Alcohol Impact on Decision-Making During HIV Risk Situations

Overseen By Beth A Lee, R.N.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Must not be taking: PrEP

Disqualifiers: Alcohol use disorder, Neurological disease, HIV, others

Compensation: Varies

Number of Visits: 4

Duration: 1 day per visit, 2 visits total

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how alcohol affects decision-making in situations that might lead to risky sexual behavior, potentially increasing the risk of contracting HIV. Participants will attend two study visits, where they might consume an alcoholic beverage and undergo MRI scans to observe brain activity. The trial seeks healthy adults who occasionally binge drink but do not have an alcohol use disorder. Participants will engage in tasks simulating real-life decisions about sexual encounters and safety measures. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the chance to contribute to groundbreaking insights.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are currently taking PrEP (a medication to prevent HIV), you would not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that alcohol consumption can affect decision-making and may lead to risky behaviors. Studies have found a link between alcohol use and a higher likelihood of engaging in risky sexual activities, increasing the risk of sexually transmitted diseases (STDs) like HIV.

Consuming two standard drinks a day can raise the risk of health problems, such as liver issues. In this trial, researchers will carefully control the amount of alcohol, and participants will be closely monitored. Medical supervision will be provided, and participants will remain at the clinic for up to six hours after their MRI scans to ensure safety.

While alcohol can have negative effects, the study aims to maintain participant safety by controlling the environment and closely monitoring their health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how alcohol affects decision-making in situations that involve HIV risk. Unlike traditional studies that typically focus on biological or pharmaceutical interventions to prevent HIV, this trial is unique in examining the behavioral and cognitive impacts of alcohol consumption. By comparing the effects of alcohol with a placebo beverage, the study aims to uncover insights into how alcohol may influence risky behaviors, potentially leading to better prevention strategies that address these cognitive aspects directly.

What evidence suggests that this trial's treatments could be effective for understanding alcohol's impact on decision-making in HIV risk situations?

This trial will compare the effects of alcohol consumption with a placebo on decision-making during HIV risk situations. Research has shown that drinking alcohol is linked to risky sexual behaviors, increasing the chance of contracting HIV, the virus that leads to AIDS. Studies have found that people who drink are more likely to engage in unsafe sex, raising the risk of HIV transmission. Alcohol alters brain function, affecting decisions in sexual situations. This can result in less frequent use of protection, such as condoms, during sex. Understanding this connection is crucial to help lower the risk of HIV for those who consume alcohol. ^{1 4 6 7 8}

Who Is on the Research Team?

Reza Momenan, Ph.D.

Principal Investigator

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 21-65 who drink alcohol in moderation (1-7 drinks/week for women, 1-14 for men) and have at least one binge drinking episode per month. It's not open to those seeking alcohol use disorder treatment, with significant head trauma or neurological diseases, abnormal liver tests, HIV positive individuals, pregnant or breastfeeding women, or anyone unable to understand English.

Inclusion Criteria

Having on average one or more binge drinking episodes per month (defined as having consumed four or more drinks on one day if female/ five or more if male based on the most recent measurement within the past 90 days Alcohol Timeline Follow back)

I drink 1-7 drinks a week if female, or 1-14 if male.

I am between 21 and 65 years old.

Exclusion Criteria

HIV positive

You have been diagnosed with a serious mental disorder that affects your thinking and perception.

I have had major head injuries or brain surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Baseline Assessment

Participants complete baseline measures of sexual history, preferences, HIV risk, and knowledge.

1 day

1 visit (in-person)

Treatment

Participants receive either alcohol or placebo beverages and undergo MRI scans while completing tasks.

1 day per visit, 2 visits total

2 visits (in-person)

Follow-up

Participants are monitored for any adverse effects and complete additional assessments.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Alcohol beverage
• Placebo beverage

Trial Overview The study examines the effect of alcohol on brain activity related to decisions about risky sexual behavior. Participants will consume alcoholic or placebo beverages and undergo MRI scans while performing tasks. They'll attend two sessions a month apart and discuss their feelings of intoxication.

How Is the Trial Designed?

Group I: arm one Active Control 1 Intervention

participants receive alcohol beverage

Group II: arm two Placebo Group 1 Intervention

Placebo

Who Is Running the Clinical Trial?

