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Antioxidant

N-Acetylcysteine for Alcohol Consumption

Phase 2
Waitlist Available
Led By Lindsay M Squeglia, PhD
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Please call the site for additional information
Inclusion criteria: Participants were between the ages of 15-19 and may or may not have used alcohol. All participants in the alcohol-using group met criteria for heavy drinking, based on quantity and frequency of drinking (Squeglia et al. 2011; Squeglia et al. 2012) (see Figure 2).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 31 days total (levels compared to baseline after 10 days on n-acetylcysteine and placebo with 11 day washout period in between)
Awards & highlights

Study Summary

This trial will study the effects of N-Acetylcysteine, an antioxidant supplement, on the brains of adolescents using MRI. 55 participants will receive NAC or a placebo for 10 days, with a 11 day break in between, and have MRI scans at the beginning and end of each trial.

Eligible Conditions
  • Controlled
  • Alcohol Consumption

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~31 days total (levels compared after 10 days on n-acetylcysteine and 10-days of placebo with 11 day washout period in between)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 31 days total (levels compared after 10 days on n-acetylcysteine and 10-days of placebo with 11 day washout period in between) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Neural Reactivity (as Measured by BOLD: Blood Oxygen Level-Dependent Response) in Reward Regions During Alcohol-cue Reactivity Task.
Quantifying the Difference in Glutamate Levels (mmol/kg) During N-Acetylcysteine Versus Placebo in the Anterior Cingulate Brain Region.
Secondary outcome measures
Change in neural reactivity (as measured by BOLD: Blood Oxygen Level-Dependent response) in reward regions during alcohol-cue reactivity task.

Side effects data

From 2015 Phase 3 trial • 302 Patients • NCT01675661
7%
Headache
5%
Nausea
5%
Diarrhea
2%
Abdominal discomfort
2%
Dyspepsia
2%
Pruritis
1%
Alcohol abuse
1%
Road traffic accident
1%
Cellulitis
1%
Arthropod bite
1%
Gastrointestinal disorder
1%
Abdominal pain
1%
Vomiting
1%
Reflux disease
1%
Dizziness
1%
Insomnia
1%
Rash
1%
Energy increased
1%
Groin Abscess
1%
Flushing
1%
Fatigue
1%
Panic attack
1%
Depression
1%
Blood pressure increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
NAC Plus CM
Placebo Plus CM

Trial Design

2Treatment groups
Experimental Treatment
Group I: Placebo, then N-AcetylcysteineExperimental Treatment2 Interventions
Participants first received placebo capsules mimicking N-Acetylcysteine (two pills, twice daily) will be taken for 10 days. After washout for 11 days, they then received N-Acetylcysteine 600mg capsules by mouth, two pills twice daily will be taken for 10 days.
Group II: N-Acetylcysteine, then PlaceboExperimental Treatment2 Interventions
Participants first received N-Acetylcysteine 600mg capsules by mouth, two pills twice daily will be taken for 10 days. After washout for 11 days, they then received placebo capsules mimicking N-Acetylcysteine (two pills, twice daily) will be taken for 10 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo Oral Capsule
2016
Completed Phase 4
~1680
Acetylcysteine
FDA approved

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor
929 Previous Clinical Trials
7,393,760 Total Patients Enrolled
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
791 Previous Clinical Trials
1,356,927 Total Patients Enrolled
Lindsay M Squeglia, PhDPrincipal InvestigatorMedical University of South Carolina
1 Previous Clinical Trials
41 Total Patients Enrolled

Frequently Asked Questions

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~8 spots leftby Mar 2025