Alcohol DrinkingNCT07591428
Reset Challenge: Reducing High-risk Drinking for Cancer Prevention
A study testing 30-Day Alcohol Abstinence Challenge in people with Alcohol Drinking and Heavy Drinking, run by University of Oklahoma at 1 site in United States.
Trial summary
This is a single-arm, non-randomized, prospective study to evaluate the feasibility and preliminary efficacy of a 30-day mobile Health (mHealth) Reset Challenge for reducing high-risk drinking. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Alcohol Drinking, Heavy Drinking, Binge Drinking
- What is being tested?
- 30-Day Alcohol Abstinence Challenge
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2026to Apr 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults +18
- Individuals who drink alcohol regularly
- Further inclusion criteria will be determined via a Zoom screening with a member of the research staff.
- Current Oklahoma Resident
Who cannot join
- Exclusion criteria will be determined via a Zoom screening with a member of the research staff.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jordan Keast, BS contact
United States1 site, 1 recruiting
- Recruiting
University of Oklahoma Schusterman Center - Tulsa
Tulsa, Oklahoma, 74135
Jordan Keast, BS, jordan-keast@ou.edu
About this study
Official title: Feasibility and Preliminary Efficacy of a 30-Day Reset Challenge
This is a single-arm, non-randomized, prospective study to evaluate the feasibility and preliminary efficacy of a 30-day mobile Health (mHealth) Reset Challenge for reducing high-risk drinking.
Read the detailed description
Alcohol is a modifiable risk factor for gastrointestinal and breast cancers, with heavy, binge, and daily drinking increasing cancer risk. To reduce these cancers, accessible, effective, and scalable alcohol interventions are needed. Mobile Health (mHealth) platforms are well suited for this purpose, as they can screen for high-risk drinking and deliver on-demand, evidence-based interventions directly to at-risk individuals. Building on the success of the 'Dry January' community intervention, the current study will develop and test a 30-day Reset Challenge. This trial will recruit 150 adults with high-risk drinking behaviors in Oklahoma and pursue three aims. First, the investigators aim to evaluate the feasibility and preliminary effectiveness of the Reset Challenge. Secondly the investigators want to evaluate whether improving confidence in alcohol cessation methods is associated with a higher likelihood of achieving 30-day abstinence. The exploratory third goal is to examine the feasibility of using an alcohol sensor as an objective outcome measure in a subsample of participants. To date, "Dry January" community interventions have only minimally investigated treatment mechanisms, and their outcomes have been assessed solely through self-reported alcohol use. Findings from the current study will determine the feasibility and preliminary efficacy of the Reset Challenge and clarify the potential role of self-efficacy as a critical predictor for successful abstinence. This work will provide foundational data for future large-scale trials aimed at reducing high-risk drinking, and ultimately lowering alcohol-related cancer in the U.S.
- Conditions
- Alcohol Drinking, Heavy Drinking, Binge Drinking
- Being tested
- 30-Day Alcohol Abstinence Challenge
- Keywords
- Daily drinking, Binge or Heavy Drinking, Dry January, Abstinence Challenge, 30-day break
- Medical subject headings
- Alcohol Drinking, Binge Drinking, Binge-Eating Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
30-Day Alcohol Abstinence ChallengeBehavioural
The 30-Day reset challenge is inspired by community intervention tools like 'Dry January'. Throughout the month long trial period, participants will be asked to abstain from alcohol consumption entirely.
| Study group | Role | What they receive |
|---|---|---|
| 30-Day Reset | Experimental | Participants will take part in a 30-day alcohol abstinence challenge. For 2 weeks before, and during the challenge participants will fill out daily surveys monitoring alcohol consumption. Additionally, there will be a longer 1 and 3-month follow-up survey after the completion of the challenge. Receives: Behavioral: 30-Day Alcohol Abstinence Challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of intervention based on rate of accrual with eligible participant population
Rate of study participation among eligible population that completes the screening survey. ≥50% of eligible individuals will enroll in the study
Measured: From completion of the pre-screening survey to enrollment in the study. On average, no more than two weeks.
Feasibility of intervention based on rate of completion amongst enrolled participants
Rate of completion among enrolled participants. ≥80% of enrolled participants will complete the study
Measured: From enrollment to 3 months after the completion of the 30-Day Reset Challenge. On average, about four months, depending on the participant's selected start date.
Feasibility of intervention based on efficient accrual
Amount of participants recruited to the study in a 12 month period. A total of 150 participants will be recruited within 12 months
Measured: From the opening of the studies accrual to 12 months later.
Efficacy of intervention based on reported alcohol abstinence
Percentage of patients that report abstaining from alcohol throughout the duration of the study. ≥ 60% of participants will abstain from alcohol during the challenge
Measured: From 2 weeks before the participant selected challenge start date to the end of the 30-day reset challenge. Exactly 44 days.
Efficacy of intervention based on the weekly alcohol consumption of participants
The average rate of weekly alcohol consumption reported by participants throughout the duration of the study. Rates of alcohol consumption are expected to be maintained or decrease weekly.
Measured: From the time the participant completes the baseline survey to the completion of the 30-day challenge period. On average, about two months, depending on the participant's selected start date.
Secondary outcomes (4)
Efficacy of intervention base on alcohol abstinence self-efficacy
Self-reported confidence in the ability to abstain from alcohol, assessed using a daily rating scale (e.g., 0-10). Abstinence self-efficacy is expected to be maintained or increase over the duration of the study.
Measured: From the beginning of the 30-day challenge period to the end of the 30-day challenge period. Exactly 30 days.
Efficacy of intervention based on reported alcohol use
Rate of self-reported alcohol consumption (weekly quantity) in daily survey. It is expected that rates of consumption will be maintained or decrease throughout the challenge period.
Measured: From the beginning of the 30-day challenge period to the end of the 30-day challenge period. Exactly 30 days.
Efficacy of intervention based on sustained abstinence
Rate of self-reported alcohol use (weekly quantity) after completion of 30 day challenge period. It is expected that rates will be maintained or continue to decrease after the 30 day challenge period
Measured: From completion of the 30-day challenge period to 3 months post-completion of the 30-day challenge period. Exactly 3 months.
Efficacy of intervention based on sustained alcohol abstinence self-efficacy
Reported score of alcohol abstinence self-efficacy given on survey scale (e.g., 1-10) after the challenge period. It is expected that self-efficacy scoring will be maintained or increase after complete of the 30 day challenge period.
Measured: From the completion of the baseline survey to 3 months after the completion of the 30-day challenge period. On average, about 4 months, depending on the participant's selected start date.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start10 Jun 2026
- Primary completionDec 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- Presbyterian Health Foundation
- Responsible party
- Sponsor
- Investigators
- Sophia You, PhD, ABPP, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07591428
- Sponsor's protocol ID
- 19340P
- Status last verified
- Jun 2026
- First submitted
- 28 Apr 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Preliminary Efficacy of a 30-Day Reset Challenge
- ClinicalTrials.gov ID
- NCT07591428
- Acronym / sponsor ID
- 19340P
- Conditions
- Alcohol Drinking, Heavy Drinking, Binge Drinking
- Keywords
- Daily drinking, Binge or Heavy Drinking, Dry January, Abstinence Challenge, 30-day break
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- Presbyterian Health Foundation
- Study start
- 10 Jun 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 15 May 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 is a single-arm, non-randomized, prospective study to evaluate the feasibility and preliminary efficacy of a 30-day mobile Health (mHealth) Reset Challenge for reducing high-risk drinking.
