An interventional study of Blood alcohol concentration (BAC) discrimination training and Performance feedback training in Alcohol Use, sponsored by Mark Fillmore. Completed at 1 site in United States. Open to female participants aged 21 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-12.
Sponsored by Mark Fillmore · Not applicable, Interventional, and Prevention
This study aims to test the efficacy of experiential-based training to increase DUI offenders' perceptions or risk associated with alcohol use.
This project examines the efficacy of a laboratory-based intervention to increase risk awareness of DUI offenders during states of acute alcohol intoxication. The proposed research will test the efficacy of an innovative experiential-based training approach to improve DUI offenders' ability to appraise their level of intoxication and enhance their risk awareness. DUI offenders will undergo experiential-based training in which they are administered a controlled dose of alcohol and receive structured feedback and mindfulness-based training to accurately appraise the impairing effects of alcohol and estimate their breath alcohol concentration. The research tests the hypothesis that the experiential training will increase DUI offenders' risk awareness in the intoxicated state as evident by reduced disinhibition and risk-taking behavior in response to alcohol, and reduced self-reported alcohol consumption over a follow up period.
A total of 60 DUI offenders and 60 non-offender controls will be recruited. The study tests the degree to which acute alcohol intoxication impairs key indicators of risk awareness in DUI offenders and the efficacy of experiential feedback to increase risk awareness during intoxication. Two key indicators of impaired risk awareness will be assessed during intoxication: 1) increased disinhibition/risk-taking and; 2) reduced perception of intoxication. Two main hypotheses are tested. Hypothesis 1: Prior to training, DUI offenders will display greater disinhibition/risk-taking and less perceived impairment in response to alcohol compared with controls. Hypothesis 2: Experiential feedback training will increase intoxicated risk awareness among DUI offenders as evident by reduced disinhibiting and risk-taking effects in response to alcohol and increased perception of impairment and accuracy of BAC estimation. Offenders and controls will undergo a pre-training assessment of their responses to a controlled dose of 0.65 g/kg alcohol versus a placebo on the two key indicators of risk awareness: disinhibition/risk-taking and perceived intoxication. Experiential feedback training sessions will begin within one week of completing the pre-training assessment of intoxicated risk awareness. Subjects will attend two training sessions in which they are administered a controlled dose of alcohol and receive structured training to accurately estimate their breath alcohol concentration and accurately appraise the behavioral impairing effects of alcohol. Half of the DUI offenders (20 men and 10 women) will be randomly assigned to the training condition and the other half assigned to an alcohol-exposure-only "control" condition. Non-offender, control subjects will undergo the same group assignment procedure. After completing the two training sessions all subjects will be re-tested on the two indicators of risk awareness in response to 0.65 g/kg alcohol: disinhibition/risk-taking and perceived intoxication. The post-training assessment of alcohol responses is identical to the pre-training assessment and will be conducted at 2 time points: 1-week post-training and 3 months post-training, to evaluate retention effects. Alcohol consumption also will be assessed at monthly intervals over the 3 month follow-up to evaluate the training efficacy to reduce high-risk patterns of consumption (e.g., binge episodes).
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Exclusion Criteria:
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).
Behavioral: Blood alcohol concentration (BAC) discrimination training · Behavioral: Performance feedback training
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.
Behavioral: Blood alcohol concentration (BAC) discrimination training for controls
Subjects will receive 0.65 g/kg alcohol to yield a peak BAC of 85 mg/dl (0.085%). They will be trained to accurately estimate their BAC using the Body Scan Exercise with BAC feedback.
This training element targets the driver's self-efficacy by increasing their awareness of the behavioral impairing effects of alcohol that are experienced at BACs at and even below the legal limit (50-80 mg/dl).
Subjects will receive 0.65 g/kg alcohol to yield a peak BAC of 85 mg/dl (0.085%). They will be given a general Body Scan Exercise with no feedback.
Mean Number of Alcohol Binges
Alcohol consumption will be assessed at monthly intervals from baseline to follow up and will be measured using a timeline follow back assessment. Participants will self-report data on number of days when the participant demonstrates binge drinking (5+ drinks per day for men; 4+ drinks per day for women).
