Risk Awareness Training for Alcoholism

Overseen By Study Coordinator

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Mark Fillmore

Disqualifiers: Physical disease, Psychiatric disease, Pregnancy, others

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

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a training program designed to help people better understand the risks of drinking and driving. It includes various training methods, such as estimating blood alcohol concentration (BAC) and understanding alcohol's impact on performance. The study has two groups: one experiences only alcohol exposure, while the other receives detailed feedback and training. It suits individuals who have held a driver's license for at least five years and drive regularly. As an unphased trial, this study allows participants to contribute to important research that could enhance public safety and personal awareness.

Will I have to stop taking my current medications?

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

What prior data suggests that this training is safe for participants?

Research shows that blood alcohol concentration (BAC) training is generally safe. This training helps participants estimate their BAC after drinking. Studies have found that it increases awareness of alcohol's effects without causing significant problems.

The training is non-invasive, involving no medical procedures. It focuses on enhancing understanding of personal alcohol levels. The goal is to improve safety by increasing awareness of alcohol's effects.

Past studies on similar training methods have reported no serious safety issues. Most participants handle the training well. For those considering joining a trial like this, evidence suggests it is a safe choice. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Risk Awareness Training for Alcoholism because it introduces a novel approach by focusing on increasing individuals' awareness of their own intoxication levels. Unlike traditional treatments that might focus on abstinence or medication, this approach uses BAC discrimination training and performance feedback to help participants accurately assess their impairment and BAC. This could empower individuals to make safer choices by better understanding their intoxication, potentially reducing risky behaviors associated with drinking.

What evidence suggests that this trial's treatments could be effective for increasing risk awareness in DUI offenders?

Research has shown that training individuals to recognize their blood alcohol concentration (BAC) can improve their ability to judge their alcohol intake. One study found that people with alcohol problems often struggle with this, but training can enhance their accuracy. In this trial, participants in the "Intoxicated Risk Awareness Training Session" arm will receive structured feedback and training to accurately assess the impairing effects of alcohol and estimate their BAC. Meanwhile, participants in the "Alcohol Exposure Only" arm will undergo the same alcohol dose exposures but will not receive feedback on BAC or performance. Training that includes feedback on drinking habits has shown promise, as studies have demonstrated that structured feedback about alcohol use can increase awareness and lead to positive behavior changes. This type of training has been effective in reducing risky drinking, particularly among college students. Together, these methods aim to help individuals understand and manage their alcohol consumption more effectively. ^{2 4 5 6 7}

Who Is on the Research Team?

Mark Fillmore, PhD

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

This trial is for individuals who drive on a weekly basis and have had a valid driver's license for at least five years. It specifically targets DUI offenders to help them understand the risks of alcohol use. Pregnant or breastfeeding individuals, those with substance use disorders (excluding nicotine or caffeine), or with physical or psychiatric diseases cannot participate.

Inclusion Criteria

I have had a valid driver's license for at least 5 years.

I drive on a weekly basis.

Exclusion Criteria

Breastfeeding

I have a history of physical or mental health conditions.

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-training Assessment

Participants undergo a pre-training assessment of their responses to a controlled dose of alcohol versus a placebo on key indicators of risk awareness

1 week

1 visit (in-person)

Training

Participants attend two training sessions where they receive a controlled alcohol dose and structured feedback to appraise the impairing effects of alcohol and estimate BAC

2 weeks

2 visits (in-person)

Post-training Assessment

Participants are re-tested on the indicators of risk awareness in response to alcohol at 1-week and 3-months post-training

3 months

2 visits (in-person)

Follow-up

Participants' alcohol consumption and cravings are monitored monthly to evaluate training efficacy

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Blood alcohol concentration (BAC) discrimination training
• Blood alcohol concentration (BAC) discrimination training for controls
• Performance feedback training

Trial Overview The study is testing two types of training: performance feedback training and blood alcohol concentration discrimination training. The goal is to see if these methods can improve DUI offenders' awareness of the risks associated with drinking and driving.

How Is the Trial Designed?

Group I: Intoxicated risk awareness training session Experimental Treatment 2 Interventions

Participants will complete an intoxicated risk awareness training session in which they receive a controlled alcohol dose with structured feedback and training to accurately appraise the impairing effects of alcohol and estimate their blood alcohol concentration (BAC).

Group II: Alcohol exposure only Active Control 1 Intervention

Participants assigned to the alcohol-exposure-only condition undergo the same alcohol dose exposures over the session but receive a general body scan and do not receive feedback concerning BAC or performance.

Who Is Running the Clinical Trial?

Mark Fillmore

Lead Sponsor

Trials

3

Recruited

250+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Published Research Related to This Trial

BrAC estimation training significantly improved the accuracy of breath alcohol concentration estimates among social drinkers with a recent binge history, indicating its effectiveness in a controlled laboratory setting.

Despite the training's success in improving estimation accuracy, it did not lead to significant changes in actual alcohol consumption or risky behaviors in real-world situations, suggesting limitations in its practical application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breath alcohol estimation training: behavioral effects and predictors of success. Aston, ER., Neiberg, RH., Liguori, A.[2021]

Despite receiving feedback about their blood alcohol level (BAL), 83% of college-aged patrons who were legally intoxicated still chose to drive after leaving a drinking establishment, highlighting a concerning disregard for safety.

The study found a strong correlation (0.82) between self-reported alcohol consumption and Breathalyzer measurements, indicating that individuals were generally accurate in estimating their BAL based on their drinking habits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of feedback on legally intoxicated drivers. Meier, SE., Brigham, TA., Handel, G.[2019]

A study involving 225 college students found that underestimating one's blood alcohol concentration (BAC) was linked to a higher likelihood of experiencing negative consequences related to alcohol consumption.

The results suggest that improving education about BAC could help reduce alcohol-related harms among college students, as underestimation was a significant predictor of negative outcomes beyond just the amount of alcohol consumed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Underestimations of blood alcohol concentration predict event-specific negative consequences. Grant, SP., LaBrie, JW., Hummer, JF., et al.[2015]

Social drinkers trained to recognize their blood alcohol concentrations (BAC) were more likely to predict their performance impairment while drinking compared to untrained individuals.

Despite their heightened awareness of potential impairment, the actual performance on coding tasks did not differ between the trained and untrained groups, suggesting that training may increase caution without affecting task performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-evaluation of performance and the ability to discriminate blood alcohol concentrations. Vogel-Sprott, M.[2019]

A study involving 33 adults showed that providing feedback on blood alcohol concentration (BAC) significantly improved participants' accuracy in estimating their BAC after consuming alcohol.

Mindfulness training combined with BAC feedback further enhanced this accuracy, suggesting that awareness of bodily cues related to intoxication can be beneficial in understanding one's level of impairment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of mindfulness training to improve BAC self-estimation during a drinking episode. Kelly, AR., Fillmore, MT.[2023]

Providing warnings about the risks of drunk driving significantly lowered blood alcohol concentrations (BACs) among participants who planned to drive home, indicating that awareness of risks can effectively reduce drinking behavior.

The 'Know Your Limit' (KYL) BAC estimation cards did not reduce BACs and may have even undermined the effectiveness of the warnings, suggesting that this method is not a reliable tool for preventing drinking and driving.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of providing drinkers with "know your limit" information on drinking and driving: a field experiment. Johnson, MB., Clapp, JD.[2021]

BAC estimation training helps moderate drinkers learn to recognize their blood alcohol concentration levels, which can prevent excessive drinking and reduce the risk of drunk driving.

While dependent drinkers struggle with BAC estimation due to high tolerance, moderate drinkers benefit from this training, making it a valuable tool in drunk driving prevention programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-estimation of blood alcohol concentration: a review. Aston, ER., Liguori, A.[2021]

Alcohol counselors did not consistently outperform mental health counselors in recognizing intoxication levels, indicating that specialized training may not guarantee better recognition of alcohol impairment.

Both less-experienced and more-experienced alcohol counselors struggled to accurately estimate blood alcohol levels, although they were able to identify moderate intoxication at higher levels (BAL of .15%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recognition of intoxication by alcohol counselors. Carroll, N., Rosenberg, H., Funke, S.[2019]

In a study involving 99 bar patrons, participants struggled to accurately estimate their blood alcohol level (BAL), often overestimating their level of intoxication, highlighting a common issue among social drinkers.

Factors such as the drinking environment and the individual's drinking experience influenced their ability to estimate intoxication, with males showing poorer estimation skills compared to females.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experience with alcohol and ability to discriminate legal intoxication status: a field study. Williams, JG.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10907993/

Use of Mindfulness Training to Improve BAC Self- ... The present study aimed to increase drinkers' BAC estimation accuracy after drinking alcohol using mindfulness-based feedback to increase their awareness.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/7377914/

Blood alcohol level discrimination. The effects of family ... Alcoholics seem less able than nonalcoholics to maintain blood alcohol level (BAL) estimation accuracy after discrimination training focused on changes in

3. sciencedirect.com sciencedirect.com/science/article/pii/S0022437525001161

A systematic review on the factors associated with ... This systematic review aimed to synthesize the evidence regarding what factors are associated with the accuracy of self-estimated blood and breath alcohol ...

4. jamanetwork.com jamanetwork.com/HttpHandlers/ArticlePdfHandler.ashx?journal=psych&pdfFileName=archpsyc_37_5_010.pdf

Blood Alcohol Level Discrimination changes in BAL as well as external training subjects. In other words, internal training was less effective than external training with these alcoholic subjects.

5. nature.com nature.com/articles/s41746-021-00441-4

Machine learning prediction of blood alcohol concentration In conclusion, an ML algorithm successfully quantified a digital phenotype of behavior, predicting naturalistic BrAC levels exceeding 0.08 g/dL ...

6. withpower.com withpower.com/trial/phase-alcohol-drinking-1-2022-f8feb

Risk Awareness Training for Alcoholism · Info for Participants This treatment is unique because it focuses on training individuals to accurately estimate their blood alcohol concentration (BAC) and recognize their level of ...

7. uknowledge.uky.edu uknowledge.uky.edu/cgi/viewcontent.cgi?article=1229&context=psychology_etds

experiential-based feedback during alcohol intoxication and ... BAC discrimination training (BDT) to increase self-awareness of alcohol intoxication involves training individuals to better estimate their BAC ...