Clinical trial NCT06063499: HMP for Addictions Study
Official title: Healthy Minds Program for Veterans With Opioid Use Disorder on Buprenorphine Maintenance Treatment: A Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Opioid Use Disorder
Opioid Use
Buprenorphine Dependence
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Center for Healthy Minds
First posted: 2023-10-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this clinical trial is to see whether the Healthy Minds Program for Addictions could be used to help veterans with moderate-severe opioid use disorder and post-traumatic stress disorder stay on buprenorphine maintenance treatment.

Participants will be asked to complete a six-week program consisting of 6 weekly, 2-hour in-person group sessions, as well as assessments before the start of the sessions.

Detailed description: This is a 6-week, single-arm, single-center pilot study of the acceptability and efficacy of an adaptation of the Healthy Minds Program for Veterans with opioid use disorder on buprenorphine maintenance treatment.

Following the Screening Visit, eligible subjects will complete 6 in-person sessions over the course of 2 months. The first session will be an introductory session introducing the basics of the program. After the introductory session, there will be four weekly sessions, each dedicated to a different domain of the program - awareness, connection, insight, and purpose. Participants will be encouraged to practice daily anywhere from 5 to 30 minutes from a set of practices that will be available to them on a password protected website. The intervention will end with a closing session where participants will have the opportunity to reflect on their experience of the program and share feedback. Weekly sessions will be held in person and will be facilitated by an MD, PhD Psychiatrist and Neuroscientist with 8 years of mindfulness practice together with a certified Peer Support Specialist.

Eligibility criteria: Inclusion Criteria:

* Individuals at least 18 years of age
* English-speaking
* Veterans
* Ability to understand and willingness to sign a written informed consent document
* Have access to a smartphone, tablet, or computer with internet connection to access recordings for home practice
* Ability and willingness to attend all 6 session of the study, and to complete all assessment questionnaires
* Verified Post-Traumatic Stress Disorder (PTSD) according to DSM-5 criteria
* On buprenorphine maintenance treatment for Opioid use disorder (OUD) for a minimum of 3 months

Exclusion Criteria:

* Regular daily meditation practice for past 6 months or regular weekly meditation practice for past 12 months
* Attended a meditation retreat or a yoga/body practice retreat with a significant meditation component
* Previous use of Healthy Minds Program app
* Current suicidal intent and/or high self-injury risk, as determined from the interview
* Current psychopathology that interferes with study participation as assessed by interview

Primary outcomes:
measure: Retention in treatment
timeFrame: Through study completion, up to 4 months
measure: Change in predictors of relapse and recovery
timeFrame: Baseline, 3 weeks, 6 weeks
Secondary outcomes:
measure: Change in psychological distress - perceived stress
timeFrame: Baseline, 3 weeks, 6 weeks
measure: Change in psychological distress - anxiety and depression
timeFrame: Baseline, 3 weeks, 6 weeks
measure: Change in PTSD symptoms
timeFrame: Baseline, 3 weeks, 6 weeks
measure: Change in well-being
timeFrame: Baseline, 3 weeks, 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of Wisconsin, Madison
name: Timothy Juergens, MD
role: PRINCIPAL_INVESTIGATOR
References: