ACT + Mindfulness for Chronic Pain & Opioid Use Disorder
(HOPE Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of New Mexico
Must be taking: Buprenorphine
Disqualifiers: Schizophrenia, Delusional disorder, others
No Placebo Group
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.12345
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.23567
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.278910
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.
See 2 more
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.
Trial 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) (Behavioral Intervention)
- Enhance Usual Care (EUC) (Behavioral Intervention)
Trial OverviewThis 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
2Treatment groups
Experimental Treatment
Active Control
Group I: ACT + MBRP InterventionExperimental Treatment1 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 Control1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of MichiganAnn Arbor, MI
University of New MexicoAlbuquerque, NM
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Who Is Running the Clinical Trial?
University of New MexicoLead Sponsor
National Institute on Drug Abuse (NIDA)Collaborator
Wake Forest UniversityCollaborator
University of MichiganCollaborator
References
An Ultra-Brief Mindfulness-Based Intervention for Patients in Treatment for Opioid Addiction with Buprenorphine: A Primary Care Feasibility Pilot Study. [2020]Objectives: To demonstrate the feasibility and acceptability of a brief mindfulness-based intervention taught by physicians for patients with opioid addiction and to determine if the intervention reduces likelihood of relapse or treatment failure within 6 months. Design: A prospective, feasibility, single-group, cohort pilot study. Setting: A Family Medicine teaching clinic serving a mixed urban and rural population in Bangor, Maine. Subjects: Adult patients initiating outpatient treatment for opioid addiction with buprenorphine (N = 40). Interventions: Study physicians conducted a 10- to 12-min education session for all patients starting treatment during the enrollment period, including a 5-min mindfulness exercise. Enrolled subjects received an MP3 player loaded with six mindfulness audio exercises (5-19 min) and were instructed to practice at least 5 min daily and record their practice in a logbook. Outcome measures: Acceptability and subjective usefulness to recovery were evaluated at 2, 4, and 6 months of follow-up, with qualitative analysis of themes in recorded poststudy interviews. Logbook entries and tablet-based surveys provided data on home mindfulness practice, classified as "high" or "low." Relapse or treatment failure was documented. Results: Feasibility and acceptability were demonstrated with 82% enrollment and 100%, 97%, and 90% completion of follow-up visits at 2, 4, and 6 months, respectively, among those still in treatment. Sustained positive impressions of the intervention and exercises remained at 6 months. Relapse or treatment failure was reduced in the "high" practice uptake group compared with "low" practice uptake (11% vs. 42%, p = 0.033). Conclusions: In contrast to more intensive 8-week models of meditation training, this study demonstrates that even a brief single training session can induce sustained home meditation practice that subjectively helped patients in recovery for opioid addiction and was associated with lower risk of relapse. Brief mindfulness-based interventions may be useful to increase access to mindfulness training in this population.
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.
Study protocol for a randomized controlled trial of mindfulness-based relapse prevention for opioid use disorders. [2021]The opioid misuse epidemic has reached a crisis level in the United States. Though mindfulness-based relapse prevention (MBRP) has been shown as effective in treating substance use disorders, there is limited research on its application to opioid use disorders specifically, and there is a need to understand the underlying mechanisms. This paper outlines a protocol for a randomized controlled trial of MBRP for opioid use disorders. MBRP is a group aftercare program that integrates mindfulness skills training with cognitive-behavioral relapse prevention strategies. We will recruit 240 participants who have completed opioid use disorder treatment, and randomize them to an 8-week MBRP group intervention or treatment as usual (TAU) control group. The TAU control group will complete the intervention after 8 weeks. Assessments will take place at baseline, 8 weeks, and 16 weeks. The primary outcome is frequency of opioid use. The secondary outcomes include craving and withdrawal symptoms, time to first opioid use, adherence to medication-assisted treatment plans, perceived stress, quality of life, posttraumatic stress symptoms, and chronic pain. We will also examine the following potential moderators and correlates of intervention outcomes: comorbid diagnoses, life events history, and MBRP intervention adherence. In addition, we will examine the following mediators of intervention outcome: mindfulness skills, emotion regulation skills, executive functioning skills, savoring, and positive and negative affect. This study will contribute to the evidence base regarding MBRP's efficacy in reducing opioid use, as well as contribute to the understanding of the causal mechanisms and factors that modify treatment outcome for MBRP for substance use disorders.
Testing Mindfulness-Based Relapse Prevention with Medications for Opioid Use Disorder Among Adults in Outpatient Therapy: a Quasi-experimental Study. [2022]This study aimed to explore the effectiveness of mindfulness-based relapse prevention (MBRP) with individuals receiving medication for opioid use disorder (MOUD) in a naturalistic, open-ended outpatient group treatment setting.
Mindfulness-based relapse prevention for cannabis regular users: Preliminary outcomes of a randomized clinical trial. [2022]Mindfulness-based approaches have shown their effectiveness in caring for patients with substance use disorders (SUD). Mindfulness-based relapse prevention (MBRP) integrates practices from mindfulness-based interventions and cognitive-behavioral relapse prevention (RP) approaches. This article presents the preliminary results of a study that measures the effectiveness of an MBRP protocol for volunteer cannabis users willing to reduce or stop their consumptions. Twenty cannabis users were randomly assigned to either receive an eight-week outpatient MBRP program or treatment as usual (TAU). Cannabis use was assessed weekly through the timeline follow back (TLFB). Eighty percent of individuals received MBRP treatment and 60% of individuals received TAU completed treatment. Preliminary results did not find significant difference at the end of treatment (week 8) regarding the number of joints smoked. Despite the absence of any significant difference between the two groups, the contribution of mindfulness in the caring of SUD seems encouraging and promising. Many MBRP group participants reported qualitative changes in the way they consumed. This study will be continued in order to evaluate the effectiveness of MBRP on a larger number of subjects.
