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

NCT03353701 | Completed DMC

• 3 other identifiers: CED000000011-NU01AA020797-06U01AA026225
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in Neurocognitive Functions

  Change in cognitive performance from baseline to 30-day follow-up. NIH Toolbox Cognition Battery is administered by a research assistant and consists of seven tests assessing memory, attention, cognitive flexibility, processing speed, and executive functioning. Summary scores will be calculated.

  Baseline, 30 Days

Secondary Outcomes (6)

• Change in Neuroinflammation

  Baseline, 30 Days

• Change in Brain Function

  Baseline, 30 Days

• Change in markers of systemic Inflammation

  30 Days

• Change in liver Status

  30 Days

• Change in Drinks/week in the Past 30 Days

  Baseline, 1 Year

Study Arms (1)

Adults with or without HIV infection

OTHER

Participants will be asked to stop drinking for at least 30 and up to 90 days. The study will use Contingency Management (CM) with financial incentives to encourage participants to maximally reduce alcohol consumption.

Behavioral: Contingency Management (CM)

Interventions

Contingency Management (CM) BEHAVIORAL

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.

Adults with or without HIV infection

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women;
• Age: 50-75 yrs.;
• participants will have confirmed HIV (confirmed via baseline bloodwork) and 40 participants will be HIV negative
• English speaking (will have protocol ready in Spanish in 2017);
• Physically mobile;
• Willing to participate in CM to reduce alcohol consumption, and to wear the alcohol biosensor for at least 30 days. All participants will be current, heavy drinkers (\>=14 drinks/week women, \>=21 drinks/week men), confirmed by baseline timeline follow-back, and by having evidence of at least 3 drinking episodes on the alcohol biosensor prior to baseline). Must blow a "zero" on breathalyzer at time of informed consent

You may not qualify if:

• Neurological disorders (e.g., dementia, stroke, seizures, traumatic brain injury).
• Evidence of dementia (MOCA \< 17).
• Past opportunistic brain infection
• Major psychiatric illness (schizophrenia, intractable affective disorder, current substance dependence diagnosis).
• Current major psychiatric disturbance, including severe major depression.
• Unstable medical conditions (e.g., cancer).
• MRI contraindications (e.g., pregnancy, severe claustrophobia, metal implants).
• Physical impairment precluding motor response or lying still.
• Significant history of alcohol withdrawal as indicated by an Alcohol Withdrawal Symptom Checklist score ≥ 23 (within past year).
• Unable to correctly answer a set of questions that demonstrate understanding of key aspects of the study, including the voluntary nature of the study, the purpose of the study, what participants are being asked to do as part of the study, and what are the risks related to participating in the study.

Sponsors & Collaborators

• University of Florida: lead
• University of Miami: collaborator
• Florida International University: collaborator
• Brown University: collaborator
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

Related Publications (2)

• Cook RL, Richards VL, Gullett JM, Lerner BDG, Zhou Z, Porges EC, Wang Y, Kahler CW, Barnett NP, Li Z, Pallikkuth S, Thomas E, Rodriguez A, Bryant KJ, Ghare S, Barve S, Govind V, Devieux JG, Cohen RA; 30-Day Challenge Research Team. Experimentally Induced Reductions in Alcohol Consumption and Brain, Cognitive, and Clinical Outcomes in Older Persons With and Those Without HIV Infection (30-Day Challenge Study): Protocol for a Nonrandomized Clinical Trial. JMIR Res Protoc. 2024 Apr 2;13:e53684. doi: 10.2196/53684.

  PMID: 38564243 DERIVED

• Richards VL, Wang Y, Porges EC, Gullett JM, Leeman RF, Zhou Z, Barnett NP, Cook RL. Using alcohol biosensors and biomarkers to measure changes in drinking: Associations between transdermal alcohol concentration, phosphatidylethanol, and self-report in a contingency management study of persons with and without HIV. Exp Clin Psychopharmacol. 2023 Dec;31(6):991-997. doi: 10.1037/pha0000637. Epub 2023 Jan 16.

  PMID: 36649152 DERIVED

MeSH Terms

Conditions

Alcohol Drinking; Cognition Disorders; Liver Diseases; HIV Infections

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior; Neurocognitive Disorders; Mental Disorders; Digestive System Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Robert Cook

  University of Florida

  PRINCIPAL INVESTIGATOR

• Ronald Cohen

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will serve as their own controls with pre- and post-measures.

Study Record Dates

• First Submitted: November 3, 2017
• First Posted: November 27, 2017
• Study Start: December 11, 2017
• Primary Completion: August 1, 2022
• Study Completion: January 1, 2024
• Last Updated: September 3, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Our documents can be shared once the study begins. Data sharing will be an option for at least 5 years after the study is completed.
• Access Criteria: Contact the principal investigator. In the future, information about how to request data will be on a public website

Locations

US (1)