Personalized Feedback for Substance Use Disorder

(PATH Trial)

Overseen By Brittany Stevenson, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Inpatient treatment, Civil commitment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

74 Participants Needed

Trial Summary

What is the purpose of this 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.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Personal Causal Model + Personalized Feedback for Substance Use Disorder?

Research shows that personalized feedback interventions are effective in reducing alcohol consumption and related problems, particularly among college students. These interventions have been shown to be reliably effective at reducing harmful alcohol misuse, suggesting that personalized feedback could be beneficial for substance use disorders as well. ^{1 2 3 4 5}

Is Personalized Feedback for Substance Use Disorder safe for humans?

There is limited safety information specifically for Personalized Feedback for Substance Use Disorder, but general safety reporting in substance use disorder trials has been challenging and burdensome, suggesting that detailed safety data may not be readily available. ^{6 7 8 9 10}

How does the treatment 'Personal Causal Model + Personalized Feedback' differ from other treatments for substance use disorder?

This treatment is unique because it combines personalized feedback, which helps individuals understand their substance use patterns compared to others, with a personal causal model that may help them identify and address the underlying causes of their behavior. This approach is more tailored to the individual compared to standard treatments, which may not provide such personalized insights. ^{1 2 3 11 12}

Research Team

Brittany Stevenson, PhD

Principal Investigator

Minneapolis VA Health Care System, Minneapolis, MN

Eligibility Criteria

This trial is for veterans with substance use disorders who want to understand and manage their triggers. It's important that participants have co-occurring conditions like anxiety, depression, or PTSD. The study requires them to be open to receiving personalized feedback based on a model created from their experiences.

Inclusion Criteria

Inclusion criteria for this study are intended to include most Veterans with SUD

Current probable SUD as indicated by a clinical score on the alcohol use disorders identification test (AUDIT) or drug use disorders identification test (DUDIT)

Reliable access to a smartphone, tablet, or other device with capability of accessing and completing surveys throughout the day (excluding those who are currently completing inpatient treatment)

Exclusion Criteria

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)

I am not under legal obligation to complete treatment or civil commitment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Ecological Momentary Assessment (EMA)

Participants complete personalized 4-week EMA protocols measuring SUD and comorbid symptoms

4 weeks

Daily assessments

Intervention

Intervention group receives personal causal models with a 1-hour clinical feedback session

1 week

1 visit (in-person or virtual)

Follow-up

Participants are monitored for changes in substance use, depression, PTSD, and anxiety symptoms

12 weeks

Follow-up assessments at 4, 8, and 12 weeks

Treatment Details

Interventions

• Personal Causal Model + Personalized Feedback

Trial Overview The study tests if creating a personal causal model of an individual's substance use and providing feedback can help improve the management of substance use disorder and related symptoms. Participants will receive models showing potential causes for their behavior and recovery patterns.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

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

Group II: Control Active Control 1 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 Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

University of Minnesota

Collaborator

Trials

1,459

Recruited

1,623,000+

Emory University

Collaborator

Trials

1,735

Recruited

2,605,000+

Findings from Research

Individuals who consume higher amounts of alcohol are more likely to choose to receive personalized feedback about their drinking habits, with 85% of participants consistently opting in across two time points.

Receiving feedback led to a small reduction in peak alcohol consumption among heavy drinkers over a 30-day period, suggesting that personalized interventions may help reduce drinking intensity, although further research is needed to confirm these findings in more diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Who Opts In to Alcohol Feedback and How Does That Impact Behavior? A Pilot Trial. Boness, CL., Helle, AC., Miller, MB., et al.[2023]

Personalized drinking feedback interventions (PFIs) are effective in reducing harmful alcohol misuse among college students, based on a comprehensive review of 41 studies.

Interventions that included components like decisional balance, practical costs, and risk-limiting strategies showed significantly larger effects, highlighting the importance of these elements in developing effective feedback-based interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalized feedback interventions for college alcohol misuse: an update of Walters & Neighbors (2005). Miller, MB., Leffingwell, T., Claborn, K., et al.[2022]

In a study involving 121 participants from a community substance use disorder clinic, personalized feedback interventions did not show any significant benefits in reducing alcohol consumption compared to standard pre-treatment assessment procedures.

The results indicated that feedback-based brief interventions were ineffective in improving outcomes such as drinking frequency, intensity, or motivation for treatment among individuals with substance use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a Feedback-Based Brief Intervention to Reduce Alcohol Use in Community Substance Use Disorders. Worden, BL., McCrady, BS.[2021]

In a study involving 118 clinicians across 20 outpatient substance abuse treatment clinics, a semiautomated patient feedback system was tested over 12 weeks, but it did not show any significant impact on reducing drug and alcohol use among over 1,500 patients.

The intervention also failed to improve secondary outcomes related to therapeutic alliance and clinician job satisfaction, suggesting that the feedback system may need alternative approaches to enhance clinical effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled study of a web-based performance improvement system for substance abuse treatment providers. Crits-Christoph, P., Ring-Kurtz, S., McClure, B., et al.[2021]

A new standardized strategy for reporting adverse events (AEs) and serious adverse events (SAEs) in substance use disorder (SUD) clinical trials was developed, which aims to reduce the reporting burden while maintaining safety monitoring.

In a review of 17 SUD trials involving 6737 participants, the new strategy showed a significant reduction in irrelevant safety event reporting, leading to a more consistent safety assessment system tailored to the risks associated with specific trial interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies for safety reporting in substance abuse trials. Lindblad, R., Campanella, M., Styers, D., et al.[2013]

A study of 1244 opioid-dependent individuals found that those who stopped naltrexone treatment experienced significantly higher overdose rates (39 overdoses per 100 person-years) compared to those who left agonist treatments, indicating a critical risk period immediately after stopping naltrexone.

Overall, individuals who left any pharmacotherapy for opioid dependence had much higher rates of serious adverse events and deaths (six per 100 person-years) compared to when they were in treatment, highlighting the need for ongoing support and risk education after treatment cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serious adverse events in the Australian National Evaluation of Pharmacotherapies for Opioid Dependence (NEPOD). Digiusto, E., Shakeshaft, A., Ritter, A., et al.[2022]

The MOSES method, which incorporates the timing and severity of adverse events, was found to be more accurate than the traditional CTCAE system in predicting the impact of symptoms on quality of life in cervical cancer patients undergoing radiotherapy, with a study involving 300 patients.

In comparing two radiotherapy techniques, 3DCRT showed a higher cumulative MOSES score than IMRT, indicating potentially greater late toxicity, despite no significant difference in overall gastrointestinal toxicity grades between the two methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Months and Severity Score (MOSES) in a Phase III trial (PARCER): A new comprehensive method for reporting adverse events in oncology clinical trials. Ranjan, N., Chopra, S., Mangaj, A., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Who Opts In to Alcohol Feedback and How Does That Impact Behavior? A Pilot Trial. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Personalized feedback interventions for college alcohol misuse: an update of Walters & Neighbors (2005). [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of web-based decisional balance feedback and personalized normative feedback for college drinkers. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of a Feedback-Based Brief Intervention to Reduce Alcohol Use in Community Substance Use Disorders. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

A randomized controlled study of a web-based performance improvement system for substance abuse treatment providers. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Strategies for safety reporting in substance abuse trials. [2013]

7. England pubmed.ncbi.nlm.nih.gov

Serious adverse events in the Australian National Evaluation of Pharmacotherapies for Opioid Dependence (NEPOD). [2022]

8. United States pubmed.ncbi.nlm.nih.gov

The Yale algorithm. Special workshop--clinical. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Causes of Outcome Learning: a causal inference-inspired machine learning approach to disentangling common combinations of potential causes of a health outcome. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Months and Severity Score (MOSES) in a Phase III trial (PARCER): A new comprehensive method for reporting adverse events in oncology clinical trials. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Enhancing the efficacy of computerized feedback interventions for college alcohol misuse: An exploratory randomized trial. [2018]

12. United States pubmed.ncbi.nlm.nih.gov

The efficacy of Personalized Normative Feedback interventions across addictions: A systematic review and meta-analysis. [2021]