Alcohol Effects on Drinking Behavior

(CSDP Trial)

Overseen By Ashley Vena, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Chicago

Disqualifiers: Major medical, psychiatric disorders, others

Compensation: Varies

Number of Visits: Unknown

Duration: 4-6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates why some young adults drink excessively and what sustains this behavior. Researchers are testing how different beverages affect drinking behavior, including non-alcoholic drinks, caffeine, low or heavy alcohol doses, and diphenhydramine (an allergy medicine). They aim to determine if responses to these drinks can predict future drinking habits. Ideal participants drink alcohol at least once a week and frequently engage in binge drinking. Participants must be available for in-person sessions in Chicago and follow-up interviews. As an unphased trial, this study offers a unique opportunity to contribute to understanding drinking behaviors and potentially influence future interventions.

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, since the study excludes individuals with major medical or psychiatric disorders, it might imply that participants should not be on medications for such conditions.

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

Research shows that caffeine is usually safe for healthy adults, but it can be harmful to some individuals. Mixing caffeine with alcohol may lead to increased alcohol consumption, potentially intensifying its effects.

For small amounts of alcohol, such as 0.4 grams per kilogram of body weight, research indicates it can affect attention, particularly in moderate drinkers. This amount is often used in studies to understand alcohol's impact and is usually well-tolerated, though it can still alter behavior.

Larger amounts of alcohol, like 0.8 grams per kilogram, are linked to binge drinking. Studies confirm this amount can cause noticeable changes in behavior and bodily reactions. While generally safe for study participants, it can lead to significant effects typical of heavy drinking.

Diphenhydramine, an ingredient in Benadryl, can cause drowsiness and other side effects. When combined with alcohol, these effects may worsen, leading to serious issues like fainting or loss of coordination. This combination is usually not recommended due to the increased risk.

Each of these substances has different safety levels. Always consider personal health and consult a healthcare professional before joining a study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Chicago Social Drinking Project trial because it explores how various beverage compositions affect drinking behavior differently. Unlike traditional treatments that focus solely on counseling or medication to manage alcohol consumption, this trial examines the impact of beverages containing different substances, like caffeine and diphenhydramine, alongside varying alcohol strengths. By understanding how these components influence drinking habits, researchers hope to gather insights that could lead to more personalized and effective strategies for managing alcohol consumption.

What evidence suggests that this trial's treatments could be effective?

This trial will compare the effects of various beverages on drinking behavior. Research has shown that mixing caffeine with alcohol, one of the experimental arms in this trial, can lead to increased consumption and stronger perceived effects of alcohol. Studies suggest that caffeine might make individuals feel less drunk, prompting them to drink more. Another arm involves low-alcohol drinks, which, while potentially safer than consuming large amounts, still carry risks. Low doses of alcohol can influence mood and behavior, yet they remain risky. Consuming large amounts of alcohol, as tested in the heavy alcohol dose arm, is associated with numerous health problems, and most heavy drinkers do not have alcohol dependence. Mixing diphenhydramine (found in Benadryl) with alcohol, another experimental arm, can exacerbate side effects like drowsiness and coordination issues. These substances have varying effects and risks, which can influence drinking behavior. ^{1 2 3 6 7}

Who Is on the Research Team?

Andrea C King, PhD

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

This trial is for adults aged 21-65 who weigh between 110-210 lbs and drink alcohol at least once a week, including weekly 'binge' drinking episodes. They must be reachable for follow-ups for two years and able to attend two sessions at the University of Chicago. People with major medical or psychiatric disorders, or alcohol/substance dependence cannot join.

Inclusion Criteria

I can attend in-person screenings and experimental sessions at the University of Chicago.

I weigh between 110 and 210 lbs.

I can be contacted for follow-ups for at least 2 years after sessions.

Exclusion Criteria

You have a history of major medical or psychiatric disorders, including alcohol or substance dependence.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Testing

Participants undergo baseline testing to examine subjective and objective response differences to alcohol and other substances

1-2 weeks

Treatment

Participants consume various beverages including placebo, caffeine, low and heavy alcohol doses, and diphenhydramine to assess responses

4-6 weeks

Follow-up

Participants are monitored through longitudinal follow-up interviews to determine future consumption patterns

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Chicago Social Drinking Project

Trial Overview The study is looking into why young adults might start and keep drinking too much by testing their reactions to alcohol (ethanol) and other substances like Diphenhydramine (an antihistamine) and caffeine compared to a placebo. It also tracks if these responses predict future drinking habits.

How Is the Trial Designed?

Group I: Beverage with Low Alcohol Dose Experimental Treatment 1 Intervention

Beverage containing 0.4 g/kg alcohol

Group II: Beverage with Heavy Alcohol Dose Experimental Treatment 1 Intervention

Beverage containing 0.8 g/kg alcohol

Group III: Beverage with Diphenhydramine Experimental Treatment 1 Intervention

Beverage containing 1.5 standard dose of Diphenhydramine (Benadryl)

Group IV: Beverage with Caffeine Experimental Treatment 1 Intervention

Beverage containing the equivalent of 1.5 times participant's average caffeine consumption

Group V: Beverage in Natural Environment Active Control 1 Intervention

Participant consumes alcohol containing beverages or non-alcohol beverages in natural environment

Group VI: Beverage with No alcohol (Placebo) Placebo Group 1 Intervention

Beverage containing 0.0 g/kg alcohol to act as placebo

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4238293/

Caffeinated Alcoholic Beverages – An Emerging Trend in ... Some behavioral evidence suggests that caffeine increases alcohol drinking and binge drinking episodes, which in turn can foster the development of alcohol ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4354945/

The Combined Effects of Alcohol, Caffeine and Expectancies ... Simply expecting to consume caffeine may reduce the effects of alcohol on inattention, and either expecting or consuming caffeine may protect against other ...

3. cdc.gov cdc.gov/alcohol/about-alcohol-use/alcohol-caffeine.html

Effects of Mixing Alcohol and Caffeine Drinking alcohol that is mixed with caffeine can make you drink more, which could make the effects from alcohol stronger.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0376871623011596

Differential consumption of alcohol, caffeine, and ... This preliminary work suggests unique pharmacological and behavioral effects from consuming caffeinated alcohol during adolescence.

5. fda.gov fda.gov/media/169548/download

caffeinated alcoholic beverages (CABs) (10/28/2010) caffeinated alcoholic beverages. This behavior results in greater consumption of alcohol, a behavior that masks sensations of drunkenness ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0091743522002572

Caffeine consumption and onset of alcohol use among ... Over 57% of participants reported using caffeine of 100 mg + daily. · At follow-up, about 14% of participants reported drinking alcohol at least once. · Caffeine ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5445139/

The Safety of Ingested Caffeine: A Comprehensive Review We report that, for healthy adults, caffeine consumption is relatively safe, but that for some vulnerable populations, caffeine consumption could be harmful.