Time frame: Baseline, 30 and 60 days post intervention
Mean Penn Alcohol Craving Scale (PACS) at Baseline
Change in tonic alcohol cravings over the past week will be assessed using the Penn Alcohol Craving Scale (PACS) which is a five-item self-report indicated with strong psychometrics. 'Frequency' is the frequency of craving with a score on a Likert scale ranging from 0 to 6 with higher scores meaning worse craving. 'Strong' is the intensity of craving with a score on a Likert scale ranging from 0 to 6 with higher scores meaning worse craving. 'Time' is the duration of craving with a score on a Likert scale ranging from 0 to 6 with higher scores meaning worse craving. 'Resist' is the inability to resist craving with a score on a Likert scale ranging from 0 to 6 with higher scores meaning worse craving. 'Crave' is overall craving with a score on a Likert scale ranging from 0 to 6 with higher scores meaning worse craving. PACS uses a 0-6 point Likert scale for each item where a higher number for each of the five items indicates more cravings. Total scores range from 0 to 30.
Time frame: Baseline
Mean Penn Alcohol Craving Scale (PACS) Post Intervention
Change in tonic alcohol cravings over the past week will be assessed using the Penn Alcohol Craving Scale (PACS) which is a five-item self-report indicated with strong psychometrics. 'Frequency' is the frequency of craving with a score on a Likert scale ranging from 0 to 6 with higher scores meaning worse craving. 'Strong' is the intensity of craving with a score on a Likert scale ranging from 0 to 6 with higher scores meaning worse craving. 'Time' is the duration of craving with a score on a Likert scale ranging from 0 to 6 with higher scores meaning worse craving. 'Resist' is the inability to resist craving with a score on a Likert scale ranging from 0 to 6 with higher scores meaning worse craving. 'Crave' is overall craving with a score on a Likert scale ranging from 0 to 6 with higher scores meaning worse craving. PACS uses a 0-6 point Likert scale for each item where a higher number for each of the five items indicates more cravings. Total scores range from 0 to 30.
Time frame: Post Intervention (up to 14 days)
Mean Penn Alcohol Craving Scale (PACS) Post Intervention
Change in tonic alcohol cravings over the past week will be assessed using the Penn Alcohol Craving Scale (PACS) which is a five-item self-report indicated with strong psychometrics. 'Frequency' is the frequency of craving with a score on a Likert scale ranging from 0 to 6 with higher scores meaning worse craving. 'Strong' is the intensity of craving with a score on a Likert scale ranging from 0 to 6 with higher scores meaning worse craving. 'Time' is the duration of craving with a score on a Likert scale ranging from 0 to 6 with higher scores meaning worse craving. 'Resist' is the inability to resist craving with a score on a Likert scale ranging from 0 to 6 with higher scores meaning worse craving. 'Crave' is overall craving with a score on a Likert scale ranging from 0 to 6 with higher scores meaning worse craving. PACS uses a 0-6 point Likert scale for each item where a higher number for each of the five items indicates more cravings. Total scores range from 0 to 30.
Time frame: 30 Days Post-Intervention
Mean Penn Alcohol Craving Scale (PACS) Post Intervention
Change in tonic alcohol cravings over the past week will be assessed using the Penn Alcohol Craving Scale (PACS) which is a five-item self-report indicated with strong psychometrics. 'Frequency' is the frequency of craving with a score on a Likert scale ranging from 0 to 6 with higher scores meaning worse craving. 'Strong' is the intensity of craving with a score on a Likert scale ranging from 0 to 6 with higher scores meaning worse craving. 'Time' is the duration of craving with a score on a Likert scale ranging from 0 to 6 with higher scores meaning worse craving. 'Resist' is the inability to resist craving with a score on a Likert scale ranging from 0 to 6 with higher scores meaning worse craving. 'Crave' is overall craving with a score on a Likert scale ranging from 0 to 6 with higher scores meaning worse craving. PACS uses a 0-6 point Likert scale for each item where a higher number for each of the five items indicates more cravings. Total scores range from 0 to 30.
Time frame: 60 Days Post-Intervention
Mean Multidimensional Assessment of Interoceptive Awareness Ver. 2 (MAIA-2) Scale
The Multidimensional Assessment of Interoceptive Awareness Ver. 2 (MAIA-2) is a 37-item self-report measure of 8 dimensions of self-perceived interoceptive ability. The dimensions are: Notice (awareness of uncomfortable, comfortable, or neutral body sensations), Not Distracted (tendency not to ignore or distract oneself from sensations of pain or discomfort), Not Worried (tendency not to worry or experience emotional distress with sensations of pain or discomfort), Attention Regulation (ability to sustain and control attention to body sensations), Emotion (awareness of the connection between body sensations and emotional states), Self-Regulation (ability to regulate distress by attention to body sensations), Body (tendency to actively "listen" to the body for insight), and Trust (experience of one's body as safe and trustworthy). The minimum score for each of the eight dimensions is 0 while the maximum score is 5, with higher scores indicating better outcomes/greater interoception.
Time frame: Baseline (Intervention Session)
Mean Multidimensional Assessment of Interoceptive Awareness (MAIA) Scale
The Multidimensional Assessment of Interoceptive Awareness Ver. 2 (MAIA-2) is a 37-item self-report measure of 8 dimensions of self-perceived interoceptive ability. The dimensions are: Notice (awareness of uncomfortable, comfortable, or neutral body sensations), Not Distracted (tendency not to ignore or distract oneself from sensations of pain or discomfort), Not Worried (tendency not to worry or experience emotional distress with sensations of pain or discomfort), Attention Regulation (ability to sustain and control attention to body sensations), Emotion (awareness of the connection between body sensations and emotional states), Self-Regulation (ability to regulate distress by attention to body sensations), Body (tendency to actively "listen" to the body for insight), and Trust (experience of one's body as safe and trustworthy). The minimum score for each of the eight dimensions is 0 while the maximum score is 5, with higher scores indicating better outcomes/greater interoception.
Time frame: Post Intervention (up to 14 days)
| Milestone | Intervention Group | No Intervention Group |
|---|---|---|
| Started | 55 | 57 |
| Completed | 55 | 57 |
| Not completed | 0 | 0 |
| Milestone | Intervention Group | No Intervention Group |
|---|---|---|
| Started | 55 | 57 |
| Completed | 55 | 57 |
| Not completed | 0 | 0 |
| Milestone | Intervention Group | No Intervention Group |
|---|---|---|
| Started | 55 | 57 |
| Completed | 51 | 53 |
| Not completed | 4 | 4 |
| Withdrew: Withdrawal by subject | 4 | 4 |
Alcohol consumption will be assessed at monthly intervals from baseline to follow up and will be measured using a timeline follow back assessment. Participants will self-report data on number of days when the participant demonstrates binge drinking (5+ drinks per day for men; 4+ drinks per day for women).
| Alcohol Binges | Intervention Group | No Intervention Group |
|---|---|---|
| Baseline/Orientation (T1) | 3.36 ± 3.57 | 4.05 ± 3.68 |
| 30 days post intervention (T2) | 2.69 ± 3.20 | 3.98 ± 3.41 |
| 60 days post intervention (T3) | 2.45 ± 2.62 | 3.57 ± 3.34 |
Change in tonic alcohol cravings over the past week will be assessed using the Penn Alcohol Craving Scale (PACS) which is a five-item self-report indicated with strong psychometrics. 'Frequency' is the frequency of craving with a score on a Likert scale ranging from 0 to 6 with higher scores meaning worse craving. 'Strong' is the intensity of craving with a score on a Likert scale ranging from 0 to 6 with higher scores meaning worse craving. 'Time' is the duration of craving with a score on a Likert scale ranging from 0 to 6 with higher scores meaning worse craving. 'Resist' is the inability to resist craving with a score on a Likert scale ranging from 0 to 6 with higher scores meaning worse craving. 'Crave' is overall craving with a score on a Likert scale ranging from 0 to 6 with higher scores meaning worse craving. PACS uses a 0-6 point Likert scale for each item where a higher number for each of the five items indicates more cravings. Total scores range from 0 to 30.
