Trial Outcomes & Findings for Neuroscience-Informed Treatment Development for Adolescent Alcohol Use (NCT NCT03238300)

Last Updated: 2023-06-22

Results Overview

Using magnetic resonance spectroscopy and a within-subjects design, we will determine the effect of N-Acetylcysteine versus placebo on modulating anterior cingulate glutamate levels in adolescents. Values provided are absolute values (mmol/kg) at the end of each intervention period. Due to complexities of this method, "normal" levels of glutamate are not known; thus, we cannot make conclusions about the meaning of "higher" or "lower" glutamate levels when comparing N-acetylcysteine to placebo.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

57 participants

Primary outcome timeframe

31 days total (levels compared after 10 days on N-Acetylcysteine and 10-days of placebo with 11 day washout period in between)

Results posted on

2023-06-22

Participant Flow

57 participants were screened for eligibility between October 16, 2017 and February 18, 2022 at the Medical University of South Carolina.

35 of 57 were randomized. Of those not randomized, 12 were ineligible, 6 declined to participate, and 4 withdrew or were withdrawn during the baseline visit.

Participant milestones

Participant milestones
Measure	N-Acetylcysteine, Then Placebo N-Acetylcysteine 600mg capsules by mouth, two pills twice daily will be taken for 10 days. After washout for 11 days, placebo capsules mimicking N-Acetylcysteine (two pills, twice daily) will be taken for 10 days.	Placebo, Then N-Acetylcysteine Placebo capsules mimicking N-Acetylcysteine (two pills, twice daily) will be taken for 10 days. After washout for 11 days, N-Acetylcysteine 600mg capsules by mouth, two pills twice daily will be taken for 10 days
Baseline (Before Intervention) STARTED	18	17
Baseline (Before Intervention) COMPLETED	18	16
Baseline (Before Intervention) NOT COMPLETED	0	1
First Intervention (10-Days) STARTED	18	16
First Intervention (10-Days) COMPLETED	18	16
First Intervention (10-Days) NOT COMPLETED	0	0
Washout Period (11-Days) STARTED	18	16
Washout Period (11-Days) COMPLETED	17	16
Washout Period (11-Days) NOT COMPLETED	1	0
Second Intervention (10-Days) STARTED	17	16
Second Intervention (10-Days) COMPLETED	15	16
Second Intervention (10-Days) NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	N-Acetylcysteine, Then Placebo N-Acetylcysteine 600mg capsules by mouth, two pills twice daily will be taken for 10 days. After washout for 11 days, placebo capsules mimicking N-Acetylcysteine (two pills, twice daily) will be taken for 10 days.	Placebo, Then N-Acetylcysteine Placebo capsules mimicking N-Acetylcysteine (two pills, twice daily) will be taken for 10 days. After washout for 11 days, N-Acetylcysteine 600mg capsules by mouth, two pills twice daily will be taken for 10 days
Baseline (Before Intervention) Physician Decision	0	1
Washout Period (11-Days) Withdrawal by Subject	1	0
Second Intervention (10-Days) Lost to Follow-up	1	0
Second Intervention (10-Days) Withdrawal by Subject	1	0

Baseline Characteristics

Neuroscience-Informed Treatment Development for Adolescent Alcohol Use

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	N-Acetylcysteine, Then Placebo n=18 Participants N-Acetylcysteine 600mg capsules by mouth, two pills twice daily will be taken for 10 days. After washout for 11 days, placebo capsules mimicking N-Acetylcysteine (two pills, twice daily) will be taken for 10 days.	Placebo, Then N-Acetylcysteine n=17 Participants Placebo capsules mimicking N-Acetylcysteine (two pills, twice daily) will be taken for 10 days. After washout for 11 days, N-Acetylcysteine 600mg capsules by mouth, two pills twice daily will be taken for 10 days	Total n=35 Participants Total of all reporting groups
Age, Continuous	18.90 Years STANDARD_DEVIATION 0.75 • n=5 Participants	18.79 Years STANDARD_DEVIATION 0.60 • n=7 Participants	18.85 Years STANDARD_DEVIATION 0.67 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	6 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants	15 Participants n=7 Participants	33 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	18 Participants n=5 Participants	17 Participants n=7 Participants	35 Participants n=5 Participants

