Trial · NCT02966873

Clinical Trial for Alcohol Use Disorder and Post Traumatic Stress Disorder (PTSD)

NCT02966873, Phase 2, Completed, Medical University of South Carolina; results first posted 2023-04-18

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Clinical Trial for Alcohol Use Disorder and Post Traumatic Stress Disorder (PTSD). Trials, record NCT02966873. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02966873

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Clinical Trial for Alcohol Use Disorder and Post Traumatic Stress Disorder (PTSD)
NCT number: NCT02966873
Status: Completed
Phases: Phase 2
Enrollment: 182 participants, actual
Lead sponsor: Medical University of South Carolina
Conditions: Post Traumatic Stress Disorder (PTSD), Addiction, Alcohol Abuse
Interventions: N-Acetylcysteine (NAC) Treatment, Cognitive Behavioral Therapy (CBT), Inactive Placebo Oral Capsule, Functional magnetic resonance imaging (fMRI), Proton magnetic resonance spectroscopy (MRS) Imaging
First posted: 2016-11-17
Last updated: 2026-04-13
Results first posted: 2023-04-18

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Alcohol Use Severity	From baseline to week 12	Change in Alcohol Use Severity as measured by standard drinks per day using the Time Line Follow Back (TLFB) to measure alcohol consumption. Fewer standard drinks per day represent better outcomes. Greater change in standard drinks per day represents better outcomes.
Primary	Change in Alcohol Craving - Obsessive Subscale	From baseline to week 12	Change in Alcohol Craving as measured by the Obsessive Compulsive Drinking Scale (OCDS) to measure the obsessive subscale of alcohol craving. The OCDS is a 14-item questionnaire that measures alcohol use and attempts to control drinking. Obsessive subscale includes items 1-6. Each item is scored on a scale from 0 to 4. Scores range from 0 to 28, with lower scores representing better outcomes.
Primary	Change in Post Traumatic Stress Disorder Symptom Severity - Clinician Rated	From baseline to week 12	Change in Post Traumatic Stress Disorder symptom severity as measured by Clinician Administered PTSD Scale (CAPS-5) for clinician-rated posttraumatic stress symptoms. The CAPS-5 is a 30-item structured interview. CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 PTSD symptoms, each with severity scores ranging from 0-4. The overall total severity score for CAPS-5 ranges from 0-80, with lower scores representing better outcomes (less severe PTSD).
Primary	Change in Post Traumatic Stress Disorder Symptom Severity - Self Report	From baseline to week 12	Change in Post Traumatic Stress Disorder (PTSD) symptom severity as measured by the Posttraumatic Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition \[DSM-5\](PCL-5) for self-reported symptoms. The PCL-5 is a 20-item self-report measure that assesses the 20 symptoms of PTSD. The rating scale is 0-4 for each symptom/item, and overall scores range from 0-80, with lower scores representing better outcomes (less severe PTSD).
Primary	Change in Alcohol Craving - Compulsive Subscale	From baseline to week 12	Change in Alcohol Craving as measured by the Obsessive Compulsive Drinking Scale (OCDS) to measure the compulsive subscale of alcohol craving. The OCDS is a 14-item questionnaire that measures alcohol use and attempts to control drinking. Compulsive subscale includes items 7-14. Each item is scored on a scale from 0 to 4. Scores range from 0 to 32, with lower scores representing better outcomes.
Primary	Change in Alcohol Use Severity - Percent Days Abstinent	From baseline to week 12	Change in Alcohol Use Severity as measured by the percent days abstinent using the Time Line Follow Back (TLFB) to measure alcohol consumption. Greater percentage of days of abstinence represents better outcomes. Greater change in Percent Days Abstinent represents better outcomes.

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Change in Alcohol Use Severity	From baseline to week 12	standard drinks per day	MEAN
PRIMARY	Change in Alcohol Craving - Obsessive Subscale	From baseline to week 12	units on a scale	MEAN
PRIMARY	Change in Post Traumatic Stress Disorder Symptom Severity - Clinician Rated	From baseline to week 12	units on a scale	MEAN
PRIMARY	Change in Post Traumatic Stress Disorder Symptom Severity - Self Report	From baseline to week 12	units on a scale	MEAN
PRIMARY	Change in Alcohol Craving - Compulsive Subscale	From baseline to week 12	units on a scale	MEAN
PRIMARY	Change in Alcohol Use Severity - Percent Days Abstinent	From baseline to week 12	percentage of days abstinent for alcohol	MEAN