| score on a scale | Intervention Group | No Intervention Group |
|---|---|---|
| Frequency | 1.75 ± 1.0 | 1.77 ± 1.07 |
| Strong | 1.62 ± 1.22 | 1.49 ± 1.07 |
| Time | 1.22 ± 0.81 | 1.30 ± 0.78 |
| Resist | 0.44 ± 0.81 | 0.39 ± 0.84 |
| Crave | 1.8 ± 0.91 | 1.79 ± 0.96 |
Change in tonic alcohol cravings over the past week will be assessed using the Penn Alcohol Craving Scale (PACS) which is a five-item self-report indicated with strong psychometrics. 'Frequency' is the frequency of craving with a score on a Likert scale ranging from 0 to 6 with higher scores meaning worse craving. 'Strong' is the intensity of craving with a score on a Likert scale ranging from 0 to 6 with higher scores meaning worse craving. 'Time' is the duration of craving with a score on a Likert scale ranging from 0 to 6 with higher scores meaning worse craving. 'Resist' is the inability to resist craving with a score on a Likert scale ranging from 0 to 6 with higher scores meaning worse craving. 'Crave' is overall craving with a score on a Likert scale ranging from 0 to 6 with higher scores meaning worse craving. PACS uses a 0-6 point Likert scale for each item where a higher number for each of the five items indicates more cravings. Total scores range from 0 to 30.
| score on a scale | Intervention Group | No Intervention Group |
|---|---|---|
| Frequency | 1.74 ± 1.0 | 1.64 ± 0.9 |
| Strong | 1.69 ± 1.26 | 1.74 ± 1.26 |
| Time | 1.37 ± 1.03 | 1.32 ± 0.87 |
| Resist | 0.48 ± 0.89 | 0.62 ± 1.04 |
| Crave | 1.54 ± 1.0 | 1.75 ± 0.92 |
Change in tonic alcohol cravings over the past week will be assessed using the Penn Alcohol Craving Scale (PACS) which is a five-item self-report indicated with strong psychometrics. 'Frequency' is the frequency of craving with a score on a Likert scale ranging from 0 to 6 with higher scores meaning worse craving. 'Strong' is the intensity of craving with a score on a Likert scale ranging from 0 to 6 with higher scores meaning worse craving. 'Time' is the duration of craving with a score on a Likert scale ranging from 0 to 6 with higher scores meaning worse craving. 'Resist' is the inability to resist craving with a score on a Likert scale ranging from 0 to 6 with higher scores meaning worse craving. 'Crave' is overall craving with a score on a Likert scale ranging from 0 to 6 with higher scores meaning worse craving. PACS uses a 0-6 point Likert scale for each item where a higher number for each of the five items indicates more cravings. Total scores range from 0 to 30.
| score on a scale | Intervention Group | No Intervention Group |
|---|---|---|
| Frequency | 1.56 ± 0.90 | 1.51 ± 0.95 |
| Strong | 1.62 ± 1.29 | 1.64 ± 1.15 |
| Time | 1.29 ± 0.96 | 1.21 ± 0.84 |
| Resist | 0.73 ± 1.12 | 0.55 ± 0.97 |
| Crave | 1.69 ± 1.16 | 1.57 ± 0.95 |
Change in tonic alcohol cravings over the past week will be assessed using the Penn Alcohol Craving Scale (PACS) which is a five-item self-report indicated with strong psychometrics. 'Frequency' is the frequency of craving with a score on a Likert scale ranging from 0 to 6 with higher scores meaning worse craving. 'Strong' is the intensity of craving with a score on a Likert scale ranging from 0 to 6 with higher scores meaning worse craving. 'Time' is the duration of craving with a score on a Likert scale ranging from 0 to 6 with higher scores meaning worse craving. 'Resist' is the inability to resist craving with a score on a Likert scale ranging from 0 to 6 with higher scores meaning worse craving. 'Crave' is overall craving with a score on a Likert scale ranging from 0 to 6 with higher scores meaning worse craving. PACS uses a 0-6 point Likert scale for each item where a higher number for each of the five items indicates more cravings. Total scores range from 0 to 30.
| score on a scale | Intervention Group | No Intervention Group |
|---|---|---|
| Frequency | 1.53 ± 1.02 | 1.55 ± 1.04 |
| Strong | 1.63 ± 1.20 | 1.49 ± 1.23 |
| Time | 1.41 ± 0.89 | 1.18 ± 0.73 |
| Resist | 0.71 ± 1.0 | 0.57 ± 0.96 |
| Crave | 1.63 ± 1.11 | 1.45 ± 0.96 |
The Multidimensional Assessment of Interoceptive Awareness Ver. 2 (MAIA-2) is a 37-item self-report measure of 8 dimensions of self-perceived interoceptive ability. The dimensions are: Notice (awareness of uncomfortable, comfortable, or neutral body sensations), Not Distracted (tendency not to ignore or distract oneself from sensations of pain or discomfort), Not Worried (tendency not to worry or experience emotional distress with sensations of pain or discomfort), Attention Regulation (ability to sustain and control attention to body sensations), Emotion (awareness of the connection between body sensations and emotional states), Self-Regulation (ability to regulate distress by attention to body sensations), Body (tendency to actively "listen" to the body for insight), and Trust (experience of one's body as safe and trustworthy). The minimum score for each of the eight dimensions is 0 while the maximum score is 5, with higher scores indicating better outcomes/greater interoception.
