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Alcohol Effects on Drinking Behavior (CSDP Trial)
N/A
Recruiting
Led By Andrea C King, PhD
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Weigh between 110-210 lbs
Age 21-65
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Summary
This trial looks at how different people react to alcohol and other substances, and whether this predicts how much they will drink in the future. It also looks at how people's responses to alcohol change if their drinking habits do.
Who is the study for?
This trial is for adults aged 21-65 who weigh between 110-210 lbs and drink alcohol at least once a week, including weekly 'binge' drinking episodes. They must be reachable for follow-ups for two years and able to attend two sessions at the University of Chicago. People with major medical or psychiatric disorders, or alcohol/substance dependence cannot join.
What is being tested?
The study is looking into why young adults might start and keep drinking too much by testing their reactions to alcohol (ethanol) and other substances like Diphenhydramine (an antihistamine) and caffeine compared to a placebo. It also tracks if these responses predict future drinking habits.
What are the potential side effects?
Possible side effects from the substances tested may include drowsiness or alertness from Diphenhydramine and Caffeine respectively, as well as typical effects of intoxication from Ethanol such as impaired coordination, changes in mood, nausea, or headaches.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I weigh between 110 and 210 lbs.
Select...
I am between 21 and 65 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Trial Design
6Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Beverage with Low Alcohol DoseExperimental Treatment1 Intervention
Beverage containing 0.4 g/kg alcohol
Group II: Beverage with Heavy Alcohol DoseExperimental Treatment1 Intervention
Beverage containing 0.8 g/kg alcohol
Group III: Beverage with DiphenhydramineExperimental Treatment1 Intervention
Beverage containing 1.5 standard dose of Diphenhydramine (Benadryl)
Group IV: Beverage with CaffeineExperimental Treatment1 Intervention
Beverage containing the equivalent of 1.5 times participant's average caffeine consumption
Group V: Beverage in Natural EnvironmentActive Control1 Intervention
Participant consumes alcohol containing beverages or non-alcohol beverages in natural environment
Group VI: Beverage with No alcohol (Placebo)Placebo Group1 Intervention
Beverage containing 0.0 g/kg alcohol to act as placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Diphenhydramine
2002
Completed Phase 4
~1170
Caffeine
2014
Completed Phase 3
~2980
Ethanol
2005
Completed Phase 4
~3000
Find a Location
Who is running the clinical trial?
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
835 Previous Clinical Trials
1,081,970 Total Patients Enrolled
University of ChicagoLead Sponsor
1,056 Previous Clinical Trials
760,109 Total Patients Enrolled
Andrea C King, PhDPrincipal InvestigatorUniversity of Chicago
1 Previous Clinical Trials
333 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can attend in-person screenings and experimental sessions at the University of Chicago.I weigh between 110 and 210 lbs.I can be contacted for follow-ups for at least 2 years after sessions.You drink alcohol at least once a week and have episodes of "binge" drinking every week.I am between 21 and 65 years old.You have a history of major medical or psychiatric disorders, including alcohol or substance dependence.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Beverage with No alcohol (Placebo)
- Group 2: Beverage with Caffeine
- Group 3: Beverage in Natural Environment
- Group 4: Beverage with Low Alcohol Dose
- Group 5: Beverage with Heavy Alcohol Dose
- Group 6: Beverage with Diphenhydramine
Awards:
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