Ignite Creation Date:
2025-12-24 @ 2:48 PM
Ignite Modification Date:
2026-02-24 @ 3:53 AM
Study NCT ID:
NCT03104959
Status:
TERMINATED
Last Update Posted:
2018-06-11
First Post:
2016-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of NAC in Prevention of Hangover Symptoms; Independent Alcohol Consumption Protocol
Sponsor:
St. Luke's Hospital and Health Network, Pennsylvania
Organization:
Study Overview
Official Title:
Use of N-acetyl Cysteine (NAC) in Alleviation or Prevention of Hangover Symptoms; Independent Alcohol Consumption Protocol
Status:
TERMINATED
Status Verified Date:
2018-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
unable to enroll sufficient number of participants
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a double-blinded study involving healthy non-alcoholic (self-reported) volunteers over the age of 21. Consent is obtained prior to participation in the study while the participant is sober. Volunteers are recruited from residency programs, hospital employees, emergency medical personnel, and friends of the study investigators. If the volunteers choose to drink, they can participate in the study the night of ingestion of alcohol. There is no amount we ask them to drink, and we allow them to withdraw from the study at any time. We never force them to drink alcohol, or even encourage it. The participation is completely voluntary, if they would like to participate and if they choose to drink alcohol, we ask them to participate in the placebo controlled study in the safety of their own home. Then materials for the study are given out prior to their participation. An envelope is given with the questionnaire, and a small packet containing 3 pills of either NAC or placebo, and a small smear of Vicks vapor rub concealed in a small packet. At the end of their alcohol ingestion, the volunteer is asked to estimate the number roof drinks consumed and take 1 capsule per 3 drinks consumed of either 600 mg N-Acetyl-L-Cysteine or placebo capsules. In the morning, each participant fills out a Hangover Symptom Score questionnaire . A random number generator is used to determine placebo or NAC first, then the participant is given the other treatment at their subsequent encounter. Then study is being conducted over a series of many months, and data can be analyzed by the hangover symptoms scale data when using NAC compared to placebo. The data will be analyzed using the numerical values of each category for hangover classification and compare the placebo data to the control data.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: