibility of an integrated behavioral treatment targeting pain interference and opioid misuse. This treatment combined Acceptance and Commitment Therapy (ACT) and Mindfulness-Based Relapse Prevention (ACT+MBRP). This paper describes the protocol for the adequately powered efficacy study of this integrated treatment.
Creation of an algorithm for clinical decision support for treatment of opioid use disorder with buprenorphine in primary care. [2021]The treatment capacity for opioid use disorder (OUD) lags far behind the number of patients in need of treatment. Capacity is limited, in part, by the limited number of physicians who offer office based OUD treatment with buprenorphine. Measurement based care (MBC) has been proposed as a means to support primary care physicians in treating OUD. Here, we propose a set of measures and a clinical decision support algorithm to provide MBC for the treatment of OUD.
Sublingual Buprenorphine/Naloxone and Multi-Modal Management for High-Risk Chronic Pain Patients. [2021]Patients with chronic pain managed with opioid medications are at high risk for opioid overuse or misuse. West Virginia University (WVU) established a High-Risk Pain Clinic to use sublingual buprenorphine/naloxone (bup/nal) plus a multimodal approach to help chronic pain patients with history of Substance Use Disorder (SUD) or aberrant drug-related behavior. The objective of this study was to report overall retention rates and indicators of efficacy in pain control from approximately six years of High-Risk Pain Clinic data. A retrospective chart review was conducted for a total of 78 patients who enrolled in the High-Risk Pain Clinic between 2014 and 2020. Data gathered include psychiatric diagnoses, prescribed medications, pain score, buprenorphine/naloxone dosing, time in clinic, and reason for dismissal. A linear mixed effects model was used to assess the pain score from the Defense and Veterans Pain Rating Scale (DVPRS) and daily bup/nal dose across time. The overall retention of the High-Risk Pain Clinic was 41%. The mean pain score demonstrated a significant downward trend across treatment time (p < 0.001), while the opposite trend was seen with buprenorphine dose (p < 0.001). With the benefit of six years of observation, this study supports buprenorphine/naloxone as a safe and efficacious component of comprehensive chronic pain treatment in patients with SUD or high-risk of opioid overuse or misuse.
Consensus statement on office-based treatment of opioid dependence using buprenorphine. [2013]Buprenorphine and buprenorphine/naloxone (BUP) are newly approved for office-based treatment of opioid dependence. Federal and non-federal regulatory and monitoring agencies, national and international researchers, national professional organizations, researchers involved in monitoring, opioid treatment programs and the pharmaceutical industry met to synthesize and disseminate practical information to guide training, practice, monitoring, regulation and evaluation efforts with these medications. We performed a review of the literature, training curricula and practice guidelines and commissioned manuscripts describing recently completed, or still in progress, studies or field experiences with BUP treatment. A consensus process generated fifteen statements: (1) The federal government should collect baseline data on opioid-related deaths and morbidity to assess the effect of BUP on public health, (2) the patient limit for group practices should apply to individual physicians rather than group practices, (3 and 4) telephone and Internet-based physician and pharmacist support is needed, (5) clinicians who provide psychosocial services to opioid dependent patients should be informed of the role of BUP, (6) opioid-dependent patients should be instructed to present for induction in mild withdrawal, (7) the existing Center for Substance Abuse Treatment guidelines provide a reasonable induction protocol, (8) physicians should be prepared to use ancillary medications with BUP induction, (9) a physician or nurse must be available to the patient during the induction period, (10) concurrent counseling and support services are necessary, (11) detoxification without appropriate followup addiction treatment leads to rapid relapse and is not as effective as maintenance, (12) pregnant opioid-dependent women should be treated using good clinical practice including specialist addiction care and prenatal care, (13) BUP induction and withdrawal treatment may benefit from different designations for payment, (14) take-home medication options should be tailored to patients' needs, (15) there is a need for clinical and policy research in unique patient populations.
