Acute Neural and Immune Effects of Alcohol in People Living With HIV Infection
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Research Assistant
- Phone Number: 4018636679
- Email: idresearch@lifespan.org
Study Contact Backup
- Name: Principal Investigator
- Phone Number: 401-863-3491
Study Locations
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02912
- Brown University and The Miriam Hospital
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
General Inclusion Criteria:
- 21-60 years old;
- Able to speak and read English at least at 8th grade level;
- Alcohol use ≥.60 g/kg at least once in past year. In standard drinks, this amount translates to 1.9-3.0 drinks for an average-weight female and 2.4-3.9 drinks for an average-weight male.
- Body mass index of 18.5-34.9 kg/m2;
- Lab tests obtained in past year showing no evidence of acute/chronic Hepatitis B or C infection;
- HIV-1 serostatus (positive or negative, depending on group) confirmed by standard clinical testing;
- Able to consume soy and nuts safely (in order to consume the standardized meal).
General Exclusion Criteria:
- History of heavy drinking on a weekly or more frequent basis, with heavy drinking defined per NIAAA guidelines (≥4 drinks for women, ≥5 drinks for men on a given day), in the past two years;
- More than five heavy drinking episodes in past 90 days;
- Seeking or receiving treatment for alcohol/drug use, with exception of smoking cessation treatment;
- Antibiotic use in past 1 month;
- Daily use of non-steroidal anti-inflammatory drugs, which are known to increase gut permeability;
- Disorder of the lower GI tract (e.g., inflammatory bowel disease, ulcerative colitis);
- Positive urine test for amphetamine, cocaine, methamphetamine, opioids, or benzodiazepines (cannabis use will be assessed but is not an exclusion criterion);
- Positive screening for past 12-month drug use disorder, indicated by Drug Abuse Screening Test-10 score >2;
- Current major psychiatric disorder (current major depressive episode, bipolar disorder, psychotic disorder);
- History of fainting, weakness, infection, excessive bruising, or extreme distress from blood draw;
- Safety contraindication for MRI (e.g., metal implant); Note: copper intrauterine devices (IUDs) continue to be excluded due to Brown MRI research facility regulations but other non-metal IUDs are allowed;
- Head trauma with loss of consciousness >10 min;
- Inability to abstain from nicotine for 8 hours in-session;
- For cannabis users: inability to abstain for 48 hours prior to study;
- Pregnant, breastfeeding, or not using effective birth control;
- Any other clinical condition or therapy that, in the physician's opinion, would make subject unsuitable for study or unable to comply with dosing requirement.
HIV-Specific Inclusion Criteria:
- On antiretroviral therapy (ART) for ≥6 mos;
- Labs in past 6 mos showing viral load <100 copies/mL, hemoglobin ≥10.0 g/dL, neutrophil count ≥1,000 cells/μL, and platelet count ≥150,000/μL;
- No active AIDS diagnosis.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Alcohol, ethyl, moderate dose
0.6 gram ethyl alcohol per kilogram of body weight
|
Moderate oral dose of ethyl alcohol
|
|
Placebo Comparator: Placebo
0 gram ethyl alcohol per kilogram of body weight
|
Placebo beverage
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Plasma Biomarker of Microbial Translocation
Time Frame: 0-3 hours
|
Lipopolysaccharide (LPS), measured in pg/ml
|
0-3 hours
|
|
Plasma Biomarkers of Immune Activation
Time Frame: 0-3 hours
|
soluble cluster of differentiation 163 (sCD163), measured in ng/ml
|
0-3 hours
|
|
Cerebral Metabolites
Time Frame: 5 hours
|
Magnetic resonance spectroscopy will be used quantify cerebral metabolites in brain regions of interest, specifically frontal lobe.
Primary metabolites of interest include the summed peak of glutamate and glutamine; choline.
|
5 hours
|
|
White Matter Diffusivity
Time Frame: 5 hours
|
Diffusion-weighted MRI will be used to quantify diffusivity metrics in brain white matter.
Primary outcome is fractional anisotropy (measured on a scale of 0-1, where 1 reflects total anisotropy).
|
5 hours
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Subjective Intoxication
Time Frame: 0-5 hours
|
Intoxication rating scale (0-10), where a higher rating indicates greater subjective feelings of alcohol intoxication.
Participants rate their maximum level of intoxication during the study.
|
0-5 hours
|
|
Cognitive Functioning
Time Frame: 0-2 hours
|
Repeatable Battery for Assessment of Neuropsychological Status standardized scores; Note: this measure was unable to be administered to due coronavirus (COVID-19) pandemic restrictions related to social distancing.
|
0-2 hours
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Mollie Monnig, PhD, Brown University
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Estimated)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Blood-Borne Infections
- Urogenital Diseases
- Genital Diseases
- Pathologic Processes
- Immune System Diseases
- Infections
- RNA Virus Infections
- Virus Diseases
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Drinking Behavior
- Pathological Conditions, Signs and Symptoms
- Behavior
- HIV Infections
- Alcohol Drinking
- Inflammation
- Organic Chemicals
- Alcohols
- Ethanol
Other Study ID Numbers
Other Study ID Numbers
- 1904002429
- P20GM130414 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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