Alcohol for Alcohol Abuse

Overseen By Greta Lyons, BS

Age: 18 - 65

Sex: Any

Trial Phase: Phase < 1

Sponsor: Carnegie Mellon University

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores potential causes of alcohol problems in young adults. Participants will receive either a moderate dose of alcohol (ethanol or ethyl alcohol) or a placebo (a non-alcoholic drink) to help researchers identify risk factors for alcohol misuse. The trial seeks individuals aged 21-29 who currently drink alcohol and own a smartphone. As an Early Phase 1 trial, this research aims to understand how alcohol affects individuals, providing participants an opportunity to contribute to groundbreaking insights.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

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

Research shows that alcohol consumption can impact health both short-term and long-term. In the short term, it may lead to injuries or accidents. Over time, excessive drinking can cause serious health issues like cancer, heart disease, and liver problems. In this study, participants will consume a moderate amount of alcohol, targeting a blood alcohol level of 0.08%.

While any alcohol consumption carries some risk, moderate drinking generally presents a lower risk. Most participants are likely to tolerate the treatment well. As the trial is in an early stage, safety remains a top priority. The safety information gathered will help researchers understand how the body responds to the treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores an unconventional approach to treating alcohol abuse by using alcohol itself in a controlled manner. Unlike standard treatments such as counseling, medications like naltrexone, or behavioral therapies, this method investigates whether administering a moderate dose of alcohol can help manage and reduce alcohol abuse. The unique aspect here is the focus on achieving a targeted blood alcohol concentration (BAC) of .08%, which could reveal new insights into addiction management by potentially retraining the body's response to alcohol. This trial could uncover novel ways of tackling alcohol dependency that differ significantly from current treatment methods.

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

Research shows that alcohol consumption can cause various physical and mental health problems. Heavy drinking is linked to numerous health issues and can even lead to death. Although many individuals with alcohol use disorder (AUD) eventually reduce or quit drinking, this process varies for each person. This trial includes an arm where participants receive a moderate dose of alcohol to study its effects. However, no evidence supports that alcohol consumption helps treat alcohol abuse or related issues. In fact, alcohol often increases the risk of developing these problems. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This study is for young adults aged 21 to 29 who currently drink alcohol and own a smartphone. It's designed to help understand risk factors that may lead to alcohol problems.

Inclusion Criteria

Owns a smartphone

Currently drinks alcohol

I am between 21 and 29 years old.

Exclusion Criteria

[Exclusion criteria are masked from public viewing until data collection is complete. Please contact project managers.]

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Laboratory Session

Participants consume a moderate dose of alcohol or placebo in a social setting and responses are assessed

1 day

1 visit (in-person)

Ambulatory Assessment

Participants complete smartphone surveys during drinking episodes and at random times throughout the day

21 days

Follow-up

Participants are monitored for changes in alcohol use and disorder symptoms

12 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Alcohol
• Placebo

Trial Overview The trial is testing the effects of consuming alcohol versus a placebo on behavior. Participants will be randomly assigned to receive either alcoholic beverages or non-alcoholic lookalikes in order to compare responses.

How Is the Trial Designed?

Group I: Alcohol Beverage Experimental Treatment 1 Intervention

Moderate dose of alcohol (target BAC .08%)

Group II: Placebo Beverage Placebo Group 1 Intervention

Alcohol is already approved in United States, European Union, Canada, Japan, China, Switzerland for the following indications:

Approved in United States as Ethanol for:

• None (not approved as a therapeutic agent)

Approved in European Union as Ethanol for:

• None (not approved as a therapeutic agent)

Approved in Canada as Ethanol for:

• None (not approved as a therapeutic agent)

Approved in Japan as Ethanol for:

• None (not approved as a therapeutic agent)

Approved in China as Ethanol for:

• None (not approved as a therapeutic agent)

Approved in Switzerland as Ethanol for:

• None (not approved as a therapeutic agent)

Who Is Running the Clinical Trial?

Carnegie Mellon University

Lead Sponsor

Trials

80

Recruited

540,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

University of Pittsburgh

Collaborator

Trials

1,820

Recruited

16,360,000+

Penn State University

Collaborator

Trials

380

Recruited

131,000+

Published Research Related to This Trial

Ethanol has therapeutic benefits in various medical applications, including as an antidote for methanol and ethylene glycol poisoning, treatment for alcohol withdrawal syndrome, and as an antiseptic, with a generally positive risk-benefit ratio.

Recent advancements in medical technology have expanded ethanol's use as a precise embolization, sclerosing, or ablation agent, highlighting its effectiveness and safety in these new therapeutic roles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic Applications of Ethanol: A Review. Le Daré, B., Gicquel, T.[2020]

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]

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK436003/

Alcohol Use Disorder: Screening, Evaluation, and Management This loss of control results in negative consequences that impact relationships, physical and mental health, and the ability to fulfill role obligations.

2. who.int who.int/news-room/fact-sheets/detail/alcohol

Alcohol Worldwide, around 2.6 million deaths were caused by alcohol consumption in 2019. Of these, 1.6 million deaths were from noncommunicable diseases ...

3. niaaa.nih.gov niaaa.nih.gov/health-professionals-communities/core-resource-on-alcohol/alcohol-use-disorder-risk-diagnosis-recovery

Alcohol Use Disorder: From Risk to Diagnosis to Recovery Individual paths to recovery vary widely and the majority of people with AUD reduce or resolve their drinking problems over time. Whether you ...

4. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2811435

Pharmacotherapy for Alcohol Use Disorder: A Systematic ... This systematic review and meta-analysis evaluates efficacy and comparative efficacy of 9 therapies for alcohol use disorder (AUD).

5. psychiatryonline.org psychiatryonline.org/doi/full/10.1176/appi.ajp.20230488

Overview of Alcohol Use Disorder | American Journal of ... Heavy drinking, which is also common, contributes to multiple adverse medical, psychiatric, and social outcomes and more than 140,000 deaths ...

6. niaaa.nih.gov niaaa.nih.gov/alcohols-effects-health/alcohol-topics/alcohol-facts-and-statistics

Alcohol Facts and Statistics Find up-to-date statistics on lifetime drinking, past-year drinking, past-month drinking, binge drinking, heavy alcohol use, and high-intensity drinking.

7. cdc.gov cdc.gov/alcohol/about-alcohol-use/index.html

Alcohol Use and Your Health Excessive alcohol use can cause immediate issues like injuries and long-term issues like cancer, heart disease, and liver disease. Drinking ...

8. healthdata.org healthdata.org/research-analysis/health-topics/alcohol-use

Alcohol use 1.34 billion people consumed harmful amounts of alcohol in 2020. 38% of deaths from cirrhosis and other liver diseases are attributable to high alcohol use. 1.8 ...

9. mayoclinic.org mayoclinic.org/healthy-lifestyle/nutrition-and-healthy-eating/in-depth/alcohol/art-20044551

Alcohol use: Weighing risks and benefits Drinking alcohol in any amount carries a health risk. While the risk is low for moderate intake, the risk goes up as the amount you drink goes up.