Study of a Smartphone-Based Alcohol Reduction Program

Feasibility, Acceptability, and Preliminary Outcomes of a Smartphone-Based Program for Reduction in Alcohol Consumption

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.

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).

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.)