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Search / Trial NCT05153811

The Less is More Study

Launched by UNIVERSITY OF FLORIDA · Dec 9, 2021

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

The Less is More Study is a clinical trial aimed at helping individuals living with HIV reduce their alcohol use. The study will use innovative tools, like a smartphone breathalyzer and a wrist-worn device that tracks alcohol consumption, to support participants in their journey to cut back on drinking. Participants will take part in a program using these mobile health tools for 30 to 60 days, with follow-ups lasting up to six months to check on their progress.

To join the study, you must be HIV positive and have regularly consumed alcohol in the past month. You should also be comfortable using smartphone apps and devices, and be willing to try abstaining from alcohol for at least 30 days. If you don't have a compatible smartphone, the study will provide one for you. However, individuals with certain psychiatric conditions, those currently going through alcohol withdrawal, or those who have recently undergone intensive treatment for addiction will not be eligible. This study offers a supportive environment to help you make positive changes in your alcohol use with the help of modern technology.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Frequent alcohol use in the past 30 days based on responses on the Timeline Followback (TLFB; Sobell and Sobell, 2003)
  • HIV positive
  • Fluency in English
  • Willingness to attempt alcohol abstinence for at least 30 days and then to attempt alcohol use on fewer days than at baseline after that
  • Willingness to use smartphone applications and biosensor devices (i.e., breathalyzer device and wrist sensor) for alcohol use reduction purposes in the study. If participants do not have a compatible smartphone to use, they will be loaned one by the study
  • Exclusion Criteria:
  • Psychiatric conditions that would interfere with participation in the study
  • Current alcohol withdrawal as indicated by a score of 8 or higher on the Clinical Institute Withdrawal Scale (CIWA; Sullivan et al., 1989) or lifetime history of medically assisted detoxification
  • Two positive breath alcohol concentration (BrAC) readings (i.e., \> 0.00%) at an in-person screening appointment. After participants blow their first positive BrAC, they will be allowed to reschedule and participate at another time, however if they blow a second positive BrAC, they will be excluded from this study and offered referrals for alcohol treatment.
  • Currently seeking or past-12-month history of inpatient or intensive treatment for addictive behaviors
  • Psychosis or other severe psychiatric disability
  • Pregnancy, nursing or lack of reliable birth control use for women who have not yet reached menopause

About University Of Florida

The University of Florida, a leading research institution, is dedicated to advancing healthcare through innovative clinical trials. With a focus on enhancing patient outcomes and exploring new therapeutic avenues, the university leverages its extensive resources, interdisciplinary expertise, and state-of-the-art facilities to conduct rigorous research across a variety of medical fields. Committed to ethical standards and patient safety, the University of Florida fosters collaboration among researchers, healthcare professionals, and community stakeholders to translate scientific discoveries into impactful clinical applications.

Locations

Gainesville, Florida, United States

Gainesville, Florida, United States

Coral Gables, Florida, United States

Gainesville, Florida, United States

Patients applied

0 patients applied

Trial Officials

Robert Leeman, Ph.D

Principal Investigator

University of Florida

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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