Efficacy of mindfulness-based relapse prevention in veterans with substance use disorders: Design and methodology of a randomized clinical trial. [2021]Mindfulness based interventions have been shown to be efficacious in treating depression, anxiety, pain and substance use disorders (SUDs). Mindfulness-Based Relapse Prevention (MBRP) is an intervention that integrates cognitive-behavioral relapse prevention and mindfulness meditation practices, in an 8-week, manualized group intervention designed to treat SUDs by helping patients regulate negative emotional states and reactive behavior. This paper describes the rationale, study design and methodology of a two-site, randomized controlled trial comparing MBRP to 12-Step Facilitation (TSF) in military Veterans following completion of intensive outpatient treatment for SUDs. The 8 weeks of 90-min, group-based MBRP or TSF sessions are followed by 3-, 6- and 10-month follow-up period with assessments of alcohol/drug use, quality of life, depression, anxiety, mindfulness and other functional outcomes, such as employment. The primary hypothesis is that MBRP will be significantly better than TSF in promoting recovery and prevention of relapse to substance use in a military Veteran population. The secondary hypothesis is that MBRP will lead to greater improvements in quality of life, depression/anxiety, and functional outcomes, such as employment. This study is designed to provide information about the use of group-based MBRP as a relapse prevention strategy for military Veterans who have completed an intensive SUD clinical treatment program. Clinical Trial Identifier: NCT02326363.
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]A mindfulness-based intervention that reduces comorbid pain, anxiety, and substance use during office-based opioid treatment (OBOT) could enhance retention and prevent overdose. We conducted a pilot study of the Mindful Recovery OUD Care Continuum (M-ROCC), a 24-week trauma-informed program with a motivationally-sensitive curriculum.
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]Mindfulness-based interventions have a positive impact on pain, craving, and well-being in both patients with chronic pain and those with opioid use disorder (OUD). Although data are limited, mindfulness-based cognitive therapy (MBCT) might be a promising treatment for patients with chronic noncancer pain combined with OUD. The aim of this qualitative study was to explore the feasibility and process of change during MBCT in this particular population.
Feasibility and acceptability of mindful recovery opioid use care continuum (M-ROCC): A concurrent mixed methods study. [2023]As opioid overdose deaths increase, buprenorphine/naloxone (B/N) treatment is expanding, yet almost half of patients are not retained in B/N treatment. Mindfulness-based interventions (MBIs) designed to promote non-judgmental awareness of present moment experience may be complementary to B/N treatment and offer the potential to enhance retention by reducing substance use and addressing comorbid symptoms. In this pilot study, we examined the feasibility and acceptability of the Mindful Recovery OUD Care Continuum (M-ROCC), a trauma-informed, motivationally sensitive, 24-week MBI. Participants (N = 18) were adults with Opioid Use Disorder prescribed B/N. The study team conducted assessments of satisfaction, mindfulness levels, and home practice, as well as qualitative interviews at 4 and 24-weeks. M-ROCC was feasible in a sample with high rates of childhood trauma and comorbid psychiatric diagnoses with 89% of participants retained at 4-weeks and 72% at 24-weeks. Positive qualitative interview responses and a high rate of participants willing to refer a friend (100%) demonstrates program acceptability. Participant mindfulness increased from baseline to 24-weeks (β = 0.24, p = 0.001, d = 0.51), and increases were correlated with informal mindfulness practice frequency (r = 0.7, p
Integrated Behavioral Treatment for Veterans With Co-Morbid Chronic Pain and Hazardous Opioid Use: A Randomized Controlled Pilot Trial. [2021]Opioid prescription in the treatment of chronic pain is frequent and carries a risk of increased morbidity and mortality in a clinically significant number of patients, particularly those who are using opioids in a hazardous manner. Few treatment options are available that target both pain-related interference and hazardous opioid use among patients with chronic pain. In military Veterans, this issue is of particular importance as numerous reports indicate continued high rates of opioid prescription for chronic pain, as well as significant opioid-related problems. The overall aim of the present study was to determine the feasibility of an integrated psychosocial treatment in Veterans with chronic pain, who also have evidence of hazardous opioid use. To examine this aim, a random design was used to assess the feasibility and initial efficacy of integrating 2 empirically supported interventions: Acceptance and Commitment Therapy for chronic pain and Mindfulness Based Relapse Prevention for opioid misuse. Half of participants were randomized to the integrated treatment group and all participants received usual care through a Veteran's Administration co-occurring disorders medical clinic to treat chronic pain and opioid misuse. In total, 37 participants were randomized and included in intent-to-treat analyses and 32 individuals were included in per protocol analyses with 6-month follow-up serving as the primary study endpoint. Feasibility indicators included recruitment, retention, and treatment completion rates. Recruitment fell short of targeted enrollment, although retention and completion were excellent. Primary outcome measures were opioid misuse, pain interference, and pain behavior. Simultaneous multiple regression analyses controlled for pain duration, baseline opioid dose, and baseline value for outcome measures. Results of both the intent-to-treat and per protocol indicated a significant effect in favor of the integrated intervention for opioid misuse, pain interference, and pain behavior. Results support the feasibility of providing an integrated treatment for both opioid risk and pain interference. PERSPECTIVE: Opioid misuse occurs in some opioid-prescribed individuals with chronic pain. Few treatment options exist that target both pain interference and opioid misuse. This study examined feasibility and initial efficacy of an integrated behavioral treatment for Veterans. Feasibility was supported, except recruitment. Efficacy was supported compared to usual care.