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Lead Sponsor

Trials

865

Recruited

1,091,000+

Published Research Related to This Trial

In a study involving 20 female volunteers, ethanol consumption (0.7 g/kg) impaired accuracy in estimating lengths but did not significantly increase risk-taking behavior in tasks involving cash rewards.

Despite the expected impairments in speed and accuracy due to ethanol, the results indicate that consuming alcohol at levels close to the legal driving limit does not enhance risk-taking tendencies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of ethanol on psychomotor performance and on risk taking behaviour. Farquhar, K., Lambert, K., Drummond, GB., et al.[2017]

In a study involving 27 social drinkers (13 light and 14 moderate), both groups showed a strong preference for ethanol over placebo, with moderate drinkers preferring diazepam over placebo as well.

The results indicated that habitual alcohol consumption influences subjective and behavioral responses to both ethanol and diazepam, with moderate drinkers exhibiting a higher preference for diazepam compared to light drinkers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preference for ethanol and diazepam in light and moderate social drinkers: a within-subjects study. de Wit, H., Doty, P.[2019]

Acute ethanol administration increased impulsivity in mice during a specific attention task (5-CSRTT) under conditions that promote premature responses, but did not affect overall attention or response accuracy.

The increase in impulsivity was linked to the action of ethanol on GABA(A) receptors, as similar effects were observed with the GABA(A) agonist diazepam, while the NMDA antagonist ketamine only affected one strain of mice, indicating different neurotransmitter system involvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ethanol effects on impulsivity in two mouse strains: similarities to diazepam and ketamine. Oliver, YP., Ripley, TL., Stephens, DN.[2021]

In a study of 29 normal volunteers, about one-third consistently chose alcohol over a placebo, indicating that individual preferences for alcohol can vary significantly, which may relate to their vulnerability to excessive use.

Subjects who preferred alcohol reported increased feelings of elation and vigor after consumption, while those who preferred placebo experienced the opposite effects, highlighting the subjective differences in response to alcohol based on individual choice patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individual differences in behavioral and subjective responses to alcohol. de Wit, H., Uhlenhuth, EH., Pierri, J., et al.[2019]

The COMBINE Study is exploring the effectiveness of combining medications (acamprosate and naltrexone) with behavioral treatments for alcohol dependence, and has introduced a new treatment condition (Cell 9) that examines psychotherapy without any medication.

This new condition allows researchers to assess the strength of the placebo effect in alcohol-dependent patients and provides insights into the effectiveness of psychotherapy alone, which is often how treatment is delivered in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a "psychotherapy with no pills" treatment condition as part of a combined pharmacotherapy-psychotherapy research study of alcohol dependence. Weiss, RD., Locastro, JS., Swift, R., et al.[2019]

Research on ethanol administration has provided valuable insights into the mechanisms of alcohol dependence and has improved treatment understanding, with no compelling evidence of adverse effects on participants with alcohol dependence.

An ethical review process is recommended for ethanol administration studies, focusing on respect, beneficence, and justice, and tailoring risk/benefit analyses based on the specific backgrounds of different groups of alcoholic subjects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ethical, scientific and clinical issues in ethanol administration research involving alcoholics as human subjects. Dolinsky, ZS., Babor, TF.[2013]

In a study involving 40 participants (20 males and 20 females), the effects of alcohol consumption were examined using a balanced placebo design, revealing that participants' perceptions of alcohol content were influenced by actual alcohol consumption, regardless of what they were told about the beverage.

The findings suggest that when participants consume a significant dose of alcohol (enough to reach a blood alcohol level of 0.05%), it becomes difficult to separate the effects of alcohol from the expectations set by beverage instructions, indicating a need for careful design in future studies on alcohol effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The balanced placebo design: effects of alcohol and beverage instructions cannot be independently assessed. Lyvers, MF., Maltzman, I.[2019]

In a study of 40 young adults, it was found that individuals were more willing to drive greater distances when their blood alcohol concentration (BAC) was decreasing, indicating a potential misjudgment of safety as intoxication levels change.

