Alcohol UseNCT05153811
The Less is More Study
A study testing Counseling and mHealth in people with Alcohol Use, run by University of Florida at 2 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Alcohol Use
- What is being tested?
- Counseling and mHealth
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Jun 2022to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of Miami
Coral Gables, Florida, 33146
Varan Govind, PhD, 305-243-8096, vgovind@med.miami.edu
- Recruiting
University of Florida
Gainesville, Florida, 32610
Emmely Pavila, B.A., B.S., 352-273-9562, empavila17@ufl.edu
Yan Wang, PhD
About this study
Official title: Novel Extensions of Alcohol Contingency Management in People Living With HIV
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.
- Conditions
- Alcohol Use
- Being tested
- Counseling, mHealth
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CounselingBehavioural
Brief counseling including personalized feedback on breath alcohol concentration, cognitive task performance and physical functioning
mHealthBehavioural
Participants will engage with an application designed to gamify drinking reduction.
CounselingBehavioural
Brief counseling including personalized feedback on breath alcohol concentration, cognitive task performance and physical functioning.
| Study group | Role | What they receive |
|---|---|---|
| Non-Contingent Condition | Experimental | 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. Receives: Behavioral: Counseling |
| mHealth and CM | Experimental | 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. Receives: Behavioral: Counseling; Behavioral: mHealth |
| CM | Experimental | 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 Receives: Behavioral: Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline to 30 Days
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.
Measured: Baseline to 30 Days
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.
Measured: 30 Days to 60 Days
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.
Measured: Baseline to 90 days
Secondary outcomes (1)
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.
Measured: Baseline to 60 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2021
- Study start10 Jun 2022
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol UseStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- University of Miami, University of Louisville, Florida State University, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Robert Leeman, Ph.D, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05153811
- Sponsor's protocol ID
- CED000000577
- Other IDs
- P01AA029543, PRO00035889, OCR41499, CED000000577
- Status last verified
- Jul 2025
- First submitted
- 2 Dec 2021
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Extensions of Alcohol Contingency Management in People Living With HIV
- ClinicalTrials.gov ID
- NCT05153811
- Acronym / sponsor ID
- CED000000577
- Conditions
- Alcohol Use
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- University of Miami, University of Louisville, Florida State University, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 10 Jun 2022 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 10 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non-Contingent Condition | Experimental | Behavioral: CounselingParticipants 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. |
| mHealth and CM | Experimental | Behavioral: Counseling, Behavioral: mHealthParticipants 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. |
| CM | Experimental | Behavioral: CounselingParticipants 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 |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CounselingBrief counseling including personalized feedback on breath alcohol concentration, cognitive task performance and physical functioning | Behavioural | CM, mHealth and CM |
| mHealthParticipants will engage with an application designed to gamify drinking reduction. | Behavioural | mHealth and CM |
| CounselingBrief counseling including personalized feedback on breath alcohol concentration, cognitive task performance and physical functioning. | Behavioural | Non-Contingent Condition |
Primary outcome
Percent days abstinent via smartphone breathalyzer readings
Time frame: Baseline to 30 Days
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.
Time frame: Baseline to 30 Days
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.
Time frame: 30 Days to 60 Days
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
Time frame: Baseline to 90 days
Participants who are able to successfully reduce their alcohol consumption may see other health benefits including reduced HIV viral load.
1 secondary outcome
Percent days abstinent via wrist biosensor readings
Time frame: Baseline to 60 Days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Alcohol Use
RecruitingPhase 1
Environment and Alcohol: A Pilot Study
Alcohol Use Disorder
RecruitingObservational study
SMART-r: Substance Monitoring and Active Relapse Tracking Repository
Alcoholism, Substance-Related Disorders
Recruiting
Evaluating Caregiver Involvement in Primary Care-Based Brief Interventions for Adolescent Alcohol Use Problems
Alcohol Use, Adolescent
Recruiting
Peer Support for Liver Transplant Recipients With History of ALD
Alcohol Use Disorder, Alcohol Related Liver Disease
Recruiting
Safety and Effectiveness of the BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMS) for Treatment and Reduction of Heavy Drinking in Individuals With of Alcohol Use Disorder (AUD)
Alcohol Use Disorder, Alcoholism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert Leeman, Ph.D principal investigator
University of Florida
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Counseling and mHealth in people with Alcohol Use, run by University of Florida at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emmely Pavila (352-273-9562, empavila17@ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent days abstinent via smartphone breathalyzer readings (time frame: Baseline to 30 Days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.