The Less is More Study

Alcohol Use Clinical Trial

Official title:

Novel Extensions of Alcohol Contingency Management in People Living With HIV

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05153811
• Other study ID #: CED000000577
• Secondary ID: P01AA029543PRO00
• Status: Recruiting
• Phase: N/A
• Start date: June 10, 2022
• Est. completion date: September 1, 2026

Study information

• Verified date: June 2023
• Source: University of Florida
• Contact: Emmely Pavila
• Phone: 352-273-9562
• Email: empavila17[@]ufl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this project, the investigators will implement innovations to extend use of Contingency Management (CM) to facilitate alcohol use reduction among people living with HIV (PLWH). The investigators' approach to extending CM will use mobile health (mHealth) tools including a smartphone breathalyzer device with accompanying app and a wrist worn alcohol biosensor. Participants will be engaged in mobile facilitated CM for 30-60 days with follow-up out to 6 months.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 1, 2026
• Est. primary completion date: September 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use

Intervention

Behavioral:
• Counseling
Brief counseling including personalized feedback on breath alcohol concentration, cognitive task performance and physical functioning
• mHealth
Participants will engage with an application designed to gamify drinking reduction.
• Counseling
Brief counseling including personalized feedback on breath alcohol concentration, cognitive task performance and physical functioning.

Locations

Country	Name	City	State
United States	University of Miami	Coral Gables	Florida
United States	University of Florida	Gainesville	Florida

Sponsors (5)

Lead Sponsor	Collaborator
University of Florida	Florida State University, National Institute on Alcohol Abuse and Alcoholism (NIAAA), University of Louisville, University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percent days abstinent via self-report	Among responders during the Phase 1 Contingency Management induction period, comparison among Phase 2 study conditions regarding percent abstinent days during the post-intervention, follow-up period based on self-report assessed with the timeline followback from days 61-180. Percent days abstinent at baseline based on self-report and based on smartphone breathalyzer readings during Phase 1 and based on wrist biosensor readings during Phase 2 will be included in this model.	Baseline to 180 Days
Primary	Percent days abstinent via smartphone breathalyzer readings	Within-subject comparison between percent abstinent days based on smartphone breathalyzer readings during the 30-Day Phase 1 Contingency Management induction compared to the 30-day baseline period based on self-report on the timeline followback	Baseline to 30 Days
Primary	Predict percent days abstinent via smartphone breathalyzer readings based on risk factors.	All participants will attempt to reduce alcohol consumption. Only those who are able to will continue to the second phase of the intervention. We will seek to identify which factors are predictive of abstinence.	Baseline to 30 Days
Primary	Perceived value and ease of use of novel contingency management strategies to reduce alcohol consumption.	Participants will engage in a Contingency Management program aimed at reducing alcohol consumption. A novel CM delivery system will be used intended to gamify the process.	30 Days to 60 Days
Primary	Drinking reduction through Contingency Management will predict non-drinking outcomes	Participants who are able to successfully reduce their alcohol consumption may see other health benefits including reduced HIV viral load.	Baseline to 90 days
Secondary	Percent days abstinent via wrist biosensor readings	Among responders during the Phase 1 Contingency Management induction period, comparison among Phase 2 study conditions regarding percent abstinent days based on wrist biosensor readings. Percent days abstinent at baseline based on self-report and based on smartphone breathalyzer readings during Phase 1 will be included in this model.	Baseline to 60 Days