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Mucolytic Agent
N-Acetylcysteine (NAC) Treatment for Post-Traumatic Stress Disorder
Phase 2
Waitlist Available
Led By Sudie Back, 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to week 12
Awards & highlights
Study Summary
This study is evaluating whether NAC may help reduce alcohol use and PTSD symptoms.
Eligible Conditions
- Post-Traumatic Stress Disorder
- Addiction
- Alcoholism
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline to week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to week 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Alcohol Craving - Compulsive Subscale
Change in Alcohol Craving - Obsessive Subscale
Change in Alcohol Use Severity
+3 moreSide effects data
From 2022 Phase 2 trial • 182 Patients • NCT0296687319%
Gastrointestinal Discomfort
16%
Viral Upper Respiratory Tract Infections (Cold)
10%
Nausea
10%
Injury
9%
Muscle or Joint Pain
5%
Flatulence
4%
Headache/Migraine
3%
Sinusitis
2%
Pneumonia
2%
Anxiety
2%
Constipation
1%
Stroke
1%
Sepsis
1%
Pancreatitis
1%
Bladder Infection
1%
Injury/Accident
100%
80%
60%
40%
20%
0%
Study treatment Arm
N-Acetylcysteine (NAC) Treatment Group
Placebo Group
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: N-Acetylcysteine (NAC) Treatment GroupExperimental Treatment4 Interventions
Participant will receive 12 weeks of Active Treatment NAC (2400 mg) daily, as well as weekly cognitive-behavioral therapy, medication management, and Adverse Event (AE) monitoring.
Participant will receive one week of study medication at a time from the study physician or the study coordinator. The study medication provided in blister packs in the form of 600 mg tablets. Each participant will be asked to take two (2) 600 mg tablets in the morning and two (2) 600 mg tablets in the evening.
Group II: Placebo GroupPlacebo Group4 Interventions
Participant will receive 12 weeks of inactive placebo comparator daily, as well as weekly cognitive-behavioral therapy, medication management, and Adverse Event (AE) monitoring.
Participant will receive one week of study medication (placebo) at a time from the study physician or the study coordinator. The study medication (placebo) provided in blister packs in the form of 600 mg tablets. Each participant will be asked to take two (2) 600 mg tablets in the morning and two (2) 600 mg tablets in the evening.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
N-Acetylcysteine (NAC) Treatment
2016
Completed Phase 2
~190
Cognitive Behavioral Therapy (CBT)
2008
Completed Phase 4
~3620
Find a Location
Who is running the clinical trial?
National Institutes of Health (NIH)NIH
2,701 Previous Clinical Trials
7,506,668 Total Patients Enrolled
Medical University of South CarolinaLead Sponsor
933 Previous Clinical Trials
7,394,454 Total Patients Enrolled
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
802 Previous Clinical Trials
1,365,263 Total Patients Enrolled
Frequently Asked Questions
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