Clinical trial NCT06401967: Study of a Smartphone-Based Alcohol Reduction Program
Official title: Feasibility, Acceptability, and Preliminary Outcomes of a Smartphone-Based Program for Reduction in Alcohol Consumption
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Alcohol Use, Unspecified
Keywords: alcohol reduction
digital health
mobile apps
health promotion
Lead sponsor: Pivot Health Technologies Inc.
Sponsor class: INDUSTRY
First posted: 2024-05-07
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Prospective, open label, single center clinical study enrolling up to 100 adult participants to evaluate the feasibility, acceptability, and preliminary outcomes of the Pivot Clear smartphone-based alcohol reduction program.

Detailed description: This is a prospective, open label, single center clinical study conducted with institutional review board (IRB) approval enrolling up to 100 adult participants who report at-risk alcohol consumption behavior and would like to reduce or eliminate alcohol consumption. The study will be performed remotely on an ambulatory basis. Participants will be asked to set up and use the Pivot Clear program. The program includes an app, personal breathalyzer, and short message service (SMS) text-based coaching with an alcohol reduction specialist. The study duration is 52 weeks. While participants will have access to the program for 52 weeks, it is expected that for most participants, most active participation in the program will be complete by 12 weeks. The primary reporting time point will be 12 weeks, with expected passive, longer-term follow-up outcomes collected at 26 weeks and 52 weeks. Participants will receive online questionnaires at intervals throughout the study (baseline, weekly for the first 12 weeks, at 26 weeks and at 52 weeks).

Eligibility criteria: Inclusion Criteria:

* Score of ≥ 3 for women and ≥ 4 for men on the AUDIT-C at screening
* Would like to reduce or eliminate alcohol consumption
* Resident of the United States
* Able to read and comprehend English
* Owns and uses a smartphone compatible with the study app (iPhone 6 and above, operating system iOS (iPhone operating system) 15 and above, or Android 7.0 and above, operating system Android 7.0 and above)
* Has daily internet access on smartphone
* Comfortable downloading and using smartphone apps
* Interested in working with an alcohol reduction coach via SMS text
* Willing to sign the Informed Consent Form (ICF)

Exclusion Criteria:

* Currently using other support to reduce or quit alcohol, including apps, coaching, support groups, classes or quit programs
* Pregnant (self-reported)
* Self-reported past or present diagnosis of Alcohol Use Disorder (AUD)
* Self-reported past or present diagnosis of Substance Use Disorder
* Current use of the following medications: suboxone, methadone, or daily use of a benzodiazepine \[including Alprazolam (e.g., Xanax), lorazepam (e.g., Ativan), clonazepam (e.g., Klonopin), diazepam (e.g., Valium), and temazepam (e.g., Restoril)\]
* History of hospitalization or in-patient treatment due to alcohol use
* Using other alcohol reduction or abstinence apps, coaching, support groups, classes, or programs at study entry
* Failure to provide contact or collateral information, and/or failure to verify email address
* Participation in a previous study sponsored by Pivot Health Technologies, Inc. (formerly Carrot Inc.)

