Alcohol Effects on Impulsivity in Alcoholism

Recruiting at 1 trial location

Overseen By Jessica Weafer, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase < 1

Sponsor: Jessica Weafer

Must not be taking: Psychotropic medications

Disqualifiers: Serious medical problems, Axis I disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the relationship between impulsivity, personal reactions to alcohol, and Alcohol Use Disorder in young adults. Researchers aim to discover new prevention and treatment methods by reducing impulsivity and the desire to drink. Participants will attend sessions where they receive alcohol and a placebo (a substance with no active effect) to better understand these connections. This trial may suit individuals aged 21-25 who drink regularly and have reached a blood alcohol level above .08% at least once in the last month. As an Early Phase 1 trial, this research focuses on understanding how these interventions work in people, offering participants a chance to contribute to groundbreaking insights.

Will I have to stop taking my current medications?

If you are currently taking psychotropic medications (drugs that affect your mood, thoughts, or behavior), you will need to stop, as the trial excludes those who are using them or have a prescription for them in the past 30 days.

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

Research has shown that administering alcohol through an IV in a controlled setting is common in studies. These studies often compare alcohol to a placebo, such as a saltwater solution, to observe reactions. Some research suggests that impulsiveness may influence how people respond to alcohol. Other studies have found that the brain reacts less to alcohol after repeated exposure.

Generally, alcohol is well-tolerated in these study settings, though side effects can occur. Participants might experience dizziness or nausea, but these effects are usually mild and temporary. The studies are designed to closely monitor participants, ensuring their safety during the trial. Although this trial is in the early stages of research, the controlled environment helps manage any risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how alcohol affects impulsivity in individuals with alcoholism through a unique method. Unlike typical treatments that might involve medications or behavioral therapies to manage alcohol dependency, this approach uses controlled intravenous administration of alcohol and placebo to observe changes in impulsivity. This method allows scientists to directly study the immediate effects of alcohol on behavior, providing insights that could lead to more effective interventions for managing impulsivity in alcoholism. By understanding these dynamics, the trial could pave the way for new strategies to help individuals with alcoholism make better decisions, potentially reducing relapse rates.

What evidence suggests that this trial's treatments could be effective for Alcohol Use Disorder?

This trial will explore the effects of alcohol on impulsivity and subjective response in individuals with Alcohol Use Disorder (AUD). Participants in one arm of the trial will receive alcohol followed by a placebo, then engage in a free-access session to self-administer alcohol and placebo. In the other arm, participants will receive a placebo followed by alcohol, with a similar free-access session. Research has shown that impulsivity and subjective responses to alcohol are connected in ways that might predict or influence AUD. Studies have found that more impulsive individuals often feel more energized and less relaxed after drinking, especially in large quantities. Another study discovered that individuals who felt less control over their drinking reached higher blood alcohol levels when they received alcohol through an IV. These findings suggest that impulsivity and subjective responses to alcohol could be important areas to focus on for developing new treatments to reduce risky drinking behaviors. ^{1 4 6 7 8}

Who Is on the Research Team?

Jessica Weafer, PhD

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

This trial is for young adults aged 21-25 who drink alcohol frequently, reaching a blood alcohol concentration (BAC) of over .08% at least once in the past month. Participants must have been drinking at least twice weekly in the last month and be fluent in English.

Inclusion Criteria

I am between 21 and 25 years old.

Report drinking at least twice weekly in the past 30 days based on responses on the TLFB

Report drinking to an estimated BAC > .08% at least once in the past 30 days based on responses on the Timeline Followback (TLFB)

Exclusion Criteria

Axis I psychiatric disorders including substance use disorder other than mild or moderate alcohol or mild cannabis use disorder

My weight is either below 110 pounds or above 210 pounds.

Positive urine screen for illegal drugs other than cannabis

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Lab Sessions

Participants complete two intravenous administration sessions in the lab receiving alcohol and placebo, followed by a third session with free-access to self-administer alcohol and placebo

3 sessions

3 visits (in-person)

Daily Assessment

Participants engage in seven 10-day daily assessment periods using ecological momentary assessment (EMA) to report alcohol consumption and subjective response

70 days total over 2 years

Follow-up

Participants are monitored for safety and effectiveness after the main trial activities

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Impulsivity Domains and Subjective Response

Trial Overview The study is examining how impulsivity and personal reactions to alcohol may contribute to Alcohol Use Disorder (AUD). It involves giving participants either actual alcohol or a placebo to compare their responses.

How Is the Trial Designed?

Group I: Placebo, Then Alcohol, then Free-access session Experimental Treatment 2 Interventions

participants will complete two intravenous administration sessions in the lab during which they will receive placebo (saline) then alcohol, followed by a third lab session in which they will have free-access to self-administer alcohol (up to 120mg% BrAC) and placebo intravenously for 60 min

Group II: Alcohol, Then Placebo, then Free-access session Experimental Treatment 2 Interventions

participants will complete two intravenous administration sessions in the lab during which they will receive alcohol then placebo (saline), followed by a third lab session in which they will have free-access to self-administer alcohol (up to 120mg% BrAC) and placebo intravenously for 60 min

Who Is Running the Clinical Trial?

Jessica Weafer

Lead Sponsor

Trials

5

Recruited

560+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Published Research Related to This Trial

In a study with 90 healthy alcohol drinkers, acute alcohol administration increased impulsive behavior across three different tasks, but the effects varied depending on the type of task and the alcohol dose.

Specifically, higher doses (0.6 and 0.8 g/kg) significantly increased impulsivity in the continuous performance task, while impulsivity increased over time in the stop-signal and delay-discounting tasks regardless of the dose, indicating that impulsivity is influenced by both the task type and the timing of alcohol effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A test of alcohol dose effects on multiple behavioral measures of impulsivity. Dougherty, DM., Marsh-Richard, DM., Hatzis, ES., et al.[2022]

Alcohol intoxication significantly impairs response inhibition and preparation, as evidenced by increased reaction times and decreased accuracy in a color version of the Eriksen flanker task performed by healthy social drinkers under fMRI.

The study reveals that alcohol primarily affects response-level processing rather than attentional or stimulus-related processing, suggesting that its effects on behavior may be linked to difficulties in self-control and decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Alcohol Intoxication on Response Conflict in a Flanker Task. Marinkovic, K., Rickenbacher, E., Azma, S.[2022]

In a study of 87 heavy drinkers, low-dose alcohol (aimed at a BAC of 0.03%) produced noticeable subjective effects of stimulation and sedation, but these effects were not significantly predicted by impulsivity measures.

While impulsivity showed a trend towards predicting increased sedation, this was likely influenced by boredom rather than a direct relationship, suggesting that subjective responses to alcohol can vary widely even among individuals with similar drinking habits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Self-Reported or Behavioral Impulsivity Predict Subjective Response to Low-Dose Alcohol? Berey, BL., Leeman, RF., Pittman, B., et al.[2020]

In a study of 50 social drinkers, higher impulsivity was linked to greater feelings of sedation after consuming alcohol, suggesting that impulsive individuals may experience more sedative effects rather than stimulating effects from alcohol.

The findings indicate that impulsive drinkers might not feel the stimulating effects of alcohol as strongly, potentially leading them to consume more in search of those stimulating effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Response inhibition impairments predict alcohol-induced sedation. Shannon, EE., Staniforth, ER., McNamara, J., et al.[2022]

In a study involving 24 healthy social drinkers, alcohol was found to increase impulsive behavior specifically on the Experiential Discounting Task (EDT) and the Stop Task, with the highest dose (0.8 g/kg) leading to the most impulsive responses.

The EDT proved to be more sensitive to the effects of alcohol compared to traditional delay discounting measures, indicating that it may be a better tool for assessing how alcohol influences impulsive decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute-alcohol effects on the Experiential Discounting Task (EDT) and a question-based measure of delay discounting. Reynolds, B., Richards, JB., de Wit, H.[2013]

In a study of 105 healthy, non-alcohol dependent young adults, those with higher impulsivity reported stronger stimulant effects and weaker sedative effects from alcohol, especially at higher doses.

The findings suggest that impulsive individuals may be more likely to find alcohol reinforcing, which could increase their risk for developing alcohol-related problems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationships between impulsivity and subjective response in an IV ethanol paradigm. Leeman, RF., Ralevski, E., Limoncelli, D., et al.[2022]

In a study involving 46 women (23 heavy drinkers and 23 light drinkers), alcohol consumption significantly increased impulsivity, particularly in heavy drinkers, suggesting they are more prone to risky behaviors after drinking.