Participants' willingness to drive was influenced by their subjective feelings of intoxication, stimulation, and sedation, suggesting that personal perceptions of safety can lead to risky driving decisions even when they recognize the dangers of driving under the influence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Context, acute tolerance, and subjective response affect alcohol-impaired driving decisions. Motschman, CA., Warner, OM., Wycoff, AM., et al.[2021]

Low to moderate alcohol consumption may offer some health benefits, such as reducing the risk of coronary heart disease, but it also carries risks like a higher chance of accidents.

The overall impact of alcohol consumption varies by individual, depending on factors like personal health, age, and social context, making it essential to carefully evaluate both the benefits and risks for each person.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risks and Benefits of Alcohol Use Over the Life Span. Dufour, MC.[2023]

In a study involving male subjects consuming either alcoholic or nonalcoholic beverages, those who actually consumed alcohol reported higher levels of subjective intoxication when their blood alcohol concentration reached 0.04% or higher.

At blood alcohol concentrations below 0.04%, there was no significant difference in intoxication ratings between those who consumed alcohol and those who believed they had consumed alcohol, indicating that expectancy effects can influence perceived intoxication at lower levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Some boundary conditions for effective use of alcohol placebos. Martin, CS., Earleywine, M., Finn, PR., et al.[2019]

Moderate or social drinking, while often considered safe, carries inherent health risks and psychosocial consequences that are not solely determined by the amount of alcohol consumed.

The chapter emphasizes the importance of understanding the complex interactions of various factors that influence the risks associated with alcohol consumption, suggesting that a multidimensional model can aid in early intervention and prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Social drinking as a health and psychosocial risk factor. Anstie's limit revisited. Babor, TF., Kranzler, HR., Lauerman, RJ.[2019]

In three experiments involving ethanol's effects on performance, placebo beverages produced a significant range of perceived intoxication effects, with placebo ratings reaching up to 69% of those during actual alcohol sessions, indicating a notable placebo effect.

The study found that the placebo effect was more pronounced in initial treatment sessions compared to subsequent ones, suggesting that repeated measures designs in drug studies should be approached with caution due to potential biases in perceived efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

On the efficacy of alcohol placebos in inducing feelings of intoxication. O'Boyle, DJ., Binns, AS., Sumner, JJ.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4643391/

The Impact of Alcohol Use and Related Disorders on the HIV ... AUDs are associated with increased HIV risk-taking behaviors [13, 14], delays in HIV diagnosis [15], decreased receipt of ART [16], and decreased adherence to ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3711181/

HIV/AIDS, Comorbidity, and Alcohol - PubMed Central - NIH Alcohol use also influences patient outcomes by increasing the risk for HIV- and antiretroviral-associated comorbidities, including liver disease ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2589537024006242

Alcohol use and HIV suppression after completion of ... Six months of alcohol reduction incentives were effective at promoting no/low alcohol use at 12 months, demonstrating persistent effects post-intervention.

4. bmjopen.bmj.com bmjopen.bmj.com/content/13/6/e070713

Efficacy of alcohol reduction interventions among people ... Introduction Unhealthy alcohol use is associated with a range of adverse outcomes among people with HIV (PWH). Testing the efficacy and promoting the ...

5. pophealthmetrics.biomedcentral.com pophealthmetrics.biomedcentral.com/articles/10.1186/s12963-017-0121-9

Does alcohol use have a causal effect on HIV incidence and ... Alcohol use has been found to be strongly associated with incidence and progression of HIV/AIDS, but the extent to which this association is causal has ...

6. samhsa.gov samhsa.gov/sites/default/files/2025-draft-public-comment-alcohol-intake-health-study.pdf

Scientific Findings of the Alcohol Intake & Health Study for ... At 2 standard drinks per day (28g/day), risks increased substantially for multiple outcomes. Liver cirrhosis showed a 31% increase relative to ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5119641/

Alcohol Use and Human Immunodeficiency Virus (HIV) Infection This narrative review identifies alcohol use as a risk factor for HIV transmission, as well as a factor impacting the clinical manifestations and management of ...

8. hhp.ufl.edu hhp.ufl.edu/wp-content/uploads/sites/65/2025/03/Berry-and-Johnson-2018.pdf

Does being drunk or high cause HIV sexual risk behavior? ... The results of this review suggest a causal role in acute alcohol intoxication increasing HIV sexual risk decision-making. Although evidence is limited with ...