Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06580457

Personalized Approach to Healthy Use and Recovery (PATH) Trial

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417-2309, United States

Location status: Recruiting

Location contact

Brittany Stevenson, PhD

CONTACT

[email protected]

612-467-3023

Brittany Stevenson, PhD

PRINCIPAL_INVESTIGATOR

Kelvin O Lim, MD

CONTACT

[email protected]

(612) 467-3323

About this study

Substance use disorders (SUDs) are very common in Veterans, with 1 in 3 Veterans meeting criteria for a SUD each year. SUDs typically occur in the context of other comorbid conditions, such as depressive disorders, post-traumatic stress disorder (PTSD), or anxiety disorders. For Veterans who have comorbid conditions and SUD, treatment outcomes are worse than those who have SUD only. The investigators propose that the factors leading to poor SUD treatment outcomes in this population are not adequately understood and, based on preliminary research, vary widely by individual. The investigators propose to measure SUD and comorbid symptoms multiple times daily in Veterans with SUD to characterize the connections between SUD and comorbid conditions for each individual. N = 74 Veterans with SUD will complete personalized 4-week ecological momentary assessment (EMA) protocols measuring SUD and comorbid symptoms, as well as personalized items relevant to each Veteran's presentation. Personalized models will be estimated from each Veteran's EMA data using causal discovery analyses. Veterans will be randomized to either intervention or control groups. The intervention group will receive their personal causal models along with an hour-long clinical feedback session based on their model. The investigators will also attempt to integrate the models into any ongoing treatment and deliver follow-up reminders of key insights from their models to the intervention participants throughout the remainder of the study. Follow-up measures will assess the impact of receiving this personalized intervention. A subset of N = 24 Veterans who were in the intervention group will be invited to share their feedback on the acceptability, relevance, and usefulness of the EMA protocol, personal models, and clinical feedback, as well as thoughts on the factors that support recovery versus problematic substance use. Specific aims are: 1) to identify the momentary causes of substance use and urges for Veterans with SUD, both individually and as a group, 2) Examine the clinical impact of receiving personal causal models of substance use and urges, and 3) Refine the personal causal models and clinical feedback to improve acceptability and relevance to Veterans. This project will advance understanding of day-to-day maintenance mechanisms for problematic substance use in Veterans with SUD. This study will create causal models of substance and comorbid symptoms at the individual level and test the impact of receiving clinical feedback based on these models. Aims will be accomplished through a training plan that involves conducting VA clinical trials, using causal discovery, and using qualitative analyses to leverage feedback from participants.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Inclusion criteria for this study are intended to include most Veterans with SUD
  • inclusion criteria are current probable SUD as indicated by:
  • 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

Exclusion criteria

  • exclusion criteria are being under the influence of a judgment-impairing substance at the time of consent (e.g., cannabis, alcohol, illicit opioids)
  • 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

Treatment and study plan

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.

Primary outcomes

  1. Substance use

    Time frame: 4-, 8-, and 12-week follow-ups

    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.

  2. Substance-related problems

    Time frame: 4-, 8-, and 12-week follow-ups

    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.

Secondary outcomes

  1. PTSD Symptoms

    Time frame: 4-, 8-, and 12-week follow-ups

    PTSD Checklist 5 or PCL-5 measures past 30 day PTSD symptoms. Scores range from 0 to 80. Scores will be analyzed for changes at each follow-up point.

  2. Anxiety Symptoms

    Time frame: 4-, 8-, and 12-week follow-ups

    Generalized Anxiety Disorder (GAD-7) measures anxiety symptoms over the last 2 weeks. Scores range from 0 to 21. Scores will be analyzed for changes at each follow-up point.

  3. Depression Symptoms

    Time frame: 4-, 8-, and 12-week follow-ups

    Beck Depression Inventory (BDI) measures depression symptoms over the last month. Scores range from 0 to 63. Scores will be analyzed for changes at each follow-up point.

Study contacts

Contact information is provided by the study sponsor or research team.

Brittany Stevenson, PhD

CONTACT

[email protected]

(612) 467-3023

Kelvin O Lim, MD

CONTACT

[email protected]

(612) 467-3323

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Collaborators

  • Emory University
  • University of Minnesota

Registry information

Official study title

Understanding and Treating Substance Use Disorder and Comorbid Conditions in Veterans' Real-Life Settings

Acronym: PATH

Important dates

Study start
2025
Primary completion
2029
Study completion
2030
First posted
Aug 30, 2024
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.