PRIMARY outcome

Timeframe: 31 days total (levels compared after 10 days on N-Acetylcysteine and 10-days of placebo with 11 day washout period in between)

Outcome measures

Outcome measures
Measure	N-Acetylcysteine n=31 Participants N-Acetylcysteine 600mg capsules by mouth, two pills twice daily will be taken for 10 days	Placebo n=31 Participants Placebo capsules mimicking N-Acetylcysteine (two pills, twice daily) will be taken for 10 days
Quantifying the Difference in Glutamate Levels (mmol/kg) During N-Acetylcysteine Versus Placebo in the Anterior Cingulate Brain Region.	15.7527667 mmol/kg Standard Deviation 0.748460934	15.6265229 mmol/kg Standard Deviation 0.778392692

PRIMARY outcome

Timeframe: 31 days total (levels compared after 10 days on N-Acetylcysteine and 10-days of placebo with 11 day washout period in between)

Assessing the change in neural reactivity to alcohol cues after each round of medication: Placebo vs. N-Acetylcysteine. Cue reactivity is a type of learned response which is observed in individuals who use substances (e.g., alcohol) and involves significant physiological reactions to presentations of substance-related stimuli (i.e., alcohol images) in comparison to neutral images (e.g., non-alcoholic beverages ) measured by BOLD (Blood Oxygen Level-Dependent response). ROIs were (left and right hemisphere): amygdala, caudate, insula, nucleus accumbens, and putamen. Change in BOLD signal are reported in Z-scores. A Z-score of 0 would indicate there is no statistical difference in BOLD signal between alcohol images and non-alcohol beverage images. A higher Z-score would indicated a higher BOLD signal during alcohol images compared to non-alcohol beverage images. A lower Z-score would indicate a lower BOLD signal during alcohol images compared to non-alcohol beverage images.

Outcome measures

Outcome measures
Measure	N-Acetylcysteine n=31 Participants N-Acetylcysteine 600mg capsules by mouth, two pills twice daily will be taken for 10 days	Placebo n=31 Participants Placebo capsules mimicking N-Acetylcysteine (two pills, twice daily) will be taken for 10 days
Change in Neural Reactivity (as Measured by BOLD: Blood Oxygen Level-Dependent Response) in Reward Regions During Alcohol-cue Reactivity Task. Left Amygdala	0.649576194 Z-score Standard Deviation 0.968974541	0.3018234193548 Z-score Standard Deviation 0.841575583
Change in Neural Reactivity (as Measured by BOLD: Blood Oxygen Level-Dependent Response) in Reward Regions During Alcohol-cue Reactivity Task. Right Amygdala	0.56294871 Z-score Standard Deviation 0.999382512	0.210653871 Z-score Standard Deviation 0.946731462
Change in Neural Reactivity (as Measured by BOLD: Blood Oxygen Level-Dependent Response) in Reward Regions During Alcohol-cue Reactivity Task. Right Caudate	0.065642839 Z-score Standard Deviation 1.100274051	0.031422161 Z-score Standard Deviation 0.79443319
Change in Neural Reactivity (as Measured by BOLD: Blood Oxygen Level-Dependent Response) in Reward Regions During Alcohol-cue Reactivity Task. Left Insula	-0.258198161 Z-score Standard Deviation 1.142477966	0.058738871 Z-score Standard Deviation 0.846769387
Change in Neural Reactivity (as Measured by BOLD: Blood Oxygen Level-Dependent Response) in Reward Regions During Alcohol-cue Reactivity Task. Right Insula	-0.429143032 Z-score Standard Deviation 1.2071406050607	-0.169528194 Z-score Standard Deviation 1.075103119
Change in Neural Reactivity (as Measured by BOLD: Blood Oxygen Level-Dependent Response) in Reward Regions During Alcohol-cue Reactivity Task. Left Nucleus Accumbens	0.347468645 Z-score Standard Deviation 1.0725798	0.2095879354838 Z-score Standard Deviation 0.697815244
Change in Neural Reactivity (as Measured by BOLD: Blood Oxygen Level-Dependent Response) in Reward Regions During Alcohol-cue Reactivity Task. Right Nucleus Accumbens	0.240204258 Z-score Standard Deviation 1.151021574	0.072915871 Z-score Standard Deviation 0.9231385308441
Change in Neural Reactivity (as Measured by BOLD: Blood Oxygen Level-Dependent Response) in Reward Regions During Alcohol-cue Reactivity Task. Left Putamen	-0.138118065 Z-score Standard Deviation 0.894080737	0.225092871 Z-score Standard Deviation 0.989678164
Change in Neural Reactivity (as Measured by BOLD: Blood Oxygen Level-Dependent Response) in Reward Regions During Alcohol-cue Reactivity Task. Right Putamen	-0.165481516 Z-score Standard Deviation 0.818905961	0.058414516 Z-score Standard Deviation 0.9453397543003
Change in Neural Reactivity (as Measured by BOLD: Blood Oxygen Level-Dependent Response) in Reward Regions During Alcohol-cue Reactivity Task. Left Caudate	0.137316806 Z-score Standard Deviation 0.970053483	0.110683871 Z-score Standard Deviation 0.826040069

