Health TrialsbyHealthPanel

The Less is More Study

ConditionAlcohol Use
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-70
SponsorUniversity of Florida

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Counseling

    Behavioral

    Brief counseling including personalized feedback on breath alcohol concentration, cognitive task performance and physical functioning

  • mHealth

    Behavioral

    Participants will engage with an application designed to gamify drinking reduction.

  • Counseling

    Behavioral

    Brief counseling including personalized feedback on breath alcohol concentration, cognitive task performance and physical functioning.

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: Non-Contingent ConditionExperimental treatment 1 intervention
Group B: mHealth and CMExperimental treatment 2 interventions
Group C: CMExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Baseline to 30 Days
2

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.

Time frame
Baseline to 30 Days
3

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.

Time frame
30 Days to 60 Days
4

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.

Time frame
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.

Time frame
Baseline to 60 Days

Other outcomes

1

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.

Time frame
Baseline to 180 Days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Florida

Lead sponsor

University of Miami

Collaborator

University of Louisville

Collaborator

Florida State University

Collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Source ClinicalTrials.gov
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