An interventional study of 30-Day Alcohol Abstinence Challenge in Alcohol Drinking, Heavy Drinking and Binge Drinking, sponsored by University of Oklahoma. Recruiting at 1 site in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2026-06-26.
Sponsored by University of Oklahoma · Not applicable, Interventional, and Treatment
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.
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.
71 studies on the registry are indexed under Binge Drinking; 20 are open to participants now.
This study's planned enrollment of 150 is above the median of 120 across 64 interventional studies indexed under Binge Drinking.
Browse Binge Drinking studies →University of Oklahoma is the lead sponsor of 432 studies on the registry; 100 are open to participants now.
Of its 42 completed or terminated interventional studies of FDA-regulated products, 16 (38%) have results posted.
Compared within Binge Drinking, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Alcohol Drinking. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
- Exclusion criteria will be determined via a Zoom screening with a member of the research staff.
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.
Behavioral: 30-Day Alcohol Abstinence Challenge
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.
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
Time frame: 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
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.
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
Time frame: 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
Time frame: 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.
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.
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.
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
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.
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
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
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
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.
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.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Started Jun 2026 (actual). Primary completion is estimated for Dec 2027, 18 months after the start.
Of 38 interventional studies with no phase under Binge Drinking, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 49. This study's planned 18 months is below that.
How these figures are worked out, and which studies are left out of them.
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