HMP for Addictions Study

NCT ID: NCT06063499

Last Updated: 2025-02-19

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-31
• Study Completion Date: 2025-08-31

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.

Conditions

Opioid Use Disorder; Opioid Use; Buprenorphine Dependence

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

6 weeks of sessions

Participants will be asked to attend 6 2-hour weekly in-person sessions

Group Type: EXPERIMENTAL

Healthy Minds Program for Addictions

Intervention Type: BEHAVIORAL

The Healthy Minds Program for Addictions is a 6-week, hybrid version of the original Healthy Minds Program (HMP), in which all lessons are adapted from the original lessons available in the app and delivered exclusively in person over weekly group sessions. The HMP has \>100 guided audio practices that address 4 constituents of wellbeing: awareness, connection, insight, and purpose. Study participants will have access to specific practices from the HMP that are particularly relevant to the needs of populations with substance use disorders and trauma.

Interventions

Healthy Minds Program for Addictions

The Healthy Minds Program for Addictions is a 6-week, hybrid version of the original Healthy Minds Program (HMP), in which all lessons are adapted from the original lessons available in the app and delivered exclusively in person over weekly group sessions. The HMP has \>100 guided audio practices that address 4 constituents of wellbeing: awareness, connection, insight, and purpose. Study participants will have access to specific practices from the HMP that are particularly relevant to the needs of populations with substance use disorders and trauma.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Center for Healthy Minds

OTHER

Sponsor Role: collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Timothy Juergens, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Other Identifiers

SMPH/PSYCHIATRY/PSYCHIATRY

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol Version 6/30/23

Identifier Type: OTHER

Identifier Source: secondary_id

2024-0247

Identifier Type: -

Identifier Source: org_study_id