Detailed description
Alcohol is a modifiable risk factor for gastrointestinal and breast cancers, with heavy, binge, and daily drinking increasing cancer risk. To reduce these cancers, accessible, effective, and scalable alcohol interventions are needed. Mobile Health (mHealth) platforms are well suited for this purpose, as they can screen for high-risk drinking and deliver on-demand, evidence-based interventions directly to at-risk individuals. Building on the success of the 'Dry January' community intervention, the current study will develop and test a 30-day Reset Challenge. This trial will recruit 150 adults with high-risk drinking behaviors in Oklahoma and pursue three aims. First, the investigators aim to evaluate the feasibility and preliminary effectiveness of the Reset Challenge. Secondly the investigators want to evaluate whether improving confidence in alcohol cessation methods is associated with a higher likelihood of achieving 30-day abstinence. The exploratory third goal is to examine the feasibility of using an alcohol sensor as an objective outcome measure in a subsample of participants. To date, "Dry January" community interventions have only minimally investigated treatment mechanisms, and their outcomes have been assessed solely through self-reported alcohol use. Findings from the current study will determine the feasibility and preliminary efficacy of the Reset Challenge and clarify the potential role of self-efficacy as a critical predictor for successful abstinence. This work will provide foundational data for future large-scale trials aimed at reducing high-risk drinking, and ultimately lowering alcohol-related cancer in the U.S.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 30-Day Reset | Experimental | Behavioral: 30-Day Alcohol Abstinence ChallengeParticipants will take part in a 30-day alcohol abstinence challenge. For 2 weeks before, and during the challenge participants will fill out daily surveys monitoring alcohol consumption. Additionally, there will be a longer 1 and 3-month follow-up survey after the completion of the challenge. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults +18
- Individuals who drink alcohol regularly
- Further inclusion criteria will be determined via a Zoom screening with a member of the research staff.
- Current Oklahoma Resident
Key exclusion criteria (1 listed)
- Exclusion criteria will be determined via a Zoom screening with a member of the research staff.
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 |
|---|---|---|
| 30-Day Alcohol Abstinence ChallengeThe 30-Day reset challenge is inspired by community intervention tools like 'Dry January'. Throughout the month long trial period, participants will be asked to abstain from alcohol consumption entirely. | Behavioural | 30-Day Reset |
Primary outcome
Feasibility of intervention based on rate of accrual with eligible participant population
Time frame: From completion of the pre-screening survey to enrollment in the study. On average, no more than two weeks.
Rate of study participation among eligible population that completes the screening survey. ≥50% of eligible individuals will enroll in the study
Feasibility of intervention based on rate of completion amongst enrolled participants
Time frame: From enrollment to 3 months after the completion of the 30-Day Reset Challenge. On average, about four months, depending on the participant's selected start date.
Rate of completion among enrolled participants. ≥80% of enrolled participants will complete the study
Feasibility of intervention based on efficient accrual
Time frame: From the opening of the studies accrual to 12 months later.
Amount of participants recruited to the study in a 12 month period. A total of 150 participants will be recruited within 12 months
Efficacy of intervention based on reported alcohol abstinence
Time frame: From 2 weeks before the participant selected challenge start date to the end of the 30-day reset challenge. Exactly 44 days.
Percentage of patients that report abstaining from alcohol throughout the duration of the study. ≥ 60% of participants will abstain from alcohol during the challenge
Efficacy of intervention based on the weekly alcohol consumption of participants
Time frame: From the time the participant completes the baseline survey to the completion of the 30-day challenge period. On average, about two months, depending on the participant's selected start date.
The average rate of weekly alcohol consumption reported by participants throughout the duration of the study. Rates of alcohol consumption are expected to be maintained or decrease weekly.
4 secondary outcomes
Efficacy of intervention base on alcohol abstinence self-efficacy
Time frame: From the beginning of the 30-day challenge period to the end of the 30-day challenge period. Exactly 30 days.
Efficacy of intervention based on reported alcohol use
Time frame: From the beginning of the 30-day challenge period to the end of the 30-day challenge period. Exactly 30 days.
Efficacy of intervention based on sustained abstinence
Time frame: From completion of the 30-day challenge period to 3 months post-completion of the 30-day challenge period. Exactly 3 months.
Efficacy of intervention based on sustained alcohol abstinence self-efficacy
Time frame: From the completion of the baseline survey to 3 months after the completion of the 30-day challenge period. On average, about 4 months, depending on the participant's selected start date.
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 26 Jun 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.
Jordan Keast, BS contact
Sophia You, PhD, ABPP principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 30-Day Alcohol Abstinence Challenge in people with Alcohol Drinking and Heavy Drinking, run by University of Oklahoma 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 4 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 26 Jun 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 Sophia You, PhD, ABPP (918-660-3923, Dokyoung-You@ou.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of intervention based on rate of accrual with eligible participant population (time frame: From completion of the pre-screening survey to enrollment in the study. On average, no more than two weeks.). The study lists 5 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 26 Jun 2026.