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change in Alcohol Use Severity	N-Acetylcysteine (NAC) Treatment Group	-3.406	Standard Deviation 3.738	standard drinks per day
Change in Alcohol Use Severity	Placebo Group	-3.934	Standard Deviation .825	standard drinks per day
Change in Alcohol Craving - Obsessive Subscale	N-Acetylcysteine (NAC) Treatment Group	-2.597	Standard Deviation 4.314	units on a scale
Change in Alcohol Craving - Obsessive Subscale	Placebo Group	-2.521	Standard Deviation 3.738	units on a scale
Change in Post Traumatic Stress Disorder Symptom Severity - Clinician Rated	N-Acetylcysteine (NAC) Treatment Group	-11.838	Standard Deviation 9.834	units on a scale
Change in Post Traumatic Stress Disorder Symptom Severity - Clinician Rated	Placebo Group	-13.863	Standard Deviation 10.87	units on a scale
Change in Post Traumatic Stress Disorder Symptom Severity - Self Report	N-Acetylcysteine (NAC) Treatment Group	-15.997	Standard Deviation 18.907	units on a scale
Change in Post Traumatic Stress Disorder Symptom Severity - Self Report	Placebo Group	-18.129	Standard Deviation 18.37	units on a scale
Change in Alcohol Craving - Compulsive Subscale	N-Acetylcysteine (NAC) Treatment Group	-4.584	Standard Deviation 3.971	units on a scale
Change in Alcohol Craving - Compulsive Subscale	Placebo Group	-4.905	Standard Deviation 4.266	units on a scale

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	N-Acetylcysteine (NAC) Treatment Group	93
Overall Study	STARTED	Placebo Group	89
Overall Study	COMPLETED	N-Acetylcysteine (NAC) Treatment Group	77
Overall Study	COMPLETED	Placebo Group	74
Overall Study	NOT COMPLETED	N-Acetylcysteine (NAC) Treatment Group	16
Overall Study	NOT COMPLETED	Placebo Group	15

Source ClinicalTrials.gov

Adverse events36

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anxiety	Nervous system disorders	N-Acetylcysteine (NAC) Treatment Group	2	93	4
other	Anxiety	Nervous system disorders	Placebo Group	7	89	11
other	Constipation	Gastrointestinal disorders	N-Acetylcysteine (NAC) Treatment Group	2	93	2
other	Constipation	Gastrointestinal disorders	Placebo Group	4	89	5
other	Gastrointestinal Discomfort	Gastrointestinal disorders	N-Acetylcysteine (NAC) Treatment Group	21	93	23
other	Gastrointestinal Discomfort	Gastrointestinal disorders	Placebo Group	9	89	11
other	Headache/Migraine	Nervous system disorders	N-Acetylcysteine (NAC) Treatment Group	4	93	4
other	Headache/Migraine	Nervous system disorders	Placebo Group	13	89	14
other	Injury	Injury, poisoning and procedural complications	N-Acetylcysteine (NAC) Treatment Group	9	93	12
other	Injury	Injury, poisoning and procedural complications	Placebo Group	8	89	9

1 to 10 of 36Source ClinicalTrials.gov

See all 36 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	N-Acetylcysteine (NAC) Treatment Group	0	93
Total, all-cause mortality	Placebo Group	1	89
Total, other adverse events	N-Acetylcysteine (NAC) Treatment Group	39	93
Total, other adverse events	Placebo Group	39	89
Total, serious adverse events	N-Acetylcysteine (NAC) Treatment Group	5	93
Total, serious adverse events	Placebo Group	3	89

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
40875537	DERIVED

Source PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01AA025086	A Randomized Controlled Trial of N-Acetylcysteine for Alcohol Use Disorder and Comorbid PTSD	BACK, SUDIE E; GRAY, KEVIN M; SANTA ANA, ELIZABETH J	MEDICAL UNIVERSITY OF SOUTH CAROLINA	NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM	2016 to 2020

Source NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
N-Acetylcysteine (NAC) Treatment Group vs Placebo Group: deaths from any cause	Trial comparisons
N-Acetylcysteine (NAC) Treatment Group vs Placebo Group: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02966873

GET https://conductscience.org/api/trials/v1/NCT02966873/events?page=2

API reference For AI assistants