| score on a scale | Intervention Group | No Intervention Group |
|---|---|---|
| Notice | 3.64 ± 0.73 | 3.51 ± 0.78 |
| Not Distracted | 1.83 ± 0.79 | 1.81 ± 0.83 |
| Not Worried | 2.96 ± 0.65 | 2.81 ± 0.78 |
| Attention Regulation | 3.18 ± 0.74 | 3.37 ± 0.78 |
| Emotional Regulation | 3.45 ± 0.91 | 3.4 ± 0.87 |
| Self Regulation | 3.13 ± 0.95 | 3.06 ± 0.99 |
| Body | 2.23 ± 1.16 | 2.37 ± 1.09 |
| Trust | 3.86 ± 0.88 | 4.14 ± 0.84 |
The Multidimensional Assessment of Interoceptive Awareness Ver. 2 (MAIA-2) is a 37-item self-report measure of 8 dimensions of self-perceived interoceptive ability. The dimensions are: Notice (awareness of uncomfortable, comfortable, or neutral body sensations), Not Distracted (tendency not to ignore or distract oneself from sensations of pain or discomfort), Not Worried (tendency not to worry or experience emotional distress with sensations of pain or discomfort), Attention Regulation (ability to sustain and control attention to body sensations), Emotion (awareness of the connection between body sensations and emotional states), Self-Regulation (ability to regulate distress by attention to body sensations), Body (tendency to actively "listen" to the body for insight), and Trust (experience of one's body as safe and trustworthy). The minimum score for each of the eight dimensions is 0 while the maximum score is 5, with higher scores indicating better outcomes/greater interoception.
| score on a scale | Intervention Group | No Intervention Group |
|---|---|---|
| Notice | 3.53 ± .67 | 3.46 ± .83 |
| Not Distracted | 1.83 ± .85 | 1.79 ± .83 |
| Not Worried | 2.93 ± .64 | 2.76 ± .64 |
| Attention Regulation | 3.15 ± .74 | 3.36 ± .87 |
| Emotional Regulation | 3.56 ± .77 | 3.48 ± .9 |
| Self Regulation | 3.10 ± .91 | 3.20 ± .91 |
| Body | 2.5 ± .98 | 2.64 ± 1.02 |
| Trust | 3.85 ± .88 | 4.08 ± .86 |
Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intoxicated Risk Awareness Training Session | 0/55 (0%) | 0/55 (0%) | 0/55 (0%) |
| Alcohol Exposure Only | 0/57 (0%) | 0/57 (0%) | 0/57 (0%) |
| Age, Continuous(years) | Intervention Group | No Intervention Group | Total |
|---|---|---|---|
| Mean | 26 ± 5.9 | 24 ± 4.6 | 25 ± 5.3 |
| Sex: Female, Male(Participants) | Intervention Group | No Intervention Group | Total |
|---|---|---|---|
| Female | 26 | 32 | 58 |
| Male | 29 | 25 | 54 |
| Ethnicity (NIH/OMB)(Participants) | Intervention Group | No Intervention Group | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 0 | 3 |
| Not Hispanic or Latino | 51 | 57 | 108 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Intervention Group | No Intervention Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 1 | 4 |
| White | 44 | 50 | 94 |
| More than one race | 6 | 6 | 12 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Region of Enrollment(Participants) | Intervention Group | No Intervention Group | Total |
|---|---|---|---|
| United States | 55 | 57 | 112 |
| Blood Alcohol Content(percentage of alcohol in blood) | Intervention Group | No Intervention Group | Total |
|---|---|---|---|
| Mean | .072 ± 0.016 | .072 ± 0.015 | .072 ± 0.015 |
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Mark Fillmore