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

782 Participants Needed

Trial Summary

What is the purpose of this trial?

This study aims to identify risk factors that prospectively predict alcohol problems in young adults.

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.

What data supports the effectiveness of the drug Alcohol, Ethanol, Ethyl alcohol, Placebo, Control, Dummy Treatment for alcohol abuse?

The research suggests that placebo treatments can induce feelings of intoxication, with some subjects experiencing significant placebo effects. Additionally, individuals showed a preference for ethanol over placebo in a controlled setting, indicating that ethanol can influence subjective experiences and preferences. ^{1 2 3 4 5}

Is ethanol generally safe for human use?

Ethanol, when used topically on the skin or in the mouth, can cause irritation and may increase the risk of cancer if consumed orally, but there is no strong evidence linking topical use to cancer. Ethanol can impair psychomotor performance and cause feelings of drunkenness. In research involving alcoholics, ethanol administration has not shown adverse effects, but more independent studies are needed to understand long-term safety. ^{6 7 8 9 10}

How does the drug used in the Alcohol for Alcohol Abuse trial differ from other treatments for alcohol abuse?

This trial is unique because it explores using alcohol itself as a treatment for alcohol abuse, which is unconventional compared to standard treatments that typically involve medications to reduce cravings or withdrawal symptoms. The study examines the effects of alcohol and placebo, focusing on the psychological and physiological responses, which is different from traditional approaches that avoid alcohol consumption. ^{1 2 11 12 13}

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

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

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

2. Germany pubmed.ncbi.nlm.nih.gov

Assessing individual differences in ethanol preference using a cumulative dosing procedure. [2019]

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

Experimental design in alcohol administration research: limitations and alternatives in the manipulation of dosage-set. [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Meta-analyses of placebo-controlled trials of acamprosate for the treatment of alcohol dependence: impact of the combined pharmacotherapies and behavior interventions study. [2011]

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

Outcomes for untreated individuals involved in randomized trials of alcohol treatment. [2022]

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

Effects of ethanol on psychomotor performance under steady-state conditions. [2012]

7. England pubmed.ncbi.nlm.nih.gov

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

8. Switzerland pubmed.ncbi.nlm.nih.gov

Therapeutic Applications of Ethanol: A Review. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Safety evaluation of topical applications of ethanol on the skin and inside the oral cavity. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Ethanol self-administration in males with and without an alcoholic first-degree relative. [2019]

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

Ethanol and pentobarbital: comparison of behavioral and subjective effects in sedative drug abusers. [2019]

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

Early mortality of alcoholic hepatitis: a review of data from placebo-controlled clinical trials. [2021]

13. England pubmed.ncbi.nlm.nih.gov

Psychophysiological effects of oral ethanol in alcoholics and social drinkers. [2019]