Adverse Events

N-Acetylcysteine

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Placebo Oral Capsule

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Washout Period

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Baseline

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	N-Acetylcysteine n=34 participants at risk N-Acetylcysteine 600mg capsules by mouth, two pills twice daily for 10 days. N-Acetylcysteine: N-Acetylcysteine pill.	Placebo Oral Capsule n=34 participants at risk Placebo capsules by mouth, two pills twice daily for 10 days. Placebo Oral Capsule: Sugar pill to mimic.	Washout Period n=33 participants at risk 11-days with no medication, but check in with study staff and assessment of AEs	Baseline n=35 participants at risk Prior to first intervention
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorder	2.9% 1/34 • Number of events 1 • 31 days (10 days of first intervention, 11-day wash out, 10 days of second intervention) Intervention = N-acetylcysteine, then Placebo OR Placebo, then N-acetylcysteine Participants were asked about adverse events at every visit, either from a research assistant, principal investigator, medical clinician, or other study staff.	0.00% 0/34 • 31 days (10 days of first intervention, 11-day wash out, 10 days of second intervention) Intervention = N-acetylcysteine, then Placebo OR Placebo, then N-acetylcysteine Participants were asked about adverse events at every visit, either from a research assistant, principal investigator, medical clinician, or other study staff.	0.00% 0/33 • 31 days (10 days of first intervention, 11-day wash out, 10 days of second intervention) Intervention = N-acetylcysteine, then Placebo OR Placebo, then N-acetylcysteine Participants were asked about adverse events at every visit, either from a research assistant, principal investigator, medical clinician, or other study staff.	0.00% 0/35 • 31 days (10 days of first intervention, 11-day wash out, 10 days of second intervention) Intervention = N-acetylcysteine, then Placebo OR Placebo, then N-acetylcysteine Participants were asked about adverse events at every visit, either from a research assistant, principal investigator, medical clinician, or other study staff.
General disorders Fatigue	0.00% 0/34 • 31 days (10 days of first intervention, 11-day wash out, 10 days of second intervention) Intervention = N-acetylcysteine, then Placebo OR Placebo, then N-acetylcysteine Participants were asked about adverse events at every visit, either from a research assistant, principal investigator, medical clinician, or other study staff.	2.9% 1/34 • Number of events 1 • 31 days (10 days of first intervention, 11-day wash out, 10 days of second intervention) Intervention = N-acetylcysteine, then Placebo OR Placebo, then N-acetylcysteine Participants were asked about adverse events at every visit, either from a research assistant, principal investigator, medical clinician, or other study staff.	0.00% 0/33 • 31 days (10 days of first intervention, 11-day wash out, 10 days of second intervention) Intervention = N-acetylcysteine, then Placebo OR Placebo, then N-acetylcysteine Participants were asked about adverse events at every visit, either from a research assistant, principal investigator, medical clinician, or other study staff.	0.00% 0/35 • 31 days (10 days of first intervention, 11-day wash out, 10 days of second intervention) Intervention = N-acetylcysteine, then Placebo OR Placebo, then N-acetylcysteine Participants were asked about adverse events at every visit, either from a research assistant, principal investigator, medical clinician, or other study staff.
