N-acetylcysteine as an adjunctive treatment in treatment-resistant posttraumatic stress disorder: A randomised controlled trial
Background: Posttraumatic stress disorder (PTSD) is hard to treat effectively, as most patients who receive the standard treatments still have PTSD symptoms afterwards. Evidence exists that indicates that a drug called n-acetylcysteine (NAC), which supports the body’s anti-oxidants, can help to treat PTSD, as well as comorbid depression and addictions.
Aim: This study aims to investigate the efficacy of NAC as an adjunct to first line treatment in treatment-resistant PTSD in a sample of Australian veterans. The primary outcome measures will be the core PTSD symptoms, measured by the Clinician Administered PTSD Scale (CAPS). Secondary outcomes will include depressive symptoms, substance use, functioning, and quality of life.
Study Design: A 12-week, double blind, randomised, placebo-controlled trial of NAC, given as an adjunct to those who still have PTSD despite having received first line treatment. This study will be conducted at the Psychological Trauma Recovery Service at the Heidelberg Repatriation Hospital, Melbourne, a specialist PTSD treatment centre. We will recruit 126 participants (63 per arm). All will be over 18; have the capacity to consent; and fulfil the criteria for current PTSD. They will remain on standard pharmacotherapy during the study. The trial clinician will contact all those referred and screen for suitability through a face-to-face interview, confirming the diagnosis using the CAPS, and obtaining written informed consent. Individuals accepted into the trial will be randomly allocated in a double-blind fashion to receive either NAC or placebo, in addition to any established treatments for their PTSD. A fixed dose regime of 2.7g/day of NAC will be used. Measures will be completed at baseline, weeks 4, 8 and 12 of the trial, and 4 weeks after trial discontinuation. These measures include the CAPS, the Hospital Anxiety and Depression Scale, alcohol and substance use (AUDIT, Urine Drug Screen, Self-report craving).