30-to-90 Day Challenge: Effects of Alcohol Cessation on Health Outcomes

Summary

The objective for this project is to determine whether how certain behavioral and health functions change in persons with heavy drinking when they stop (or reduce) drinking for 30 days, and whether changes continue for up to 90 days. The study will also identify barriers and facilitators related to drinking reduction. The project will focus on clinical comorbidities including HIV disease control, cognitive and brain function, liver abnormalities, and chronic inflammation. The study teams propose to enroll 140 HIV+ and 40 HIV- adults with heavy drinking, and then use Contingency Management (CM) with financial incentives to encourage participants to maximally reduce alcohol consumption for 30 days. Participants will be required to wear an ankle biosensor (SCRAM monitor) at all times, which is used to monitor participants' drinking behavior. At 30 days, participants will complete a full day of follow-up, including cognitive testing, neuroimaging, blood testing, liver Fibroscan, and questionnaires. Many participants will also provide a stool sample for gut microbiome assessment at each time point. At 30 days, participants will participate in a motivational interview to discuss perceived benefits and obstacles to drinking reduction, and most participants will continue CM to 90 days (but can opt out at this point). Participants will complete another full-day assessment at 90 days, at which point persons may choose to drink or not on their own (no more CM). A final assessment will be conducted at 12 months. This A-B-A design will enable us to clearly identify whether alcohol effects on cognition and brain function are reversible in the context of HIV, and analyze specific cerebral and systemic pathophysiological factors contributing to these effects. The inclusion of HIV- adults will enable subgroup comparisons of alcohol reduction effects in the context of HIV vs. no-HIV. These HIV-negative participants will be recruited from the same settings as our HIV+ participants, and will include a similar proportion by age, race, and gender as the HIV+ participants. The study team will use information from the MI data and our other assessments to elucidate factors that predict both short term (during CM) and long-term (1-year) alcohol reductions, and study how changes in alcohol consumption affect important HIV clinical outcomes that will be monitored over time.

Conditions

• Alcohol Drinking
• Chronic Inflammation
• Neurocognitive Dysfunction
• Liver Diseases
• HIV Infections

Interventions

BEHAVIORAL

Contingency Management (CM)

A reinforcement delivery method that involves financial incentive to participants for sustained alcohol abstinence. CM will start after the participants complete the baseline measures and last for at least 30 days and up to 90 days.

Sponsors & Collaborators

• University of Miami

  collaborator OTHER

• Florida International University

  collaborator OTHER

• Brown University

  collaborator OTHER

• National Institute on Alcohol Abuse and Alcoholism (NIAAA)

  collaborator NIH

• University of Florida

  lead OTHER

Principal Investigators

• Robert Cook · University of Florida

• Ronald Cohen · University of Florida

Study Design

Allocation

NA

Purpose

OTHER

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

50 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-12-11

Primary Completion

2022-08-01

Completion

2024-01-01

Countries

• United States

Study Locations