Alcohol Use DisorderNCT07413458
Virtual Reality (VR) NATURE - Alcohol Use Disorder (AUD)
A study testing Virtual Reality (VR) -nature treatment and Survey completion in people with Alcohol Use Disorder, run by University of Michigan at 1 site in United States.
Trial summary
This pilot randomized clinical trial will evaluate the feasibility, acceptability, and preliminary effectiveness of immersive Virtual Reality (VR) nature intervention among adults with at least moderate depression symptoms enrolled in an intensive outpatient Program (IOP) for Alcohol Use Disorder (AUD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Virtual Reality (VR) -nature treatment and Survey completion
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Feb 2026to Feb 2028
- 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
- Individuals with a documented AUD diagnosis
- Individuals enrolled in an Intensive Outpatient Program (IOP) (First week enrollment or planned enrollment in Michigan Medicine's Addiction Treatment Services (UMATS) IOP)
- Individuals with a Patient Health Questionnaire (PHQ-9) score (≥10, moderate or greater depression symptoms)
Who cannot join
- Severe motion sickness or sensitivity to VR-induced nausea or dizziness (anticipated <10%), medical contraindications to VR use (e.g., seizure disorders, vestibular disorders, agoraphobia, claustrophobia, psychosis).
- Significant cognitive impairments that prevent provision of informed consent
- Suicidal ideation or plan after consultation with treating clinician
- Participants who require vision correction with glasses, unless vision correction is mild (±1), or the participant does not have prescription contact lenses.
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
University of Michigan
Ann Arbor, Michigan, 48109
Zee Petrie, 734-647-3357, petrieli@med.umich.edu
Hala Darwish, PhD
About this study
Official title: Virtual Reality Nature Immersion to Reduce Depression in People Engaged in Intensive Outpatient Alcohol Treatment
This pilot randomized clinical trial will evaluate the feasibility, acceptability, and preliminary effectiveness of immersive Virtual Reality (VR) nature intervention among adults with at least moderate depression symptoms enrolled in an intensive outpatient Program (IOP) for Alcohol Use Disorder (AUD).
The study hypotheses:
- VR-based nature immersion will be feasible, acceptable, and positively evaluated by participants
- Participants receiving the VR intervention will report greater reductions in symptoms of depression, anxiety, and stress compared to those receiving standard care alone
- Conditions
- Alcohol Use Disorder
- Being tested
- Virtual Reality (VR) -nature treatment, Survey completion
- Keywords
- Virtual Reality, Surveys
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality (VR) -nature treatmentDevice
Participants assigned to the VR intervention will engage in 5 to 30-minute (gradual increase in duration as tolerated to prevent motion sickness) -3 times per week, immersive VR nature sessions over 4 weeks, using the Apple Vision Pro and Explore POV app, alongside standardintensive outpatient program (IOP) care or other treatments they are receiving (e.g., additional counseling, psychiatry, etc.).
Survey completionBehavioural
All participants will complete surveys at various time-points (baseline - 9 weeks).
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality- (VR) nature treatment | Experimental | Will use VR for 4 weeks. Receives: Device: Virtual Reality (VR) -nature treatment; Behavioral: Survey completion |
| No VR - standard treatment - control group | Other | Participants will receive bi-weekly email reminders about participation in this study. Participants will be offered to try the VR headsets once participation is over for the randomized period (baseline to 8 weeks). Receives: Behavioral: Survey completion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment rates
Recruitment will be quantified by enrollment rates relative to eligibility screenings.
Measured: Recruitment period (approximately 18 months)
Attendance at scheduled VR sessions
Engagement will be assessed through attendance at scheduled VR sessions
Measured: 4 weeks of VR
Adherence to VR
Adherence will be measured based on participants meeting the 12-session target.
Measured: 4 weeks of VR
Percentage of participants that complete the entire study duration -VR
Retention will be evaluated through the percentage of participants who complete the entire study duration, targeting a benchmark of at least 8 of the 12 sessions.
Measured: 4 weeks of VR
Number of participants with documentation of informed consent completion
Measured: Recruitment period (Approximately 18 months)
The Virtual Reality Neuroscience Questionnaire (VRNQ)
The modified scale for this project uses 10 questions that participants will answer about the VR experience, rated from 1 (extremely low or extremely difficult) to 7 (extremely high or extremely easy). The scores range from 10 to 70, with higher scores indicating greater experience.
Measured: 4 weeks of VR
Changes in depression measured by Patient Health Questionnaire-9 (PHQ-9)
This is a 9-item self-report measure developed to assess the presence and severity of depression symptoms aligned with the diagnostic criteria for major depressive disorder (MDD). Each item on the PHQ-9 reflects a specific depression symptom experienced over the past two weeks, including anhedonia, mood disturbances, fatigue, and suicidal ideation. Participants rate items on a 4-point Likert scale ranging from 0 ("not at all") to 3 ("nearly every day"), resulting in a total score range of 0 to 27. Clinical severity classifications include minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19), and severe (20-27). A score of ≥10 is generally used as a cutoff for moderate depression, demonstrating optimal sensitivity and specificity.
Measured: Baseline, 4 weeks, 8 weeks
Changes in anxiety measured by the Generalized Anxiety Disorder-7 (GAD-7)
This is a self-administered 7-item screening tool specifically designed to assess the frequency and severity of symptoms characteristic of generalized anxiety disorder (GAD) over the preceding two weeks. Symptoms measured include nervousness, worry, restlessness, irritability, and fearfulness, which are rated by respondents using a 4-point Likert scale ranging from 0 ("not at all") to 3 ("nearly every day"). Scores range from 0 to 21, with severity categories typically classified as minimal anxiety (0-4), mild anxiety (5-9), moderate anxiety (10-14), and severe anxiety (≥15). A cutoff score of ≥10 is commonly used to identify clinically significant anxiety.
Measured: Baseline, 4 weeks, 8 weeks
Change on the Perceived stress scale (PSS-10)
This is a widely used psychological instrument for measuring the perception of stress. It comprises 10 items that assess how unpredictable, uncontrollable, and overloaded respondents find their lives. Each item is rated on a 5-point Likert scale ranging from "Never" (0) to "Very Often" (4). Items 4, 5, 7, and 8 are positively stated and are reverse scored. The total score ranges from 0 to 40, with higher scores indicating greater perceived stress. While there are no established cut-off scores, higher scores suggest higher levels of perceived stress.
Measured: Baseline, 4 weeks, 8 weeks
Change on the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Positive Affect
This is a psychometrically robust, 15-item measure specifically developed to assess positive emotional experiences or affective states over the past seven days. This PROMIS instrument focuses on capturing positive psychological constructs such as feelings of happiness, contentment, enthusiasm, and engagement with life. Participants rate each item using a 5-point Likert scale from 1 ("Not at All") to 5 ("Very Much"), with higher scores indicating greater levels of positive affect.
Measured: Baseline, 4 weeks, 8 weeks
Change on the PROMIS Applied Cognition Short form v.1.0
This is a concise, validated 8-item measure designed to assess participants' perceived cognitive deficits, regardless of disease type. This PROMIS instrument focuses on participants' perceptions of their mental acuity, concentration, verbal and nonverbal memory, verbal fluency, and perceived changes in their cognitive functions. Participants rate each item on a 5-point Likert scale from 1 ("Not At All") to 5 ("Very Much"), with higher scores indicating greater cognitive dysfunction.
Measured: Baseline, 4 weeks, 8 weeks
Change on the Ruminative Responses Scale
This is a validated and reliable 10-item scale that measures a participant's way of coping with repetitive and self-reflective moods. This is a shortened version of the Response Style Questionnaire and has been shortened to focus more on reflection and brooding, as compared to general depression. Participants rate each item from 1 ("Almost Never") to 4 ("Almost Always"), with higher scores indicating a greater level of rumination.
Measured: Baseline, 4 weeks, 8 weeks
Change on the alcohol use disorders identification test (AUDIT)
This is a well-validated, standardized instrument developed by the World Health Organization for screening hazardous alcohol consumption, harmful drinking patterns, and potential alcohol dependence. This tool consists of 10 items assessing alcohol consumption frequency, quantity, binge drinking behaviors, dependence symptoms, and related negative consequences. Scores range from 0 to 40, with higher scores indicating greater alcohol use severity: scores of 8 or higher suggest hazardous drinking patterns, while scores of 20 or more indicate probable dependence.
Measured: Baseline, 4 weeks, 8 weeks
Hardware and software-related issues
The technical feasibility will be measured by tracking hardware and software-related issues, with acceptability ratings of ≥75%.
Measured: 4 weeks of VR
Change on the Drug Abuse Screening Test-10 (DAST-10)
This is a brief, validated self-report measure designed to identify problematic use of substances other than alcohol. It consists of 10 items assessing drug use frequency, associated consequences, interpersonal difficulties, and impairment resulting from substance use behaviors. Total scores range from 0 to 10, with higher scores indicating a greater severity of drug-related problems: scores of 3-5 suggest moderate risk, and scores of 6 or higher indicate substantial drug abuse risk warranting further clinical evaluation.
Measured: Baseline, 4 weeks, 8 weeks
Qualitative interviews
Semi-structured qualitative interviews will be conducted individually with 10 randomly selected participants at 4 weeks to explore subjective experiences with the VR intervention. Each interview is anticipated to take approximately 30-40 minutes.
Measured: 4 weeks
Study Dropout rates calculated as the proportion of enrolled participants that do not complete the Week 8 assessment visit (or the final planned study assessment)
Dropout rate will be calculated as the proportion of enrolled participants who do not complete the Week 8 assessment visit (or the final planned study assessment) for any reason. The numerator is the number of participants who withdraw, are lost to follow-up, are discontinued by the study team, or otherwise fail to complete the Week 8 assessment. The denominator is the total number of participants enrolled and consented at baseline. Dropout will also be summarized by randomized arm. Higher values indicate worse retention (higher attrition).
Measured: Baseline - 8 weeks
Reasons for dropouts will be summarized as count and percentaged by overall by arm
Drop-out reasons will be collected at the time of withdrawal, if possible, using a brief standardized exit reason will be coded into predefined categories and summarized as count and percentaged overall by arm [ VR- tolerability, time demands, other treatment factors, technology issues, safety concerns, cybersickness, lost to follow up, other] If multiple reasons are provided, the study team will identify a primary reason.
Measured: Baseline - 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start16 Feb 2026
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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 will be randomized to one of the two arms/groups (N=25 in each group).
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hala Darwish, University of Michigan
- Investigators
- Hala Darwish, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07413458
- Sponsor's protocol ID
- HUM00283019
- Status last verified
- Mar 2026
- First submitted
- 29 Jan 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Nature Immersion to Reduce Depression in People Engaged in Intensive Outpatient Alcohol Treatment
- ClinicalTrials.gov ID
- NCT07413458
- Acronym / sponsor ID
- HUM00283019
- Conditions
- Alcohol Use Disorder
- Keywords
- Virtual Reality, Surveys
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 16 Feb 2026 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 17 Feb 2026 (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.
This pilot randomized clinical trial will evaluate the feasibility, acceptability, and preliminary effectiveness of immersive Virtual Reality (VR) nature intervention among adults with at least moderate depression symptoms enrolled in an intensive outpatient Program (IOP) for Alcohol Use Disorder (AUD).
The study hypotheses:
- VR-based nature immersion will be feasible, acceptable, and positively evaluated by participants
- Participants receiving the VR intervention will report greater reductions in symptoms of depression, anxiety, and stress compared to those receiving standard care alone
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized to one of the two arms/groups (N=25 in each group).
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality- (VR) nature treatment | Experimental | Device: Virtual Reality (VR) -nature treatment, Behavioral: Survey completionWill use VR for 4 weeks. |
| No VR - standard treatment - control group | Other | Behavioral: Survey completionParticipants will receive bi-weekly email reminders about participation in this study. Participants will be offered to try the VR headsets once participation is over for the randomized period (baseline to 8 weeks). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals with a documented AUD diagnosis
- Individuals enrolled in an Intensive Outpatient Program (IOP) (First week enrollment or planned enrollment in Michigan Medicine's Addiction Treatment Services (UMATS) IOP)
- Individuals with a Patient Health Questionnaire (PHQ-9) score (≥10, moderate or greater depression symptoms)
Key exclusion criteria (4 listed)
- Severe motion sickness or sensitivity to VR-induced nausea or dizziness (anticipated <10%), medical contraindications to VR use (e.g., seizure disorders, vestibular disorders, agoraphobia, claustrophobia, psychosis).
- Significant cognitive impairments that prevent provision of informed consent
- Suicidal ideation or plan after consultation with treating clinician
- Participants who require vision correction with glasses, unless vision correction is mild (±1), or the participant does not have prescription contact lenses.
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 |
|---|---|---|
| Virtual Reality (VR) -nature treatmentParticipants assigned to the VR intervention will engage in 5 to 30-minute (gradual increase in duration as tolerated to prevent motion sickness) -3 times per week, immersive VR nature sessions over 4 weeks, using the Apple Vision Pro and Explore POV app, alongside standardintensive outpatient program (IOP) care or other treatments they are receiving (e.g., additional counseling, psychiatry, etc.). | Device | Virtual Reality- (VR) nature treatment |
| Survey completionAll participants will complete surveys at various time-points (baseline - 9 weeks). | Behavioural | No VR - standard treatment - control group, Virtual Reality- (VR) nature treatment |
Primary outcome
Enrollment rates
Time frame: Recruitment period (approximately 18 months)
Recruitment will be quantified by enrollment rates relative to eligibility screenings.
Attendance at scheduled VR sessions
Time frame: 4 weeks of VR
Engagement will be assessed through attendance at scheduled VR sessions
Adherence to VR
Time frame: 4 weeks of VR
Adherence will be measured based on participants meeting the 12-session target.
Percentage of participants that complete the entire study duration -VR
Time frame: 4 weeks of VR
Retention will be evaluated through the percentage of participants who complete the entire study duration, targeting a benchmark of at least 8 of the 12 sessions.
Number of participants with documentation of informed consent completion
Time frame: Recruitment period (Approximately 18 months)
The Virtual Reality Neuroscience Questionnaire (VRNQ)
Time frame: 4 weeks of VR
The modified scale for this project uses 10 questions that participants will answer about the VR experience, rated from 1 (extremely low or extremely difficult) to 7 (extremely high or extremely easy). The scores range from 10 to 70, with higher scores indicating greater experience.
Changes in depression measured by Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline, 4 weeks, 8 weeks
This is a 9-item self-report measure developed to assess the presence and severity of depression symptoms aligned with the diagnostic criteria for major depressive disorder (MDD). Each item on the PHQ-9 reflects a specific depression symptom experienced over the past two weeks, including anhedonia, mood disturbances, fatigue, and suicidal ideation. Participants rate items on a 4-point Likert scale ranging from 0 ("not at all") to 3 ("nearly every day"), resulting in a total score range of 0 to 27. Clinical severity classifications include minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19), and severe (20-27). A score of ≥10 is generally used as a cutoff for moderate depression, demonstrating optimal sensitivity and specificity.
Changes in anxiety measured by the Generalized Anxiety Disorder-7 (GAD-7)
Time frame: Baseline, 4 weeks, 8 weeks
This is a self-administered 7-item screening tool specifically designed to assess the frequency and severity of symptoms characteristic of generalized anxiety disorder (GAD) over the preceding two weeks. Symptoms measured include nervousness, worry, restlessness, irritability, and fearfulness, which are rated by respondents using a 4-point Likert scale ranging from 0 ("not at all") to 3 ("nearly every day"). Scores range from 0 to 21, with severity categories typically classified as minimal anxiety (0-4), mild anxiety (5-9), moderate anxiety (10-14), and severe anxiety (≥15). A cutoff score of ≥10 is commonly used to identify clinically significant anxiety.
Change on the Perceived stress scale (PSS-10)
Time frame: Baseline, 4 weeks, 8 weeks
This is a widely used psychological instrument for measuring the perception of stress. It comprises 10 items that assess how unpredictable, uncontrollable, and overloaded respondents find their lives. Each item is rated on a 5-point Likert scale ranging from "Never" (0) to "Very Often" (4). Items 4, 5, 7, and 8 are positively stated and are reverse scored. The total score ranges from 0 to 40, with higher scores indicating greater perceived stress. While there are no established cut-off scores, higher scores suggest higher levels of perceived stress.
Change on the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Positive Affect
Time frame: Baseline, 4 weeks, 8 weeks
This is a psychometrically robust, 15-item measure specifically developed to assess positive emotional experiences or affective states over the past seven days. This PROMIS instrument focuses on capturing positive psychological constructs such as feelings of happiness, contentment, enthusiasm, and engagement with life. Participants rate each item using a 5-point Likert scale from 1 ("Not at All") to 5 ("Very Much"), with higher scores indicating greater levels of positive affect.
Change on the PROMIS Applied Cognition Short form v.1.0
Time frame: Baseline, 4 weeks, 8 weeks
This is a concise, validated 8-item measure designed to assess participants' perceived cognitive deficits, regardless of disease type. This PROMIS instrument focuses on participants' perceptions of their mental acuity, concentration, verbal and nonverbal memory, verbal fluency, and perceived changes in their cognitive functions. Participants rate each item on a 5-point Likert scale from 1 ("Not At All") to 5 ("Very Much"), with higher scores indicating greater cognitive dysfunction.
Change on the Ruminative Responses Scale
Time frame: Baseline, 4 weeks, 8 weeks
This is a validated and reliable 10-item scale that measures a participant's way of coping with repetitive and self-reflective moods. This is a shortened version of the Response Style Questionnaire and has been shortened to focus more on reflection and brooding, as compared to general depression. Participants rate each item from 1 ("Almost Never") to 4 ("Almost Always"), with higher scores indicating a greater level of rumination.
Change on the alcohol use disorders identification test (AUDIT)
Time frame: Baseline, 4 weeks, 8 weeks
This is a well-validated, standardized instrument developed by the World Health Organization for screening hazardous alcohol consumption, harmful drinking patterns, and potential alcohol dependence. This tool consists of 10 items assessing alcohol consumption frequency, quantity, binge drinking behaviors, dependence symptoms, and related negative consequences. Scores range from 0 to 40, with higher scores indicating greater alcohol use severity: scores of 8 or higher suggest hazardous drinking patterns, while scores of 20 or more indicate probable dependence.
Hardware and software-related issues
Time frame: 4 weeks of VR
The technical feasibility will be measured by tracking hardware and software-related issues, with acceptability ratings of ≥75%.
Change on the Drug Abuse Screening Test-10 (DAST-10)
Time frame: Baseline, 4 weeks, 8 weeks
This is a brief, validated self-report measure designed to identify problematic use of substances other than alcohol. It consists of 10 items assessing drug use frequency, associated consequences, interpersonal difficulties, and impairment resulting from substance use behaviors. Total scores range from 0 to 10, with higher scores indicating a greater severity of drug-related problems: scores of 3-5 suggest moderate risk, and scores of 6 or higher indicate substantial drug abuse risk warranting further clinical evaluation.
Qualitative interviews
Time frame: 4 weeks
Semi-structured qualitative interviews will be conducted individually with 10 randomly selected participants at 4 weeks to explore subjective experiences with the VR intervention. Each interview is anticipated to take approximately 30-40 minutes.
Study Dropout rates calculated as the proportion of enrolled participants that do not complete the Week 8 assessment visit (or the final planned study assessment)
Time frame: Baseline - 8 weeks
Dropout rate will be calculated as the proportion of enrolled participants who do not complete the Week 8 assessment visit (or the final planned study assessment) for any reason. The numerator is the number of participants who withdraw, are lost to follow-up, are discontinued by the study team, or otherwise fail to complete the Week 8 assessment. The denominator is the total number of participants enrolled and consented at baseline. Dropout will also be summarized by randomized arm. Higher values indicate worse retention (higher attrition).
Reasons for dropouts will be summarized as count and percentaged by overall by arm
Time frame: Baseline - 8 weeks
Drop-out reasons will be collected at the time of withdrawal, if possible, using a brief standardized exit reason will be coded into predefined categories and summarized as count and percentaged overall by arm [ VR- tolerability, time demands, other treatment factors, technology issues, safety concerns, cybersickness, lost to follow up, other] If multiple reasons are provided, the study team will identify a primary reason.
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 27 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Hala Darwish, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality (VR) -nature treatment and Survey completion in people with Alcohol Use Disorder, run by University of Michigan 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 3 inclusion and 4 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 27 Mar 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 Zee Petrie (734-647-3357, petrieli@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment rates (time frame: Recruitment period (approximately 18 months)). The study lists 18 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 27 Mar 2026.