Nervous system disorders Headache	2.9% 1/34 • Number of events 1 • 31 days (10 days of first intervention, 11-day wash out, 10 days of second intervention) Intervention = N-acetylcysteine, then Placebo OR Placebo, then N-acetylcysteine Participants were asked about adverse events at every visit, either from a research assistant, principal investigator, medical clinician, or other study staff.	5.9% 2/34 • Number of events 2 • 31 days (10 days of first intervention, 11-day wash out, 10 days of second intervention) Intervention = N-acetylcysteine, then Placebo OR Placebo, then N-acetylcysteine Participants were asked about adverse events at every visit, either from a research assistant, principal investigator, medical clinician, or other study staff.	0.00% 0/33 • 31 days (10 days of first intervention, 11-day wash out, 10 days of second intervention) Intervention = N-acetylcysteine, then Placebo OR Placebo, then N-acetylcysteine Participants were asked about adverse events at every visit, either from a research assistant, principal investigator, medical clinician, or other study staff.	0.00% 0/35 • 31 days (10 days of first intervention, 11-day wash out, 10 days of second intervention) Intervention = N-acetylcysteine, then Placebo OR Placebo, then N-acetylcysteine Participants were asked about adverse events at every visit, either from a research assistant, principal investigator, medical clinician, or other study staff.
Gastrointestinal disorders Vomiting	0.00% 0/34 • 31 days (10 days of first intervention, 11-day wash out, 10 days of second intervention) Intervention = N-acetylcysteine, then Placebo OR Placebo, then N-acetylcysteine Participants were asked about adverse events at every visit, either from a research assistant, principal investigator, medical clinician, or other study staff.	2.9% 1/34 • Number of events 1 • 31 days (10 days of first intervention, 11-day wash out, 10 days of second intervention) Intervention = N-acetylcysteine, then Placebo OR Placebo, then N-acetylcysteine Participants were asked about adverse events at every visit, either from a research assistant, principal investigator, medical clinician, or other study staff.	0.00% 0/33 • 31 days (10 days of first intervention, 11-day wash out, 10 days of second intervention) Intervention = N-acetylcysteine, then Placebo OR Placebo, then N-acetylcysteine Participants were asked about adverse events at every visit, either from a research assistant, principal investigator, medical clinician, or other study staff.	0.00% 0/35 • 31 days (10 days of first intervention, 11-day wash out, 10 days of second intervention) Intervention = N-acetylcysteine, then Placebo OR Placebo, then N-acetylcysteine Participants were asked about adverse events at every visit, either from a research assistant, principal investigator, medical clinician, or other study staff.
Eye disorders Conjunctivitis	0.00% 0/34 • 31 days (10 days of first intervention, 11-day wash out, 10 days of second intervention) Intervention = N-acetylcysteine, then Placebo OR Placebo, then N-acetylcysteine Participants were asked about adverse events at every visit, either from a research assistant, principal investigator, medical clinician, or other study staff.	2.9% 1/34 • Number of events 1 • 31 days (10 days of first intervention, 11-day wash out, 10 days of second intervention) Intervention = N-acetylcysteine, then Placebo OR Placebo, then N-acetylcysteine Participants were asked about adverse events at every visit, either from a research assistant, principal investigator, medical clinician, or other study staff.	0.00% 0/33 • 31 days (10 days of first intervention, 11-day wash out, 10 days of second intervention) Intervention = N-acetylcysteine, then Placebo OR Placebo, then N-acetylcysteine Participants were asked about adverse events at every visit, either from a research assistant, principal investigator, medical clinician, or other study staff.	0.00% 0/35 • 31 days (10 days of first intervention, 11-day wash out, 10 days of second intervention) Intervention = N-acetylcysteine, then Placebo OR Placebo, then N-acetylcysteine Participants were asked about adverse events at every visit, either from a research assistant, principal investigator, medical clinician, or other study staff.
Gastrointestinal disorders Nausea	11.8% 4/34 • Number of events 4 • 31 days (10 days of first intervention, 11-day wash out, 10 days of second intervention) Intervention = N-acetylcysteine, then Placebo OR Placebo, then N-acetylcysteine Participants were asked about adverse events at every visit, either from a research assistant, principal investigator, medical clinician, or other study staff.	0.00% 0/34 • 31 days (10 days of first intervention, 11-day wash out, 10 days of second intervention) Intervention = N-acetylcysteine, then Placebo OR Placebo, then N-acetylcysteine Participants were asked about adverse events at every visit, either from a research assistant, principal investigator, medical clinician, or other study staff.	0.00% 0/33 • 31 days (10 days of first intervention, 11-day wash out, 10 days of second intervention) Intervention = N-acetylcysteine, then Placebo OR Placebo, then N-acetylcysteine Participants were asked about adverse events at every visit, either from a research assistant, principal investigator, medical clinician, or other study staff.	0.00% 0/35 • 31 days (10 days of first intervention, 11-day wash out, 10 days of second intervention) Intervention = N-acetylcysteine, then Placebo OR Placebo, then N-acetylcysteine Participants were asked about adverse events at every visit, either from a research assistant, principal investigator, medical clinician, or other study staff.
Gastrointestinal disorders Stomachache	8.8% 3/34 • Number of events 3 • 31 days (10 days of first intervention, 11-day wash out, 10 days of second intervention) Intervention = N-acetylcysteine, then Placebo OR Placebo, then N-acetylcysteine Participants were asked about adverse events at every visit, either from a research assistant, principal investigator, medical clinician, or other study staff.	0.00% 0/34 • 31 days (10 days of first intervention, 11-day wash out, 10 days of second intervention) Intervention = N-acetylcysteine, then Placebo OR Placebo, then N-acetylcysteine Participants were asked about adverse events at every visit, either from a research assistant, principal investigator, medical clinician, or other study staff.	0.00% 0/33 • 31 days (10 days of first intervention, 11-day wash out, 10 days of second intervention) Intervention = N-acetylcysteine, then Placebo OR Placebo, then N-acetylcysteine Participants were asked about adverse events at every visit, either from a research assistant, principal investigator, medical clinician, or other study staff.	0.00% 0/35 • 31 days (10 days of first intervention, 11-day wash out, 10 days of second intervention) Intervention = N-acetylcysteine, then Placebo OR Placebo, then N-acetylcysteine Participants were asked about adverse events at every visit, either from a research assistant, principal investigator, medical clinician, or other study staff.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	2.9% 1/34 • Number of events 1 • 31 days (10 days of first intervention, 11-day wash out, 10 days of second intervention) Intervention = N-acetylcysteine, then Placebo OR Placebo, then N-acetylcysteine Participants were asked about adverse events at every visit, either from a research assistant, principal investigator, medical clinician, or other study staff.	0.00% 0/34 • 31 days (10 days of first intervention, 11-day wash out, 10 days of second intervention) Intervention = N-acetylcysteine, then Placebo OR Placebo, then N-acetylcysteine Participants were asked about adverse events at every visit, either from a research assistant, principal investigator, medical clinician, or other study staff.	0.00% 0/33 • 31 days (10 days of first intervention, 11-day wash out, 10 days of second intervention) Intervention = N-acetylcysteine, then Placebo OR Placebo, then N-acetylcysteine Participants were asked about adverse events at every visit, either from a research assistant, principal investigator, medical clinician, or other study staff.	0.00% 0/35 • 31 days (10 days of first intervention, 11-day wash out, 10 days of second intervention) Intervention = N-acetylcysteine, then Placebo OR Placebo, then N-acetylcysteine Participants were asked about adverse events at every visit, either from a research assistant, principal investigator, medical clinician, or other study staff.
