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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 measured at 3, 6, 9, 12, 15, 18, 21, 24, 36, 48, and 60 months following the final experimental session
Awards & highlights
CSDP Trial 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.Check my eligibility
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.See study design
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.
CSDP Trial 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.
CSDP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured at 3, 6, 9, 12, 15, 18, 21, 24, 36, 48, and 60 months following the final experimental session
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at 3, 6, 9, 12, 15, 18, 21, 24, 36, 48, and 60 months following the final experimental session
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Subjective response to alcohol and other common substances utilizing mood questionnaires in adult drinkers
Secondary outcome measures
Substance Use Behavior Reported During Follow-Up Interviews
CSDP 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
~1140
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
815 Previous Clinical Trials
1,159,071 Total Patients Enrolled
428 Trials studying Alcoholism
777,499 Patients Enrolled for Alcoholism
University of ChicagoLead Sponsor
1,016 Previous Clinical Trials
733,579 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:
This trial has 0 awards, including:Share this study with friends
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