Alcohol DrinkingNCT04110756
ChangeGradients: Promoting Adolescent Health Behavior Change
A study testing ChangeGradients in people with Alcohol Drinking and Self Efficacy, run by University of California, San Francisco at 1 site in United States.
Trial summary
As most adolescents visit a healthcare provider once a year, health behavior change interventions linked to clinic-based health information technologies hold significant promise for improving healthcare quality and subsequent behavioral health outcomes for adolescents (Baird, 2014, Harris, 2017). Read more about this study
- Who is it for?
- Ages 15 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking, Self Efficacy, Adolescent Behavior
- What is being tested?
- ChangeGradients
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2024to 30 Sep 2027
- 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 15 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Adolescents between the ages of 15 and 17 years of age
- Report current alcohol use
- Presenting for a well-visit at UCSF Pediatric primary care clinics (the Mt. Zion Pediatric Primary Care Practices at UCSF and The Adolescent/Young Adult Clinic at UCSF)
Who cannot join
- Non-English speakers
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 California San Francisco Adolescent and Young Adult Medicine Clinic
San Francisco, California, 94107
Elizabeth M Ozer, PhD, 415-502-4851, elizabeth.ozer@ucsf.edu
Alison S Giovanelli, PhD, 805-405-0772, alison.giovanelli@ucsf.edu
About this study
Official title: Promoting Adolescent Health Behavior Change With Clinically Integrated Sample-Efficient Policy Gradient Methods
As most adolescents visit a healthcare provider once a year, health behavior change interventions linked to clinic-based health information technologies hold significant promise for improving healthcare quality and subsequent behavioral health outcomes for adolescents (Baird, 2014, Harris, 2017). Recognizing the potential to leverage recent advances in machine learning and interactive narrative environments, the investigators are now well positioned to design health behavior change systems that extend the reach of clinicians to realize significant impacts on behavior change for adolescent preventive health.
The proposed project centers on the design, development, and evaluation of a clinically-integrated health behavior change system for adolescents. CHANGEGRADIENTS will introduce an innovative reinforcement learning-based feedback loop in which adolescent patients interact with personalized behavior change interactive narratives that are dynamically personalized and realized in a rich narrative-centered virtual environment. CHANGEGRADIENTS will iteratively improve its behavior change models using policy gradient methods for Reinforcement Learning (RL) designed to optimize adolescents' achieved behavior change outcomes. This in turn will enable CHANGEGRADIENTS to generate more effective behavior change narratives, which will then lead to further improved behavior change outcomes. With a focus on risky behaviors and an emphasis on alcohol use, adolescents will interact with CHANGEGRADIENTS to develop an experiential understanding of the dynamics and consequences of their alcohol use decisions. The proposed project holds significant transformative potential for (1) producing theoretical and practical advances in how to realize significant impacts on adolescent health behavior change through novel interactive narrative technologies integrated with policy-based reinforcement learning, (2) devising sample-efficient policy gradient methods for RL that produce personalized behavior change experiences by integrating theoretically based models of health behavior change with data-driven models of interactive narrative generation, and (3) promoting new models for integrating personalized health behavior change technologies into clinical care that extend the effective reach of clinicians.
Read the detailed description
STUDY AIMS:
- Design, develop, and iteratively refine a policy-based reinforcement learning behavior change system for preventive adolescent health (Part 1).
II. Investigate the impact of a clinically integrated sample-efficient policy gradient-based behavior change system on adolescent behavior (Part 2).
The project will culminate with an investigation of the behavioral effects of the CHANGEGRADIENTS system using adolescent patients recruited from two outpatient primary care clinics within the UCSF Department of Pediatrics: Mt. Zion Pediatrics and the Adolescent/Young Adult Clinic. It is hypothesized that adolescents who interact with CHANGEGRADIENTS will reduce number of days of alcohol use, reduce binge drinking, and increase self-efficacy to engage in healthy behavior and avoid risky substance use.
It is anticipated that CHANGEGRADIENTS will provide a testbed for a broad range of health behavior change research and serve as the foundation for next generation personalized preventive healthcare through computationally enabled behavior change that is designed to be tightly integrated into clinical practice workflow. By taking advantage of the high degree of adaptive interactivity offered by its personalized behavior change environment, CHANGEGRADIENTS holds significant potential for creating compelling interactions that promote self-efficacy and engagement in healthy lifestyle behaviors to prevent cancer through improving cancer-related behaviors and risk factors.
PART 1 of the study (Focus Group) has closed to enrollment.
PART 2 of the study (Randomized Clinical Trial) is planned for enrollment upon finalization of data collected in Part 1.
- Conditions
- Alcohol Drinking, Self Efficacy, Adolescent Behavior, Risk-Taking, Cancer
- Being tested
- ChangeGradients
- Keywords
- Alcohol- Prevention/Control, Adolescent behavior, Video games- psychology
- Medical subject headings
- Alcohol Drinking, Adolescent Behavior, Risk-Taking, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChangeGradientsBehavioural
Also called CHANGEGRADIENTS system
CHANGEGRADIENTS is an interactive web-based tool which includes narrative-centered behavior change experiences that are dynamically generated.
| Study group | Role | What they receive |
|---|---|---|
| Treatment (ChangeGradients) | Experimental | Adolescent participants will be introduced to the intervention through a brief introductory video trailer during their clinic visit and receive a link that enables them to engage with CHANGEGRADIENTS interactive narratives at home over a course of four weeks (i.e., one per week) on a personal computing device (e.g., laptop or tablet). Receives: Behavioral: ChangeGradients |
| No Intervention (Usual Care) | No intervention | Participants will receive usual care at the clinic. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean scores on assessment of Alcohol Use
Standard validated questions taken from the "Alcohol and other Drug Use" scale of the Youth Risk Behavior Surveillance Survey (CDC surveillance system that monitors adolescent risk behavior) will be administered. Measures include quantity and frequency of use and safety (drinking and driving), Current use of alcohol measured by quantity and frequency of use in the past 30 days (Centers for Disease Control and Prevention, 2018). Scale ranges vary based on questions and questions are scored individually. Responses to questions about alcohol use in general (past 12 months and ever) are scored as No = 0 and Yes = 1. Values on questions about alcohol use in the past 30 days are scored on a scale from 0-7, with higher values corresponding to greater alcohol consumption. Questions about drinking and driving are scored on a scale from 0-5 with higher numbers corresponding to more frequent instances of driving/being driven by others after alcohol was consumed.
Measured: 30 days
Mean score on a Self-efficacy tool developed by Drs Elizabeth Ozer and Dr. Albert Bandura
Self-efficacy will be measured using a tool developed by Drs Elizabeth Ozer and Dr. Albert Bandura designed for this study. The tool assesses confidence in avoiding drinking in various scenarios. Participants are asked to rate level of confidence in drinking avoidance across various situations. Responses are rated on a scale of 0 to 10, with a rating of 0 indicating 'not at all confident', a rating of 5 indicating 'moderately confident', and rating of 10 indicating t 'completely confident'. Scenarios include: "When a close friend offers you a drink," and, "When you feel depressed or nervous." Scores on this assessment are calculated by summing participant responses and dividing by the number of questions to obtain a mean self-efficacy score.
Measured: 30 days
Quality of Care: Adolescent Report of the Visit (AROV)
The Adolescent Report of the Visit (AROV) is a validated measure to assess the quality of care delivered to adolescents (Ozer, 2004), which has been utilized in clinics nationally and internationally (Sanci, 2015). The investigators are specifically using questions from this measure assessing provider rates of screening and counseling adolescents for alcohol use during adolescent visits. All questions are scored separately on a binary scale, with response scoring as No = 0 and Yes = 1. An answer of Yes to any item indicates higher quality of care.
Measured: 1 day, immediately following baseline clinic visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start12 Feb 2024
- Primary completion31 Jul 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- North Carolina State University, National Cancer Institute (NCI), UniHealth Foundation
- Responsible party
- Sponsor
- Investigators
- Elizabeth Ozer, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04110756
- Sponsor's protocol ID
- 19-28893
- Other IDs
- R01CA247705
- Status last verified
- Oct 2026
- First submitted
- 10 Sep 2019
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data may be shared with research collaborators during the course of the study
Publications
Baird A, Nowak S. Why primary care practices should become digital health information hubs for their patients. BMC Fam Pract. 2014 Nov 25;15:190. doi: 10.1186/s12875-014-0190-9.
PubMed 25421733Harris SK, Aalsma MC, Weitzman ER, Garcia-Huidobro D, Wong C, Hadland SE, Santelli J, Park MJ, Ozer EM. Research on Clinical Preventive Services for Adolescents and Young Adults: Where Are We and Where Do We Need to Go? J Adolesc Health. 2017 Mar;60(3):249-260. doi: 10.1016/j.jadohealth.2016.10.005. Epub 2016 Dec 20.
PubMed 28011064Ozer EM, Bandura A. Mechanisms governing empowerment effects: a self-efficacy analysis. J Pers Soc Psychol. 1990 Mar;58(3):472-86. doi: 10.1037//0022-3514.58.3.472.
PubMed 2324938Ozer EM, Adams SH, Orrell-Valente JK, Wibbelsman CJ, Lustig JL, Millstein SG, Garber AK, Irwin CE Jr. Does delivering preventive services in primary care reduce adolescent risky behavior? J Adolesc Health. 2011 Nov;49(5):476-82. doi: 10.1016/j.jadohealth.2011.02.011. Epub 2011 Jun 8.
PubMed 22018561Sanci L, Chondros P, Sawyer S, Pirkis J, Ozer E, Hegarty K, Yang F, Grabsch B, Shiell A, Cahill H, Ambresin AE, Patterson E, Patton G. Responding to Young People's Health Risks in Primary Care: A Cluster Randomised Trial of Training Clinicians in Screening and Motivational Interviewing. PLoS One. 2015 Sep 30;10(9):e0137581. doi: 10.1371/journal.pone.0137581. eCollection 2015.
PubMed 26422235Ozer EM, Adams SH, Lustig JL, Millstein SG, Wibbelsman CJ, Babb J. The effect of preventive services on adolescent behavior (abstract). Pediatric Research. 2004;53(suppl. 4, pt. 2):265A.
Ozer EM. The impact of childcare responsibility and self-efficacy on the psychological health of working mothers. Psychology of Women Quarterly. 1995;19:315-35.
Ozer E, Rowe J, Tebb K, Culbertson K, Berna M, Jasik C, et al. A self-adaptive personalized behavior change system for adolescent preventive care. The Indian Journal of Pediatrics, Special Supplement The International Association for Adolescent Health, 11th World Congress on Adolescent Health, 27-29 October, 2017, New Delhi, India2017. p. SS-1.
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Adolescent Health Behavior Change With Clinically Integrated Sample-Efficient Policy Gradient Methods
- ClinicalTrials.gov ID
- NCT04110756
- Acronym / sponsor ID
- 19-28893
- Conditions
- Alcohol Drinking, Self Efficacy, Adolescent Behavior, Risk-Taking, Cancer
- Keywords
- Alcohol- Prevention/Control, Adolescent behavior, Video games- psychology
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- North Carolina State University, National Cancer Institute (NCI), UniHealth Foundation
- Study start
- 12 Feb 2024 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 1 Oct 2019 (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.
As most adolescents visit a healthcare provider once a year, health behavior change interventions linked to clinic-based health information technologies hold significant promise for improving healthcare quality and subsequent behavioral health outcomes for adolescents (Baird, 2014, Harris, 2017). Recognizing the potential to leverage recent advances in machine learning and interactive narrative environments, the investigators are now well positioned to design health behavior change systems that extend the reach of clinicians to realize significant impacts on behavior change for adolescent preventive health.
The proposed project centers on the design, development, and evaluation of a clinically-integrated health behavior change system for adolescents. CHANGEGRADIENTS will introduce an innovative reinforcement learning-based feedback loop in which adolescent patients interact with personalized behavior change interactive narratives that are dynamically personalized and realized in a rich narrative-centered virtual environment. CHANGEGRADIENTS will iteratively improve its behavior change models using policy gradient methods for Reinforcement Learning (RL) designed to optimize adolescents' achieved behavior change outcomes. This in turn will enable CHANGEGRADIENTS to generate more effective behavior change narratives, which will then lead to further improved behavior change outcomes. With a focus on risky behaviors and an emphasis on alcohol use, adolescents will interact with CHANGEGRADIENTS to develop an experiential understanding of the dynamics and consequences of their alcohol use decisions. The proposed project holds significant transformative potential for (1) producing theoretical and practical advances in how to realize significant impacts on adolescent health behavior change through novel interactive narrative technologies integrated with policy-based reinforcement learning, (2) devising sample-efficient policy gradient methods for RL that produce personalized behavior change experiences by integrating theoretically based models of health behavior change with data-driven models of interactive narrative generation, and (3) promoting new models for integrating personalized health behavior change technologies into clinical care that extend the effective reach of clinicians.
Detailed description
STUDY AIMS:
- Design, develop, and iteratively refine a policy-based reinforcement learning behavior change system for preventive adolescent health (Part 1).
II. Investigate the impact of a clinically integrated sample-efficient policy gradient-based behavior change system on adolescent behavior (Part 2).
The project will culminate with an investigation of the behavioral effects of the CHANGEGRADIENTS system using adolescent patients recruited from two outpatient primary care clinics within the UCSF Department of Pediatrics: Mt. Zion Pediatrics and the Adolescent/Young Adult Clinic. It is hypothesized that adolescents who interact with CHANGEGRADIENTS will reduce number of days of alcohol use, reduce binge drinking, and increase self-efficacy to engage in healthy behavior and avoid risky substance use.
It is anticipated that CHANGEGRADIENTS will provide a testbed for a broad range of health behavior change research and serve as the foundation for next generation personalized preventive healthcare through computationally enabled behavior change that is designed to be tightly integrated into clinical practice workflow. By taking advantage of the high degree of adaptive interactivity offered by its personalized behavior change environment, CHANGEGRADIENTS holds significant potential for creating compelling interactions that promote self-efficacy and engagement in healthy lifestyle behaviors to prevent cancer through improving cancer-related behaviors and risk factors.
PART 1 of the study (Focus Group) has closed to enrollment.
PART 2 of the study (Randomized Clinical Trial) is planned for enrollment upon finalization of data collected in Part 1.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment (ChangeGradients) | Experimental | Behavioral: ChangeGradientsAdolescent participants will be introduced to the intervention through a brief introductory video trailer during their clinic visit and receive a link that enables them to engage with CHANGEGRADIENTS interactive narratives at home over a course of four weeks (i.e., one per week) on a personal computing device (e.g., laptop or tablet). |
| No Intervention (Usual Care) | No intervention | –Participants will receive usual care at the clinic. |
Who may qualify
- Ages
- 15 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Adolescents between the ages of 15 and 17 years of age
- Report current alcohol use
- Presenting for a well-visit at UCSF Pediatric primary care clinics (the Mt. Zion Pediatric Primary Care Practices at UCSF and The Adolescent/Young Adult Clinic at UCSF)
Key exclusion criteria (1 listed)
- Non-English speakers
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 |
|---|---|---|
| ChangeGradientsAlso: CHANGEGRADIENTS systemCHANGEGRADIENTS is an interactive web-based tool which includes narrative-centered behavior change experiences that are dynamically generated. | Behavioural | Treatment (ChangeGradients) |
Primary outcome
Mean scores on assessment of Alcohol Use
Time frame: 30 days
Standard validated questions taken from the "Alcohol and other Drug Use" scale of the Youth Risk Behavior Surveillance Survey (CDC surveillance system that monitors adolescent risk behavior) will be administered. Measures include quantity and frequency of use and safety (drinking and driving), Current use of alcohol measured by quantity and frequency of use in the past 30 days (Centers for Disease Control and Prevention, 2018). Scale ranges vary based on questions and questions are scored individually. Responses to questions about alcohol use in general (past 12 months and ever) are scored as No = 0 and Yes = 1. Values on questions about alcohol use in the past 30 days are scored on a scale from 0-7, with higher values corresponding to greater alcohol consumption. Questions about drinking and driving are scored on a scale from 0-5 with higher numbers corresponding to more frequent instances of driving/being driven by others after alcohol was consumed.
Mean score on a Self-efficacy tool developed by Drs Elizabeth Ozer and Dr. Albert Bandura
Time frame: 30 days
Self-efficacy will be measured using a tool developed by Drs Elizabeth Ozer and Dr. Albert Bandura designed for this study. The tool assesses confidence in avoiding drinking in various scenarios. Participants are asked to rate level of confidence in drinking avoidance across various situations. Responses are rated on a scale of 0 to 10, with a rating of 0 indicating 'not at all confident', a rating of 5 indicating 'moderately confident', and rating of 10 indicating t 'completely confident'. Scenarios include: "When a close friend offers you a drink," and, "When you feel depressed or nervous." Scores on this assessment are calculated by summing participant responses and dividing by the number of questions to obtain a mean self-efficacy score.
Quality of Care: Adolescent Report of the Visit (AROV)
Time frame: 1 day, immediately following baseline clinic visit
The Adolescent Report of the Visit (AROV) is a validated measure to assess the quality of care delivered to adolescents (Ozer, 2004), which has been utilized in clinics nationally and internationally (Sanci, 2015). The investigators are specifically using questions from this measure assessing provider rates of screening and counseling adolescents for alcohol use during adolescent visits. All questions are scored separately on a binary scale, with response scoring as No = 0 and Yes = 1. An answer of Yes to any item indicates higher quality of care.
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 22 Oct 2026.
- Background: PubMed 25421733Baird A, Nowak S. Why primary care practices should become digital health information hubs for their patients. BMC Fam Pract. 2014 Nov 25;15:190. doi: 10.1186/s12875-014-0190-9.
- Background: PubMed 28011064Harris SK, Aalsma MC, Weitzman ER, Garcia-Huidobro D, Wong C, Hadland SE, Santelli J, Park MJ, Ozer EM. Research on Clinical Preventive Services for Adolescents and Young Adults: Where Are We and Where Do We Need to Go? J Adolesc Health. 2017 Mar;60(3):249-260. doi: 10.1016/j.jadohealth.2016.10.005. Epub 2016 Dec 20.
- Background: PubMed 2324938Ozer EM, Bandura A. Mechanisms governing empowerment effects: a self-efficacy analysis. J Pers Soc Psychol. 1990 Mar;58(3):472-86. doi: 10.1037//0022-3514.58.3.472.
- Background: PubMed 22018561Ozer EM, Adams SH, Orrell-Valente JK, Wibbelsman CJ, Lustig JL, Millstein SG, Garber AK, Irwin CE Jr. Does delivering preventive services in primary care reduce adolescent risky behavior? J Adolesc Health. 2011 Nov;49(5):476-82. doi: 10.1016/j.jadohealth.2011.02.011. Epub 2011 Jun 8.
- Background: PubMed 26422235Sanci L, Chondros P, Sawyer S, Pirkis J, Ozer E, Hegarty K, Yang F, Grabsch B, Shiell A, Cahill H, Ambresin AE, Patterson E, Patton G. Responding to Young People's Health Risks in Primary Care: A Cluster Randomised Trial of Training Clinicians in Screening and Motivational Interviewing. PLoS One. 2015 Sep 30;10(9):e0137581. doi: 10.1371/journal.pone.0137581. eCollection 2015.
- BackgroundOzer EM, Adams SH, Lustig JL, Millstein SG, Wibbelsman CJ, Babb J. The effect of preventive services on adolescent behavior (abstract). Pediatric Research. 2004;53(suppl. 4, pt. 2):265A.
- BackgroundOzer EM. The impact of childcare responsibility and self-efficacy on the psychological health of working mothers. Psychology of Women Quarterly. 1995;19:315-35.
- BackgroundOzer E, Rowe J, Tebb K, Culbertson K, Berna M, Jasik C, et al. A self-adaptive personalized behavior change system for adolescent preventive care. The Indian Journal of Pediatrics, Special Supplement The International Association for Adolescent Health, 11th World Congress on Adolescent Health, 27-29 October, 2017, New Delhi, India2017. p. SS-1.
- Facts About Underage Drinking- National Institute on Alcohol Abuse and AlcoholismLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified data may be shared with research collaborators during the course of the study
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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.
Elizabeth Ozer, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ChangeGradients in people with Alcohol Drinking and Self Efficacy, run by University of California, San Francisco 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 1 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 22 Oct 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 Elizabeth M Ozer, PhD (415-819-6337, elizabeth.ozer@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean scores on assessment of Alcohol Use (time frame: 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04110756, which also lists 8 linked publications.
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 22 Oct 2026.