HMP for Addictions Study

NCT06063499 | Withdrawn DMC

• 3 other identifiers: 2024-0247SMPH/PSYCHIATRY/PSYCHIATRYProtocol Version 6/30/23
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Opioid Use Disorder; Opioid Use; Buprenorphine Dependence

Outcome Measures

Primary Outcomes (2)

• Retention in treatment

  Number of participants who complete all 6 sessions, as measured through actual attendance.

  Through study completion, up to 4 months

• Change in predictors of relapse and recovery

  The Brief Addiction Monitor (BAM) is a 17-item, multidimensional, progress-monitoring instrument for patients in treatment for a substance use disorder (SUD). The BAM includes items that assess risk factors for substance use (scores 0-24, higher scores meaning more risk), protective factors that support sobriety (scores 0-24, higher scores meaning more protection), and drug and alcohol use (scores 0-12, higher scores meaning more use). The BAM produces composite scores for the three aforementioned domains.

  Baseline, 3 weeks, 6 weeks

Secondary Outcomes (4)

• Change in psychological distress - perceived stress

  Baseline, 3 weeks, 6 weeks

• Change in psychological distress - anxiety and depression

  Baseline, 3 weeks, 6 weeks

• Change in PTSD symptoms

  Baseline, 3 weeks, 6 weeks

• Change in well-being

  Baseline, 3 weeks, 6 weeks

Study Arms (1)

6 weeks of sessions

EXPERIMENTAL

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

Behavioral: Healthy Minds Program for Addictions

Interventions

Healthy Minds Program for Addictions 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.

6 weeks of sessions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Center for Healthy Minds: collaborator

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Timothy Juergens, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2023
• First Posted: October 2, 2023
• Study Start: May 1, 2025
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share