Alcohol UseNCT05247788
Impaired Risk Awareness During Intoxication in DUI Offenders
A study testing Blood alcohol concentration (BAC) discrimination training and Performance feedback training in people with Alcohol Use, run by Mark Fillmore at 1 site in United States.
Trial summary
This study aims to test the efficacy of experiential-based training to increase DUI offenders' perceptions or risk associated with alcohol use. Read more about this study
- Who is it for?
- Ages 21 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use
- What is being tested?
- Blood alcohol concentration (BAC) discrimination training and Performance feedback training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2022to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Valid driver's license for at least 5 years
- Drive regularly (weekly basis)
Who cannot join
- History of physical or psychiatric disease
- Pregnancy
- Breastfeeding
- Substance use disorder (other than nicotine or caffeine use)
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to test the efficacy of experiential-based training to increase DUI offenders' perceptions or risk associated with alcohol use.
Read the detailed description
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).
- Conditions
- Alcohol Use
- Being tested
- Blood alcohol concentration (BAC) discrimination training, Performance feedback training, Blood alcohol concentration (BAC) discrimination training for controls
- Keywords
- Social drinker
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood alcohol concentration (BAC) discrimination trainingBehavioural
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.
Performance feedback trainingBehavioural
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).
Blood alcohol concentration (BAC) discrimination training for controlsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intoxicated risk awareness training session | Experimental | 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). Receives: Behavioral: Blood alcohol concentration (BAC) discrimination training; Behavioral: Performance feedback training |
| Alcohol exposure only | Active comparator | 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. Receives: Behavioral: Blood alcohol concentration (BAC) discrimination training for controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Post Intervention (up to 14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start2 Feb 2022
- Primary completion1 Mar 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alcohol UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mark Fillmore
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor-investigator, Mark Fillmore, University of Kentucky
- Investigators
- Mark Fillmore, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05247788
- Sponsor's protocol ID
- 60239
- Other IDs
- R01AA028447
- Status last verified
- Mar 2026
- First submitted
- 5 Feb 2022
- Last updated
- 12 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impaired Risk Awareness During Intoxication in DUI Offenders
- ClinicalTrials.gov ID
- NCT05247788
- Acronym / sponsor ID
- 60239
- Conditions
- Alcohol Use
- Keywords
- Social drinker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Mark FillmoreUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 2 Feb 2022 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 21 Feb 2022 (actual)
- Results
- Posted 12 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to test the efficacy of experiential-based training to increase DUI offenders' perceptions or risk associated with alcohol use.
Detailed description
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intoxicated risk awareness training session | Experimental | Behavioral: Blood alcohol concentration (BAC) discrimination training, Behavioral: Performance feedback trainingParticipants 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). |
| Alcohol exposure only | Active comparator | Behavioral: Blood alcohol concentration (BAC) discrimination training for controlsParticipants 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 may qualify
- Ages
- 21 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Valid driver's license for at least 5 years
- Drive regularly (weekly basis)
Key exclusion criteria (4 listed)
- History of physical or psychiatric disease
- Pregnancy
- Breastfeeding
- Substance use disorder (other than nicotine or caffeine use)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood alcohol concentration (BAC) discrimination trainingSubjects 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. | Behavioural | Intoxicated risk awareness training session |
| Performance feedback trainingThis 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). | Behavioural | Intoxicated risk awareness training session |
| Blood alcohol concentration (BAC) discrimination training for controlsSubjects 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. | Behavioural | Alcohol exposure only |
Primary outcome
Mean Number of Alcohol Binges
Time frame: Baseline, 30 and 60 days post intervention
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).
Mean Penn Alcohol Craving Scale (PACS) at Baseline
Time frame: 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.
Mean Penn Alcohol Craving Scale (PACS) Post Intervention
Time frame: Post Intervention (up to 14 days)
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.
Mean Penn Alcohol Craving Scale (PACS) Post Intervention
Time frame: 30 Days 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.
Mean Penn Alcohol Craving Scale (PACS) Post Intervention
Time frame: 60 Days 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.
Mean Multidimensional Assessment of Interoceptive Awareness Ver. 2 (MAIA-2) Scale
Time frame: Baseline (Intervention Session)
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.
Mean Multidimensional Assessment of Interoceptive Awareness (MAIA) Scale
Time frame: Post Intervention (up to 14 days)
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Fillmore, PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood alcohol concentration (BAC) discrimination training and Performance feedback training in people with Alcohol Use, run by Mark Fillmore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Number of Alcohol Binges (time frame: Baseline, 30 and 60 days post intervention). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.