Pain Management in Patients With Opioid Use Disorder on Extended-release Buprenorphine: A Case Report. [2023]Persons with opioid use disorder (OUD) are receiving extended-release buprenorphine (ER-buprenorphine) for treatment of OUD. There are no clinical guidelines for management of patients with OUD on ER-buprenorphine experiencing acute or chronic pain. This case report describes 3 patient-involved, multidisciplinary approaches for pain management in various clinical scenarios, including a scheduled knee replacement, emergent surgery for an ischemic limb, and management of chronic pain from metastatic malignancy. These cases illustrate that adequate analgesia for patients who have received ER-buprenorphine is possible, and approaches can be individualized, with shared decision making between providers and patients addressing all barriers to optimize treatment outcomes. Options for acute pain management that can be considered include supplemental sublingual buprenorphine, nonopioid adjuncts, and short courses of full opioid agonists. Potential barriers that impact OUD and acute/chronic pain are provider bias, limited access to palliative care clinicians with addiction medicine training, and payor restrictions to adding sublingual buprenorphine for patients that are on ER-buprenorphine. Additional training for clinicians and other members of the health care team is recommended to improve patient-involved care of persons with OUD experiencing pain.
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]Evidence to date, while sparse, suggests that patients taking long-term opioids require special considerations and protections to prevent potential iatrogenic harms from opioid de-prescribing, such as increased pain or suffering. Following this study protocol, the EMPOWER study seeks to address multiple unmet needs of patients with chronic pain who desire to reduce long-term opioid therapy, and provide the clinical evidence on effective methodology.
Postmarketing studies program to assess the risks and benefits of long-term use of extended-release/long-acting opioids among chronic pain patients. [2020]Background: Among patients with chronic pain using long-term opioid therapy, the incidence of opioid abuse, addiction, overdose, and associated death are not well quantified. The range of estimates for these adverse outcomes varies drastically and may depend on how they are measured (i.e. study definitions of outcomes) and on patient characteristics and opioid-use factors (e.g. regimen, daily dose).Methods: Based on a review of the literature, the US Food and Drug Administration (FDA) required companies that manufacture and sell extended-release/long-acting (ER/LA) opioids conduct as a postmarketing requirement (PMR) a series of observational studies to estimate the rates of treatment-emergent misuse, abuse, addiction, overdose, and death using validated measures. The companies formed a consortium, the Opioid PMR Consortium (OPC), to conduct the studies.Results: The FDA initially requested four observational studies (a cohort study, a questionnaire validation study, a code validation study, and a doctor-shopping validation study), but in order to achieve the FDA's goals of the 4 studies, OPC and FDA agreed to 10 observational studies (a prospective cohort study, a retrospective database cohort study, three questionnaire validation studies, two code validation studies, and three doctor-shopping validation studies). The studies are continuing through 2020.Conclusions: A series of 10 observational studies was or are being conducted in response to the FDA's postmarketing requirement. All studies have been feasible to conduct, although a validated algorithm for measuring abuse and addiction in databases was not successful.
An update on the role of opioids in the management of chronic pain of nonmalignant origin. [2007]To summarize and reflect over primarily recent epidemiological and randomized controlled trials in opioid-treated chronic nonmalignant pain patients, focusing on effects, side effects, risks and long-term consequences of the treatment.
Pain management and prescription monitoring. [2019]Preventing diversion and abuse of prescription controlled substances while ensuring their availability for legitimate medical use is an important public health goal in the United States. In one approach to preventing and identifying drug diversion, 17 states have implemented prescription monitoring programs (PMPs) to monitor the prescribing of certain controlled substances. While PMPs are not intended to interfere with legitimate prescribing, some in the pain management community feel that they negatively affect prescribing for pain management. This article describes a collaborative project initiated by the Pain & Policy Studies Group that brought together regulatory and pain management representatives twice in 1998 to share perspectives and reconcile differing views on the effects of PMPs. The ultimate goals of this project are to provide accurate information to healthcare clinicians about PMPs, better define the balance between preventing drug diversion and providing pain management, and promote continued dialog and cooperation among the groups.
Longitudinal Treatment Outcomes for an Interdisciplinary Pain Rehabilitation Program: Comparisons of Subjective and Objective Outcomes on the Basis of Opioid Use Status. [2022]Chronic pain is a major public health concern, and widespread use of prescription opioids for chronic pain has contributed to the escalating problem of opioid use disorder. Interdisciplinary pain rehabilitation programs (IPRPs) can be highly effective in discontinuing opioids in patients with chronic pain while also improving functional status. This study sought to examine self-report and performance-based functional outcomes of 2 cohorts of patients enrolled in a 3-week IPRP: patients engaged in interdisciplinary pain treatment and physician-supervised opioid taper versus nonopioid users engaged in interdisciplinary treatment. Immediate and long-term treatment outcomes were assessed using a series of 2 (group: opioid use, no opioid use) × 2 (period: pretreatment, post-treatment) and 2 (group: opioid use, no opioid use) × 2 (period: pretreatment, 6 months post-treatment) mixed model analyses of variance. Group × Period interactions were nonsignificant whereas period effects were significant for all outcomes in directions indicating improvement (Ps
Adherence to legislation limiting opioid prescription duration following musculoskeletal injury. [2023]North Carolina had implemented legislation (Strengthen Opioid Misuse Prevention (STOP) Act) limiting opioid prescriptions to 5 days for acute pain and 7 days for post-operative pain. This study aimed to identify patient, prescriber, and facility characteristics associated with STOP Act adherence for patients with acute or post-surgical musculoskeletal (MSK) conditions.
[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]In the Federal Republic of Germany, strict regulations complicate the prescription of strong opioids to patients suffering from severe pain. In summer 1991 the German Association for the Study of Pain launched an initiative directed at simplification of the prescription requirements for such analgesics and submitted the suggestions to the ministries responsible. In the meantime a draft bill has been presented by the Ministry of Health, with due consideration for the main recommendations. For example, substantial increases in the permitted quantities of the individual narcotic analgesics and the prescription periods are planned. Moreover, the prescriptions are to be simpler to make out and certain exemptions have been specified by law. Acceptance of the bill by the political committees and its realization are expected in autumn 1992.
Complex Persistent Opioid Dependence with Long-term Opioids: a Gray Area That Needs Definition, Better Understanding, Treatment Guidance, and Policy Changes. [2021]The multitude of treatments available for tens of millions of US adults with moderate/severe chronic pain have limited efficacy. Long-term opioid therapy (LTOT) is a widely available option for controlling pain among patients with chronic pain refractory to other treatments. The recent recognition of LTOT inefficacy and complications has led to more frequent opioid tapering, which in turn has revealed its own set of complications. The occurrence of the same set of symptoms-worsening pain, declining function, and clinical instability-in contrasting contexts of LTOT ineffectiveness and opioid tapering has led to increasing recognition of the utility of complex persistent opioid dependence (CPOD), a clinically distinct but biologically similar state compared with opioid use disorder as an explanatory diagnosis/heuristic. Recent guidelines for LTOT tapering have incorporated buprenorphine treatment based on CPOD concepts as a recommended treatment for problems due to opioid tapering with limited supportive evidence. The increasing utilization of buprenorphine for both LTOT ineffectiveness and opioid tapering problems raises the urgent need for a review of the clinical definition, mechanisms, and treatment of CPOD and pertinent policies. In this manuscript, we discuss various issues related to CPOD that requires further clarification through research and policy development.
Understanding Buprenorphine for Use in Chronic Pain: Expert Opinion. [2021]An expert panel convened to reach a consensus on common misconceptions surrounding buprenorphine, a Schedule III partial µ-opioid receptor agonist indicated for chronic pain. The panel also provided clinical recommendations on the appropriate use of buprenorphine and conversion strategies for switching to buprenorphine from a full µ-opioid receptor agonist for chronic pain management.
Statewide Survey of Healthcare Professionals: Management of Patients With Chronic Noncancer Pain. [2015]Increased availability of prescription opioids has caused serious problems with misuse, abuse, and increased rates of morbidity and mortality. In response, Washington State enacted a law to regulate pain management and opioid prescribing practices.