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

20 Participants Needed

Trial Summary

What is the purpose of this trial?

Background: People who binge drink are more likely to have risky sexual encounters, and alcohol changes brain activity associated with reward decisions related to those behaviors. Researchers want to better understand how alcohol s effects on risky sexual behavior that might lead people to contract sexually transmitted diseases (STDs) like HIV, the virus that causes AIDS. Objective: To study how alcohol impacts decisions about engaging in risky sex. Eligibility: Healthy adults ages 21-65 without alcohol use disorder Design: Participants will have 2 study visits, 1 month apart. They will arrive and depart via taxi. They will consume alcohol at 1 visit, chosen at random. At visit 1, participants will answer questions about HIV knowledge, HIV risk behaviors, and sexual interests. They will view pictures of clothed people and pick those they might have sex with. They will think about the person s risk of having an STD and whether they would use a condom during sex. At both visits, participants will sit in a bar-like room and have 2 drinks that may contain alcohol. Then they will have magnetic resonance imaging (MRI) brain scans. For this, they will lie on a table that slides in and out of a metal tube. The scanner makes loud noises; they will get earplugs. They will complete tasks that include looking at pictures and making choices about money. At the beginning of both visits the participants will be screened with urine drug test and pregnancy test. Duiring each visit the participants breath alcohol will be measured, and they will discuss whether they feel intoxicated. Participants will get snacks and stay at the clinic for up to 6 hours after the MRIs.

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.

What data supports the effectiveness of the drug in the clinical trial titled 'Alcohol Impact on Decision-Making During HIV Risk Situations'?

The research shows that people often prefer ethanol over a placebo, indicating that ethanol has noticeable effects on individuals, especially those who drink moderately. This suggests that ethanol can influence decision-making, which is relevant to the trial's focus on decision-making during HIV risk situations. ^{1 2 3 4 5}

Is alcohol generally safe for humans in clinical trials?

Research shows that moderate alcohol consumption can have both risks and benefits, such as protection against heart disease but increased risk of accidents. Studies involving alcohol administration to humans, including those with a history of alcohol dependence, have not shown compelling evidence of adverse effects from participation in such research. ^{1 2 6 7 8}

How does the drug used in the trial differ from other treatments for decision-making in HIV risk situations?

This trial is unique because it examines how alcohol, a common social beverage, affects decision-making in risky situations related to HIV, unlike other treatments that might focus on medical or behavioral interventions. The study uses both alcohol and placebo beverages to understand their impact on judgment and risk-taking, which is not a standard approach for addressing decision-making in HIV risk contexts. ^{1 9 10 11 12}

Research Team

Reza Momenan, Ph.D.

Principal Investigator

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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 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 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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Preference for ethanol and diazepam in light and moderate social drinkers: a within-subjects study. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

The balanced placebo design: effects of alcohol and beverage instructions cannot be independently assessed. [2019]

3. United States 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. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Some boundary conditions for effective use of alcohol placebos. [2019]

5. Germany pubmed.ncbi.nlm.nih.gov

On the efficacy of alcohol placebos in inducing feelings of intoxication. [2019]

6. England pubmed.ncbi.nlm.nih.gov

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

7. United States pubmed.ncbi.nlm.nih.gov

Social drinking as a health and psychosocial risk factor. Anstie's limit revisited. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

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

9. Germany pubmed.ncbi.nlm.nih.gov

Ethanol effects on impulsivity in two mouse strains: similarities to diazepam and ketamine. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Effect of ethanol on psychomotor performance and on risk taking behaviour. [2017]

11. Germany pubmed.ncbi.nlm.nih.gov

Context, acute tolerance, and subjective response affect alcohol-impaired driving decisions. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Individual differences in behavioral and subjective responses to alcohol. [2019]