Primary outcomes:
measure: Proportion of participants who complete all 12 weekly follow-up assessments
timeFrame: 12 weeks
Secondary outcomes:
measure: Trial feasibility - enrollment
timeFrame: Baseline
measure: Trial feasibility - questionnaire completion
timeFrame: 52 weeks
measure: Average weekly alcohol consumption
timeFrame: 1-12, 26, and 52 weeks
measure: Proportion of participants with average drinks per day ≤ 2/day for men and ≤ 1/day for women
timeFrame: 1-12, 26, and 52 weeks
measure: Proportion of participants who complied with the low-risk guideline for problematic drinking
timeFrame: 1-12, 26, and 52 weeks
measure: Average daily alcohol consumption
timeFrame: 1-12, 26, and 52 weeks
measure: Average drinks per drinking day
timeFrame: 1-12, 26, and 52 weeks
measure: Proportion of participants with an AUDIT-C score below the threshold for unhealthy alcohol use in the U.S.
timeFrame: 12, 26, and 52 weeks
measure: Proportion of participants who reduced their AUDIT-C score category by by ≥ 1 risk level
timeFrame: 12, 26, and 52 weeks
measure: Proportion of participants with an AUDIT score within the "lower risk" category
timeFrame: 12, 26, and 52 weeks
measure: Proportion of participants who reduced their AUDIT score category by by ≥ 1 risk level
timeFrame: 12, 26, and 52 weeks
measure: Number of heavy drinking days
timeFrame: 1-12, 26, and 52 weeks
measure: Maximum number of drinks on any day over the timeline follow-back period
timeFrame: 1-12, 26, and 52 weeks
measure: Proportion of days abstinent
timeFrame: 1-12, 26, and 52 weeks
measure: Average duration of continuous abstinence
timeFrame: 12, 26, and 52 weeks
measure: Proportion of participants who reduced their World Health Organization (WHO) risk drinking level by ≥ 1 risk level
timeFrame: 12, 26, and 52 weeks
measure: Adverse consequence related to alcohol
timeFrame: 12, 26, and 52 weeks
measure: Drinking motivations
timeFrame: 12, 26, and 52 weeks
measure: Desire to change drinking habits
timeFrame: Baseline
measure: Reasons for desired change in drinking habits
timeFrame: Baseline
measure: Readiness to change
timeFrame: 4 and 12 weeks
measure: Expected success to change drinking habits
timeFrame: 4 and 12 weeks
measure: Expected difficulty maintaining reduction/abstinence
timeFrame: 4 and 12 weeks
measure: Satisfaction with current drinking behavior
timeFrame: 12, 26, and 52 weeks
measure: User feedback - set up and getting started with the program
timeFrame: 4 weeks
measure: User satisfaction - Net Promoter Score
timeFrame: 4, 12, and 26 weeks
measure: User satisfaction - how use of the program has affected alcohol consumption
timeFrame: 5 weeks
measure: User satisfaction - effectiveness of the program
timeFrame: 12 weeks
measure: User satisfaction - whether the program helped the participant maintain alcohol reduction
timeFrame: 12, 26, and 52 weeks
measure: User satisfaction - program's ability to help someone reduce or quit alcohol
timeFrame: 10 weeks
measure: User satisfaction - perceived need for the program
timeFrame: 4 weeks
measure: User satisfaction - effect of program on motivation to reduce/abstain
timeFrame: 3 weeks
measure: User feedback - initial reactions to program design, specific program features including the breathalyzer, coaching, lessons, and drink tracking
timeFrame: 1 week
measure: User feedback - program design, specific program features including the breathalyzer, coaching, lessons, and drink tracking
timeFrame: 2, 3, 5, and 12 weeks
measure: User satisfaction - aspects of program participant enjoyed most/least
timeFrame: 12 weeks
measure: User feedback - possible future program features
timeFrame: 12 weeks
measure: Use of other alcohol reduction or abstinence tools (apps, counseling, medications, etc.)
timeFrame: 11, 26, and 52 weeks
measure: Engagement with the program - app openings
timeFrame: 26 weeks
measure: Engagement with program - number of days with app openings
timeFrame: 26 weeks
measure: Engagement with program - number of weeks with app openings
timeFrame: 26 weeks
measure: Engagement with program - average duration of app sessions
timeFrame: 26 weeks
measure: Engagement with program - use of app features
timeFrame: 26 weeks
measure: Engagement with program - average number of messages
timeFrame: 26 weeks
measure: Engagement with program - average number of weeks with coach engagement
timeFrame: 26 weeks
measure: Change in ratings of self-reported health indicators
timeFrame: 12 and 26 weeks
measure: Average rating of positive change experienced in self-reported health indicators
timeFrame: 12 and 26 weeks
measure: Depressive symptoms
timeFrame: 12, 26, and 52 weeks
measure: Anxiety
timeFrame: 12, 26, and 52 weeks
measure: Resilience
timeFrame: 12, 26, and 52 weeks
measure: Well-being
timeFrame: 12, 26, and 52 weeks
Other outcomes:
Locations:
city: San Carlos
country: United States
facility: Pivot Health Technologies, Inc.
state: California
Study officials:
affiliation: Pivot Health Technologies Inc.
name: Jennifer Marler, MD
role: PRINCIPAL_INVESTIGATOR
References: