Alcohol Use Disorder (AUD)Early Phase 1IDEANCT03736343
Impulsivity and Alcohol Response
A Early Phase 1 study testing Alcohol in people with Alcohol Use Disorder (AUD) and Subjective Response to Alcohol (SR), run by University of Florida at 1 site in United States.
Trial summary
Impulsivity, a well-known risk factor predicting negative outcomes, refers broadly to a proclivity towards rapid action with a suboptimal regard for future consequences. Importantly, impulsivity is a multidimensional construct incorporating generalized and behavioral facets. Read more about this study
- Who is it for?
- Ages 21 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder (AUD), Subjective Response to Alcohol (SR)
- What is being tested?
- Alcohol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2019to 17 Oct 2022
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be between the ages of 21-30
- Be able to read English and complete study evaluations
- Drink alcohol regularly
- Be willing to consume vodka-based alcoholic beverages
Who cannot join
- Have positive urine screen results at the in-person screening or on the day of an alcohol drinking session for illegal drugs
- A woman who is pregnant, nursing, or refuses to use a reliable method of birth control.
- A current undergraduate or graduate student at any level in one of the departments that make up the College of Health and Human Performance (HHP) at the University of Florida (UF), where Dr. Leeman's faculty appointment is.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Individual Differences in the Effects of Alcohol (IDEA) Study
Impulsivity, a well-known risk factor predicting negative outcomes, refers broadly to a proclivity towards rapid action with a suboptimal regard for future consequences. Importantly, impulsivity is a multidimensional construct incorporating generalized and behavioral facets. However, underlying mechanisms linking facets of impulsivity to high-risk drinking remain uncertain. Such mechanisms, if uncovered, may be more appropriate intervention targets than impulsivity directly.
Similar to impulsivity, subjective response to alcohol (SR), or individual differences in sensitivity to the pharmacologic effects of alcohol, is an established risk factor for alcohol use disorder. Specifically, experiencing heightened rewarding stimulation and dampened aversive sedation from alcohol are related to high-risk drinking. Theory and recent findings indicate SR and impulsivity may be related, suggesting SR may be a mechanism linking facets of impulsivity to high-risk drinking. However, findings linking impulsivity to SR were all from secondary data analyses and most studies reported on only a single measure of impulsivity. For these reasons, an original data collection using laboratory alcohol administration methods is needed to address which facets of impulsivity are related to SR among young adult drinkers and whether these effects manifest while blood alcohol concentrations are increasing or declining.
This study will utilize a laboratory alcohol administration design to investigate whether distinct facets of impulsivity (i.e., generalized, choice, response) are related to subjective responses (i.e., stimulation and sedation) following alcohol administration.
Read the detailed description
Young adult heavy drinkers, aged 21-30, will enroll in a laboratory alcohol administration study. In a simulated bar laboratory, participants will be administered oral alcohol with three vodka-based drinks. This procedure will allow collection of several measures, notably a widely used, validated measure of self-reported SR and multiple measures capturing facets of impulsive behavior prior to and following alcohol administration. Participants will be recruited through a number of means. Flyers will be posted and handed out in and around the various colleges, universities and technical schools in the Gainesville area as well as in other public areas. The study team will utilize the internet by posting brief solicitation messages on social media, newspaper sites, and classified advertising sites. These same brief messages will also be disseminated to students at the local colleges, universities and technical schools in the area via batch emails and list servs. When permitted, brief recruitment talks will be given verbally during class meetings at these local institutions. Verbal recruitment messages will contain the same material in the appended flyers and other advertisements. Copies of flyers will also be provided at the conclusion of these brief recruitment talks. Potential participants will complete an initial eligibility questionnaire over the phone or online. Participants who appear eligible based on the phone/web screen will be invited to attend an in-person screening appointment. If eligible, participants will be scheduled for two alcohol drinking sessions separated by a minimum of one and a maximum of seven days. After the second drinking session, participants will be scheduled for a follow-up appointment.
- Being tested
- Alcohol
- Keywords
- impulsivity, family history, heavy drinking, blood alcohol content (BAC), breath alcohol content (BrAC)
- Medical subject headings
- Alcoholism, Impulsive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlcoholDrug
Also called 80-proof Vodka Mixed Drinks
Participants will complete two drinking sessions.
| Study group | Role | What they receive |
|---|---|---|
| Young Adult Heavy Drinkers Group 1 | Active comparator | Young adult heavy drinkers, aged 21-30, will be administered varying doses of oral alcohol. Receives: Drug: Alcohol |
| Young Adult Heavy Drinkers Group 2 | Active comparator | Young adult heavy drinkers, aged 21-30, will be administered varying doses of oral alcohol. Receives: Drug: Alcohol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biphasic Alcohol Effects Scale
Biphasic Alcohol Effects Scale is a 14-item, 2-factor model including stimulant and sedative alcohol effects. The minimum value for each of the 2 factors is 0 and the maximum is 70. Higher scores indicate greater stimulation and sedation for each factor, respectively.
Measured: Up to 6 hours
Secondary outcomes (2)
Subjective Effects of Alcohol Scale
The Subjective Effects of Alcohol Scale is a 14-item, 4-factor model including low and high arousal positive and negative alcohol effects. The current study assesses specifically high arousal negative (e.g., aggressive) and low arousal positive (e.g., relaxed) alcohol effects.The factor concerning high arousal negative alcohol effects ranges from 0 - 30, with higher scores indicating greater high arousal negative alcohol effects (e.g., aggression). The factor concerning low arousal positive alcohol effects ranges from 0 - 40, with higher scores indicating greater low arousal positive alcohol effects (e.g., relaxed).
Measured: Up to 6 hours
Alcohol Reward
The Drug Effects Questionnaire will be used to assess the extent to which participants like the effects of alcohol they are experiencing at the time, rated on a 100-mm line (from "not at all" to "very much") and how much they want more alcohol at the time, also rated on a 100-mm line (from "not at all" to "very much").
Measured: Up to 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2018
- Study start1 May 2019
- Primary completion31 May 2020
- Study completion17 Oct 2022
Why it stopped: The COVID-19 outbreak began, precluding further participant recruitment for this protocol, which could only be conducted in-person. A decision was made that ample data was available to end data collection earlier than anticipated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use Disorder (AUD)Studies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), American Psychological Association (APA)
- Responsible party
- Sponsor
- Investigators
- Yan Wang, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03736343
- Sponsor's protocol ID
- IRB201801192 - N
- Other IDs
- OCR16172, 5T32AA025877
- Acronym
- IDEA
- Status last verified
- Nov 2023
- First submitted
- 6 Nov 2018
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individual Differences in the Effects of Alcohol (IDEA) Study
- ClinicalTrials.gov ID
- NCT03736343
- Acronym / sponsor ID
- IDEA / IRB201801192 - N
- Keywords
- impulsivity, family history, heavy drinking, blood alcohol content (BAC), breath alcohol content (BrAC)
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The COVID-19 outbreak began, precluding further participant recruitment for this protocol, which could only be conducted in-person. A decision was made that ample data was available to end data collection earlier than anticipated.
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), American Psychological Association (APA)
- Study start
- 1 May 2019 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 17 Oct 2022 (actual)
- First posted
- 9 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Impulsivity, a well-known risk factor predicting negative outcomes, refers broadly to a proclivity towards rapid action with a suboptimal regard for future consequences. Importantly, impulsivity is a multidimensional construct incorporating generalized and behavioral facets. However, underlying mechanisms linking facets of impulsivity to high-risk drinking remain uncertain. Such mechanisms, if uncovered, may be more appropriate intervention targets than impulsivity directly.
Similar to impulsivity, subjective response to alcohol (SR), or individual differences in sensitivity to the pharmacologic effects of alcohol, is an established risk factor for alcohol use disorder. Specifically, experiencing heightened rewarding stimulation and dampened aversive sedation from alcohol are related to high-risk drinking. Theory and recent findings indicate SR and impulsivity may be related, suggesting SR may be a mechanism linking facets of impulsivity to high-risk drinking. However, findings linking impulsivity to SR were all from secondary data analyses and most studies reported on only a single measure of impulsivity. For these reasons, an original data collection using laboratory alcohol administration methods is needed to address which facets of impulsivity are related to SR among young adult drinkers and whether these effects manifest while blood alcohol concentrations are increasing or declining.
