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The Less is More Study

Primary Purpose

Alcohol Use

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Counseling
mHealth
Counseling
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcohol Use

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Report heavy drinking (i.e., 5 or more drinks in a day for men, 4 or more drinks in a day for women) at least twice or report any 7 day period at hazardous drinking levels (greater than 14 drinks for men, greater than 7 drinks for women) 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:

  • Axis I psychiatric disorders including substance use disorder other than mild or moderate alcohol or mild cannabis use disorder
  • 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
  • Self-reported consumption of over 300 drinks in the past 30 days on the TLFB Contact PD/PI: Cook, Robert L Project-001 (000) Data and Safety Monitoring Plan Page 455
  • 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.
  • Positive urine screen indicating recent opioid use
  • 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
  • Diagnosed major psychiatric disorder
  • Pregnancy
  • Opioid use
  • Recent inpatient or intensive treatment for addictive behaviors

Sites / Locations

  • University of MiamiRecruiting
  • University of FloridaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Non-Contingent Condition

mHealth and CM

CM

Arm Description

Participants will wear a wrist biosensor with daily CM based on smartphone breathalyzer readings for 30 days; then for a second 30 days, encouragement to reduce drinking but payment not based on drinking.

Participants will wear a wrist biosensor with daily CM based on smartphone breathalyzer readings for 30 days; then for a second 30 days, weekly CM based on wrist biosensor readings. Participants will also interact with a mobile health application to facilitate drinking reduction.

Participants will wear a wrist biosensor with daily CM based on smartphone breathalyzer readings for 30 days; then for a second 30 days, weekly CM based on wrist biosensor readings

Outcomes

Primary Outcome Measures

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
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.
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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
December 2, 2021
Last Updated
June 5, 2023
Sponsor
University of Florida
Collaborators
University of Miami, University of Louisville, Florida State University, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT05153811
Brief Title
The Less is More Study
Official Title
Novel Extensions of Alcohol Contingency Management in People Living With HIV
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 10, 2022 (Actual)
Primary Completion Date
September 1, 2026 (Anticipated)
Study Completion Date
September 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
University of Miami, University of Louisville, Florida State University, National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Non-Contingent Condition
Arm Type
Experimental
Arm Description
Participants will wear a wrist biosensor with daily CM based on smartphone breathalyzer readings for 30 days; then for a second 30 days, encouragement to reduce drinking but payment not based on drinking.
Arm Title
mHealth and CM
Arm Type
Experimental
Arm Description
Participants will wear a wrist biosensor with daily CM based on smartphone breathalyzer readings for 30 days; then for a second 30 days, weekly CM based on wrist biosensor readings. Participants will also interact with a mobile health application to facilitate drinking reduction.
Arm Title
CM
Arm Type
Experimental
Arm Description
Participants will wear a wrist biosensor with daily CM based on smartphone breathalyzer readings for 30 days; then for a second 30 days, weekly CM based on wrist biosensor readings
Intervention Type
Behavioral
Intervention Name(s)
Counseling
Intervention Description
Brief counseling including personalized feedback on breath alcohol concentration, cognitive task performance and physical functioning
Intervention Type
Behavioral
Intervention Name(s)
mHealth
Intervention Description
Participants will engage with an application designed to gamify drinking reduction.
Intervention Type
Behavioral
Intervention Name(s)
Counseling
Intervention Description
Brief counseling including personalized feedback on breath alcohol concentration, cognitive task performance and physical functioning.
Primary Outcome Measure Information:
Title
Percent days abstinent via smartphone breathalyzer readings
Description
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
Time Frame
Baseline to 30 Days
Title
Predict percent days abstinent via smartphone breathalyzer readings based on risk factors.
Description
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.
Time Frame
Baseline to 30 Days
Title
Perceived value and ease of use of novel contingency management strategies to reduce alcohol consumption.
Description
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.
Time Frame
30 Days to 60 Days
Title
Drinking reduction through Contingency Management will predict non-drinking outcomes
Description
Participants who are able to successfully reduce their alcohol consumption may see other health benefits including reduced HIV viral load.
Time Frame
Baseline to 90 days
Secondary Outcome Measure Information:
Title
Percent days abstinent via wrist biosensor readings
Description
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.
Time Frame
Baseline to 60 Days
Other Pre-specified Outcome Measures:
Title
Percent days abstinent via self-report
Description
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.
Time Frame
Baseline to 180 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emmely Pavila
Phone
352-273-9562
Email
empavila17@ufl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Leeman, Ph.D
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Varan Govind, PhD
Phone
305-243-8096
Email
vgovind@med.miami.edu
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmely Pavila, B.A., B.S.
Phone
352-273-9562
Email
empavila17@ufl.edu
First Name & Middle Initial & Last Name & Degree
Yan Wang, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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The Less is More Study

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