Respiratory, thoracic and mediastinal disorders Sore Throat	0.00% 0/34 • 31 days (10 days of first intervention, 11-day wash out, 10 days of second intervention) Intervention = N-acetylcysteine, then Placebo OR Placebo, then N-acetylcysteine Participants were asked about adverse events at every visit, either from a research assistant, principal investigator, medical clinician, or other study staff.	0.00% 0/34 • 31 days (10 days of first intervention, 11-day wash out, 10 days of second intervention) Intervention = N-acetylcysteine, then Placebo OR Placebo, then N-acetylcysteine Participants were asked about adverse events at every visit, either from a research assistant, principal investigator, medical clinician, or other study staff.	3.0% 1/33 • Number of events 1 • 31 days (10 days of first intervention, 11-day wash out, 10 days of second intervention) Intervention = N-acetylcysteine, then Placebo OR Placebo, then N-acetylcysteine Participants were asked about adverse events at every visit, either from a research assistant, principal investigator, medical clinician, or other study staff.	0.00% 0/35 • 31 days (10 days of first intervention, 11-day wash out, 10 days of second intervention) Intervention = N-acetylcysteine, then Placebo OR Placebo, then N-acetylcysteine Participants were asked about adverse events at every visit, either from a research assistant, principal investigator, medical clinician, or other study staff.
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/34 • 31 days (10 days of first intervention, 11-day wash out, 10 days of second intervention) Intervention = N-acetylcysteine, then Placebo OR Placebo, then N-acetylcysteine Participants were asked about adverse events at every visit, either from a research assistant, principal investigator, medical clinician, or other study staff.	0.00% 0/34 • 31 days (10 days of first intervention, 11-day wash out, 10 days of second intervention) Intervention = N-acetylcysteine, then Placebo OR Placebo, then N-acetylcysteine Participants were asked about adverse events at every visit, either from a research assistant, principal investigator, medical clinician, or other study staff.	0.00% 0/33 • 31 days (10 days of first intervention, 11-day wash out, 10 days of second intervention) Intervention = N-acetylcysteine, then Placebo OR Placebo, then N-acetylcysteine Participants were asked about adverse events at every visit, either from a research assistant, principal investigator, medical clinician, or other study staff.	2.9% 1/35 • Number of events 1 • 31 days (10 days of first intervention, 11-day wash out, 10 days of second intervention) Intervention = N-acetylcysteine, then Placebo OR Placebo, then N-acetylcysteine Participants were asked about adverse events at every visit, either from a research assistant, principal investigator, medical clinician, or other study staff.
Respiratory, thoracic and mediastinal disorders Viral Upper Respiratory Tract Infection	0.00% 0/34 • 31 days (10 days of first intervention, 11-day wash out, 10 days of second intervention) Intervention = N-acetylcysteine, then Placebo OR Placebo, then N-acetylcysteine Participants were asked about adverse events at every visit, either from a research assistant, principal investigator, medical clinician, or other study staff.	0.00% 0/34 • 31 days (10 days of first intervention, 11-day wash out, 10 days of second intervention) Intervention = N-acetylcysteine, then Placebo OR Placebo, then N-acetylcysteine Participants were asked about adverse events at every visit, either from a research assistant, principal investigator, medical clinician, or other study staff.	0.00% 0/33 • 31 days (10 days of first intervention, 11-day wash out, 10 days of second intervention) Intervention = N-acetylcysteine, then Placebo OR Placebo, then N-acetylcysteine Participants were asked about adverse events at every visit, either from a research assistant, principal investigator, medical clinician, or other study staff.	2.9% 1/35 • Number of events 1 • 31 days (10 days of first intervention, 11-day wash out, 10 days of second intervention) Intervention = N-acetylcysteine, then Placebo OR Placebo, then N-acetylcysteine Participants were asked about adverse events at every visit, either from a research assistant, principal investigator, medical clinician, or other study staff.

Additional Information

Lindsay M. Squeglia, PhD

Medical University of South Carolina

Phone: 843-792-5451

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place