This study will utilize a laboratory alcohol administration design to investigate whether distinct facets of impulsivity (i.e., generalized, choice, response) are related to subjective responses (i.e., stimulation and sedation) following alcohol administration.
Detailed description
Young adult heavy drinkers, aged 21-30, will enroll in a laboratory alcohol administration study. In a simulated bar laboratory, participants will be administered oral alcohol with three vodka-based drinks. This procedure will allow collection of several measures, notably a widely used, validated measure of self-reported SR and multiple measures capturing facets of impulsive behavior prior to and following alcohol administration. Participants will be recruited through a number of means. Flyers will be posted and handed out in and around the various colleges, universities and technical schools in the Gainesville area as well as in other public areas. The study team will utilize the internet by posting brief solicitation messages on social media, newspaper sites, and classified advertising sites. These same brief messages will also be disseminated to students at the local colleges, universities and technical schools in the area via batch emails and list servs. When permitted, brief recruitment talks will be given verbally during class meetings at these local institutions. Verbal recruitment messages will contain the same material in the appended flyers and other advertisements. Copies of flyers will also be provided at the conclusion of these brief recruitment talks. Potential participants will complete an initial eligibility questionnaire over the phone or online. Participants who appear eligible based on the phone/web screen will be invited to attend an in-person screening appointment. If eligible, participants will be scheduled for two alcohol drinking sessions separated by a minimum of one and a maximum of seven days. After the second drinking session, participants will be scheduled for a follow-up appointment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Young Adult Heavy Drinkers Group 1 | Active comparator | Drug: AlcoholYoung adult heavy drinkers, aged 21-30, will be administered varying doses of oral alcohol. |
| Young Adult Heavy Drinkers Group 2 | Active comparator | Drug: AlcoholYoung adult heavy drinkers, aged 21-30, will be administered varying doses of oral alcohol. |
Who may qualify
- Ages
- 21 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Be between the ages of 21-30
- Be able to read English and complete study evaluations
- Drink alcohol regularly
- Be willing to consume vodka-based alcoholic beverages
Key exclusion criteria (3 listed)
- Have positive urine screen results at the in-person screening or on the day of an alcohol drinking session for illegal drugs
- A woman who is pregnant, nursing, or refuses to use a reliable method of birth control.
- A current undergraduate or graduate student at any level in one of the departments that make up the College of Health and Human Performance (HHP) at the University of Florida (UF), where Dr. Leeman's faculty appointment is.
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 |
|---|---|---|
| AlcoholAlso: 80-proof Vodka Mixed DrinksParticipants will complete two drinking sessions. | Drug | Young Adult Heavy Drinkers Group 1, Young Adult Heavy Drinkers Group 2 |
Primary outcome
Biphasic Alcohol Effects Scale
Time frame: Up to 6 hours
Biphasic Alcohol Effects Scale is a 14-item, 2-factor model including stimulant and sedative alcohol effects. The minimum value for each of the 2 factors is 0 and the maximum is 70. Higher scores indicate greater stimulation and sedation for each factor, respectively.
2 secondary outcomes
Subjective Effects of Alcohol Scale
Time frame: Up to 6 hours
Alcohol Reward
Time frame: Up to 6 hours
Results and safety
The study was stopped early (reason given: The COVID-19 outbreak began, precluding further participant recruitment for this protocol, which could only be conducted in-person. A decision was made that ample data was available to end data collection earlier than anticipated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- Individual participant dataSharing planned: No
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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.
Yan Wang principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Alcohol in people with Alcohol Use Disorder (AUD) and Subjective Response to Alcohol (SR), run by University of Florida 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 4 inclusion and 3 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: stopped early, as of the sponsor's last update on 6 Dec 2023. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The COVID-19 outbreak began, precluding further participant recruitment for this protocol, which could only be conducted in-person. A decision was made that ample data was available to end data collection earlier than anticipated.). Results are not available in the source record.
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?
Biphasic Alcohol Effects Scale (time frame: Up to 6 hours). 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 6 Dec 2023.