Phase 2 N=35 Randomized Quadruple-blind Treatment

N-acetylcysteine in the Treatment of PTSD and Addiction

PTSD · Addiction

Bottom Line

View on ClinicalTrials.gov: NCT02499029 ↗

Enrolled (actual)

Serious AEs

11.4%

Results posted

Aug 2018

Primary outcome: Primary: PTSD Symptoms — 38.7; 52.8; 32.0; 51.5 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: N-acetylcysteine (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Medical University of South Carolina
Primary completion: Sep 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY PTSD Symptoms	33.8; 41.9; 31.2; 41.9	.05
SECONDARY Depression	10.9; 18.5; 9.9; 19.3	—
SECONDARY Craving	1.8; 2.8; .7; 2.8; 1.8; 2.4	—
SECONDARY PTSD Symptoms	33.8; 41.9; 31.2; 41.9	.05

Summary

Examine the effects of N-acetylcysteine on PTSD symptoms, craving and substance use in veterans with PTSD and comorbid substance use disorders.

Eligibility Criteria

Inclusion Criteria

18-65 year old
U.S. military Veteran, Reservist, or National Guard member
DSM-IV diagnostic criteria for current (past 6 months) SUD and PTSD or subthreshold PTSD (i.e., met criteria for cluster B (re-experiencing) and either cluster C (avoidance) or D (hyperarousal), as well as duration of one month and clinically significant impairment)
Score of > 21 on the Mini-Mental State Exam (MMSE).

Exclusion Criteria

Unstable medical conditions
Bipolar or psychotic disorders
Seizures or asthma
Prior treatment with NAC
Suicidality
Enrolled in ongoing PTSD treatment (pharmacotherapy or psychosocial)
Females: could not be pregnant or lactating

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02499029). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.