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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 below
Select...
I weigh between 110 and 210 lbs.
Select...
I am between 21 and 65 years old.

CSDP Trial 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
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at 3, 6, 9, 12, 15, 18, 21, 24, 36, 48, and 60 months following the final experimental session for reporting.

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
Caffeine
2014
Completed Phase 3
~2980
Diphenhydramine
2002
Completed Phase 4
~1170
Ethanol
2005
Completed Phase 4
~3000

Find a Location

Who is running the clinical trial?

National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
802 Previous Clinical Trials
1,364,645 Total Patients Enrolled
424 Trials studying Alcoholism
985,068 Patients Enrolled for Alcoholism
University of ChicagoLead Sponsor
1,004 Previous Clinical Trials
818,977 Total Patients Enrolled
Andrea C King, PhDPrincipal InvestigatorUniversity of Chicago
1 Previous Clinical Trials
333 Total Patients Enrolled

Media Library

Ethanol Clinical Trial Eligibility Overview. Trial Name: NCT00961792 — N/A
Ethanol 2023 Treatment Timeline for Medical Study. Trial Name: NCT00961792 — N/A
Alcoholism Research Study Groups: Beverage with No alcohol (Placebo), Beverage with Caffeine, Beverage in Natural Environment, Beverage with Low Alcohol Dose, Beverage with Heavy Alcohol Dose, Beverage with Diphenhydramine
Alcoholism Clinical Trial 2023: Ethanol Highlights & Side Effects. Trial Name: NCT00961792 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What medical issues can be addressed with the administration of Ethanol?

"Ethanol has the potential to ameliorate symptoms of ocular discomfort, pain, and catarrh."

Answered by AI

Is this study accepting participants older than seventy years of age?

"As outlined in the trial's requirements, participants must be aged 21 or older and under 65 to meet eligibility."

Answered by AI

Are there any comparable research initiatives that have utilized ethanol?

"At this time, 80 trials in which ethanol is being researched are active. Out of these investigations, 18 have reached Phase 3 status. Additionally, there are 1889 distinct locations around the world conducting clinical studies on the subject. Notably, many centers for research into Ethanol can be found in West Haven Connecticut."

Answered by AI

How many candidates will be included in this medical experiment?

"Affirmative. The information on clinicaltrials.gov reveals that this therapeutic trial, originally launched on March 1st 2004, is seeking volunteers. In total 400 participants will be accepted across a single site of enrolment."

Answered by AI

Is enrollment still available for this experiment?

"As displayed on clinicaltrials.gov, patients are currently being sought for this medical study that was first published in March 2004 and updated more recently in February 2022."

Answered by AI

Am I able to register for this research venture?

"400 individuals afflicted with alcoholism and between the ages of 21 to 65 are being recruited for this research. Applicants should weigh within a range encompassing 110 to 210 lbs, consume alcohol at least once weekly (with binging episodes) as well as be available for in-person screenings, two 4 hour experimental sessions hosted by the University of Chicago, and post-session follow up interviews over a 2 year period via phone or internet communication."

Answered by AI
Recent research and studies
~22 spots leftby Dec 2024