Substance Use DisorderPATHNCT06580457
Personalized Approach to Healthy Use and Recovery (PATH) Trial
A study testing Personal Causal Model + Personalized Feedback in people with Substance Use Disorder, run by VA Office of Research and Development at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Use Disorder
- What is being tested?
- Personal Causal Model + Personalized Feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2025to 29 Mar 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417-2309
Brittany Stevenson, PhD, 612-467-3023, Brittany.Stevenson@va.gov
Kelvin O Lim, MD, (612) 467-3323, kelvin.lim@va.gov
About this study
Official title: Understanding and Treating Substance Use Disorder and Comorbid Conditions in Veterans' Real-Life Settings
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.
Read the detailed description
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.
- Conditions
- Substance Use Disorder
- Being tested
- Personal Causal Model + Personalized Feedback
- Keywords
- substance use disorder, precision medicine, ecological momentary assessment
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personal Causal Model + Personalized FeedbackBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Receive the personal causal model with a 1-hour, live clinical feedback session. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 4-, 8-, and 12-week follow-ups
Secondary outcomes (3)
PTSD Symptoms
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.
Measured: 4-, 8-, and 12-week follow-ups
Anxiety Symptoms
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.
Measured: 4-, 8-, and 12-week follow-ups
Depression Symptoms
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.
Measured: 4-, 8-, and 12-week follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start1 Oct 2025
- Primary completion1 Oct 2029 (estimated)
- Study completion29 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisorderStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized to either intervention or control group
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Emory University, University of Minnesota
- Responsible party
- Sponsor
- Investigators
- Brittany Stevenson, PhD, Principal investigator, Minneapolis VA Health Care System, Minneapolis, MN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06580457
- Sponsor's protocol ID
- NURA-009-24S
- Other IDs
- 1IK2CX002716
- Acronym
- PATH
- Status last verified
- Jan 2026
- First submitted
- 29 Aug 2024
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: A deidentified, anonymized dataset will be created and shared.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding and Treating Substance Use Disorder and Comorbid Conditions in Veterans' Real-Life Settings
- ClinicalTrials.gov ID
- NCT06580457
- Acronym / sponsor ID
- PATH / NURA-009-24S
- Conditions
- Substance Use Disorder
- Keywords
- substance use disorder, precision medicine, ecological momentary assessment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Emory University, University of Minnesota
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Oct 2029 (estimated)
- Study completion
- 29 Mar 2030 (estimated)
- First posted
- 30 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomized to either intervention or control group
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Personal Causal Model + Personalized FeedbackReceive the personal causal model with a 1-hour, live clinical feedback session. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Inclusion criteria for this study are intended to include most Veterans with SUD
- inclusion criteria are current probable SUD as indicated by:
Key exclusion criteria (5 listed)
- exclusion criteria are being under the influence of a judgment-impairing substance at the time of consent (e.g., cannabis, alcohol, illicit opioids)
- being legally compelled to complete treatment
- or being under civil commitment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personal Causal Model + Personalized FeedbackReceive 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. | Behavioural | Intervention |
Primary outcome
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.
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.
3 secondary outcomes
PTSD Symptoms
Time frame: 4-, 8-, and 12-week follow-ups
Anxiety Symptoms
Time frame: 4-, 8-, and 12-week follow-ups
Depression Symptoms
Time frame: 4-, 8-, and 12-week follow-ups
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: No. A deidentified, anonymized dataset will be created and shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brittany Stevenson, PhD principal investigator
Minneapolis VA Health Care System, Minneapolis, MN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personal Causal Model + Personalized Feedback in people with Substance Use Disorder, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brittany Stevenson, PhD ((612) 467-3023, Brittany.Stevenson@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Substance use (time frame: 4-, 8-, and 12-week follow-ups). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.