Study of a Smartphone-Based Alcohol Reduction Program

NCT ID: NCT06401967

Last Updated: 2024-07-01

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-30
• Study Completion Date: 2026-06-30

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).

Conditions

Alcohol Use, Unspecified

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Pivot Clear

A program for alcohol reduction

Group Type: EXPERIMENTAL

Pivot Clear

Intervention Type: BEHAVIORAL

A mobile app and program for alcohol reduction.

BACtrack breathalyzer

Intervention Type: DEVICE

Personal breathalyzer device that measures blood alcohol content.

Interventions

Pivot Clear

A mobile app and program for alcohol reduction.

Intervention Type: BEHAVIORAL

BACtrack breathalyzer

Personal breathalyzer device that measures blood alcohol content.

Intervention Type: DEVICE

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.)

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pivot Health Technologies Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Jennifer Marler, MD

VP of Clinical and Medical Affairs

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennifer Marler, MD

Role: PRINCIPAL_INVESTIGATOR

Pivot Health Technologies Inc.

Locations

Pivot Health Technologies, Inc.

San Carlos, California, United States

Countries

United States

Other Identifiers

C-510

Identifier Type: -

Identifier Source: org_study_id