NCT06401967

Study of a Smartphone-Based Alcohol Reduction Program

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Pivot Health Technologies Inc. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

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).

Conditions

• Alcohol Use, Unspecified

Interventions

Type	Name	Description
BEHAVIORAL	Pivot Clear	A mobile app and program for alcohol reduction.
DEVICE	BACtrack breathalyzer	Personal breathalyzer device that measures blood alcohol content.

Timeline

• Start date: 2024-06-01
• Primary completion: 2025-06-01
• Completion: 2026-06-01
• First posted: 2024-05-07
• Last updated: 2024-07-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study