Heavy drinkers reported more positive effects from alcohol and were less sensitive to its negative effects, indicating a higher risk for developing alcohol use disorders and engaging in dangerous behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alcohol increases impulsivity and abuse liability in heavy drinking women. Reed, SC., Levin, FR., Evans, SM.[2021]

DUI offenders exhibited heightened impulsivity and impaired inhibitory control when intoxicated with alcohol, leading to increased risky driving behavior, while control drivers did not show the same level of impulsivity under alcohol influence.

Interestingly, DUI offenders reported feeling less intoxicated than they actually were, which may contribute to their willingness to drive after drinking, highlighting a need for targeted interventions to improve risk awareness in this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

DUI offenders display reduced perception of intoxication and heightened impulsive choice in response to alcohol. Fillmore, MT., Van Dyke, N.[2022]

In a study involving 260 participants from the Chicago Social Drinking Project, impulsivity was found to be a significant predictor of heightened stimulant subjective response to alcohol, particularly among light drinkers.

While impulsive light drinkers experienced stimulant effects similar to heavy drinkers, impulsivity did not predict sedative responses to alcohol, suggesting that impulsivity primarily influences the stimulating effects of alcohol rather than its sedative effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationships between generalized impulsivity and subjective stimulant and sedative responses following alcohol administration. Berey, BL., Leeman, RF., Chavarria, J., et al.[2022]

Active alcoholics show significantly faster discounting of delayed rewards compared to currently abstinent alcoholics and control participants, indicating a strong link between impulsivity and alcohol dependence.

Alcohol rewards are discounted more rapidly than monetary rewards, suggesting that the nature of the reward influences impulsivity, which could inform treatment strategies for addiction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delay discounting of money and alcohol in actively using alcoholics, currently abstinent alcoholics, and controls. Petry, NM.[2019]

Chronic intermittent alcohol exposure in rats leads to impaired impulse control, particularly noticeable after the third cycle of alcohol consumption, with deficits persisting for at least 34 days during abstinence.

Renewed alcohol consumption temporarily improves impulse control, but deficits return during subsequent abstinence, highlighting the complex relationship between alcohol use and impulsivity over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increased impulsivity in rats as a result of repeated cycles of alcohol intoxication and abstinence. Irimia, C., Wiskerke, J., Natividad, LA., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4101083/

Relationships between Impulsivity and Subjective ... Results: Individuals with higher impulsivity reported stronger stimulant and weaker sedative response to alcohol, particularly at the higher dose. Higher ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6776085/

The Relationship between Impaired Control, Impulsivity ... Results showed individuals with higher self-reported impaired control achieved higher blood alcohol concentrations (BAC) during the IV-ASA session and reported ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05929677

Impulsivity Domains and Subjective Response This design enables testing of SR early in a drinking event as a predictor of in-lab and daily alcohol use, along with alcohol use and consequences over time, ...

4. psycnet.apa.org psycnet.apa.org/record/2026-08118-001

A pilot study of impulsivity and subjective alcohol response in ... This pilot study aimed (1) to examine associations between impulsivity domains (impulsive action, impulsive choice, and impulsive personality features) and ...

5. psychiatryonline.org psychiatryonline.org/doi/10.1176/appi.ajp.2020.20030247

Subjective Responses to Alcohol in the Development and ... The findings demonstrate systematic changes in subjective responses to alcohol over time, providing an empirical basis for prevention, early intervention, and ...

6. nature.com nature.com/articles/npp2011206

Subjective and Neural Responses to Intravenous Alcohol ... This study shows that HDs not only experience reduced subjective effects of alcohol, but also demonstrate a blunted response to alcohol in the brain's reward ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/27742833/

Influence of Alcohol Expectancies and Impulsivity - PubMed Results: High-responders showed greater subjective responses during i.v. alcohol self-administration compared with low responders ...

8. sciencedirect.com sciencedirect.com/topics/psychology/alcohol-administration

Alcohol Administration - an overview Alcohol administration is the controlled delivery of alcohol, typically in a controlled setting, to study its effects on blood alcohol concentration (BAC).