Personalized Approach to Healthy Use and Recovery (PATH) Trial

NCT06580457 | Recruiting DMC

• 2 other identifiers: NURA-009-24S1IK2CX002716
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

An important part of substance use treatment for many people is learning what triggers their substance use and urges, and how they can better manage those triggers. In this study, the investigators will generate a model for each individual that shows likely causal links between their substance use, urges, and comorbid symptoms (e.g., anxiety, depression, and PTSD), and the investigators will examine these models as a group to draw conclusions about common causes for substance use (and recovery) among Veterans with substance use disorders. The investigators will also test whether receiving a personal model and clinical feedback improves substance use disorder and comorbid symptom outcomes. Results will include both patient-reported and statistically-determined causes of substance use for individuals and groups, clinical impact of a personalized model and feedback session, and participant feedback about the relevance of this study and intervention.

Conditions

Substance Use Disorder

Keywords

substance use disorder; precision medicine; ecological momentary assessment

Outcome Measures

Primary Outcomes (2)

• Substance use

  Substance use will be measured as number of days each substance was used in the past 30 days using National Survey on Drug Use and Health questions. Substances measured are nicotine, alcohol, cannabis, cocaine/crack, heroin, hallucinogens, inhalants, methamphetamine, pain relievers, tranquilizers, sedatives, and prescription stimulants. For alcohol, we will also obtain number of drinks consumed on each day, and will analyze whether average number of drinks per drinking day has changed during each follow-up period.

  4-, 8-, and 12-week follow-ups

• Substance-related problems

  Substance-related problems will be measured for the past month using the Alcohol Use Disorders Identification Test (AUDIT) and Drug Use Disorders Identification Test (DUDIT). Scores range from 0 to 40. Scores will be analyzed for changes at each follow-up point.

  4-, 8-, and 12-week follow-ups

Secondary Outcomes (3)

• PTSD Symptoms

  4-, 8-, and 12-week follow-ups

• Anxiety Symptoms

  4-, 8-, and 12-week follow-ups

• Depression Symptoms

  4-, 8-, and 12-week follow-ups

Study Arms (2)

Intervention

EXPERIMENTAL

Receive the personal causal model with a 1-hour, live clinical feedback session.

Behavioral: Personal Causal Model + Personalized Feedback

Control

NO INTERVENTION

No clinical feedback session. Personal causal models will be provided at the end of the study for those who wish to receive them.

Interventions

Personal Causal Model + Personalized Feedback BEHAVIORAL

Receive a personal causal model of one's personalized causes of substance use/urges, along with a 1-hour, live clinical feedback session to suggest how to apply these insights to one's own recovery.

Intervention

Eligibility Criteria

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

You may qualify if:

• a clinical score on the alcohol use disorders identification test (AUDIT) or drug use disorders identification test (DUDIT)
• past-month substance use
• a reliable access to a smartphone, tablet, or other device with capability of accessing and completing surveys throughout the day
• this will exclude those who are currently completing inpatient treatment

You may not qualify if:

• participants will be invited to return another day
• being legally compelled to complete treatment
• or being under civil commitment
• due to lack of ability to give autonomous consent in these situations

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Emory University: collaborator
• University of Minnesota: collaborator

Study Sites (1)

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417-2309, United States

RECRUITING

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Brittany Stevenson, PhD

  Minneapolis VA Health Care System, Minneapolis, MN

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brittany Stevenson, PhD

CONTACT

(612) 467-3023; Brittany.Stevenson@va.gov

Kelvin O Lim, MD

CONTACT

(612) 467-3323; kelvin.lim@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Participants are randomized to either intervention or control group

Study Record Dates

• First Submitted: August 29, 2024
• First Posted: August 30, 2024
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): March 29, 2030
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)