Study of a Smartphone-Based Alcohol Reduction Program

NCT06401967 | Withdrawn FDA Device

• 1 other identifier: C-510
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Use, Unspecified

Keywords

alcohol reduction; digital health; mobile apps; health promotion

Outcome Measures

Primary Outcomes (1)

• Proportion of participants who complete all 12 weekly follow-up assessments

  Calculated as the number of participants who complete 12/12 of the weekly follow-up assessments (specifically during the first 12 weeks of the study), divided by the total number of enrolled participants.

  12 weeks

Secondary Outcomes (50)

• Trial feasibility - enrollment

  Baseline

• Trial feasibility - questionnaire completion

  52 weeks

• Average weekly alcohol consumption

  1-12, 26, and 52 weeks

• Proportion of participants with average drinks per day ≤ 2/day for men and ≤ 1/day for women

  1-12, 26, and 52 weeks

• Proportion of participants who complied with the low-risk guideline for problematic drinking

  1-12, 26, and 52 weeks

Study Arms (1)

Pivot Clear

EXPERIMENTAL

A program for alcohol reduction

Behavioral: Pivot Clear; Device: BACtrack breathalyzer

Interventions

Pivot Clear BEHAVIORAL

A mobile app and program for alcohol reduction.

Pivot Clear

BACtrack breathalyzer DEVICE

Personal breathalyzer device that measures blood alcohol content.

Pivot Clear

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Pivot Health Technologies Inc.: lead

Study Sites (1)

Pivot Health Technologies, Inc.

San Carlos, California, 94070, United States

Location

MeSH Terms

Conditions

Alcohol Drinking

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Study Officials

• Jennifer Marler, MD

  Pivot Health Technologies Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: VP of Clinical and Medical Affairs

Study Record Dates

• First Submitted: May 2, 2024
• First Posted: May 7, 2024
• Study Start: June 1, 2024
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 1, 2024

Record last verified: 2024-06

Locations

US (1)