NAC for Treating Comorbid PTSD and SUD

Completed · Phase 2 · Has a placebo group

Conditions studied: Posttraumatic Stress Disorder (PTSD), Alcohol Use Disorder (AUD), Substance Use Disorder (SUD)

In brief

As a result of sustained operations in Afghanistan and Iraq, there are an increasing number of U.S. military Veterans with substance use disorders and comorbid posttraumatic stress disorder (PTSD). If left untreated, individuals with substance use disorders and PTSD are at increased risk for developing other mental health problems (e.g., depression, anxiety), suicidal ideation and attempts, medical problems, reduced resiliency and military readiness, vocational problems, and family/social impairment. This study will determine the benefits of N-acetylcysteine (NAC) in treating alcohol use disorder and comorbid post-traumatic stress disorder (PTSD) among military Veterans.

Key facts

Study ID

NCT02911285

Run by

Medical University of South Carolina

People needed

90

Starts

2016-10-01

Expected to finish

2019-11-04

Last updated by the study team

2021-05-19

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female, any race or ethnicity, age 18 to 75 years old.
• U.S. military Veteran, including National Guard and Reservists.
• Able to comprehend English.
• Meet Diagnostic and Statistical Manual (DSM-5) criteria for current alcohol use disorder (AUD) and/or substance use disorder (SUD).
• Meet DSM-5 criteria for current PTSD or subthreshold PTSD. Subjects may also meet criteria for a mood disorder (except bipolar affective disorder, see Exclusion Criteria) or other anxiety disorders (e.g., panic disorder, agoraphobia, social phobia, generalized anxiety disorder). The inclusion of subjects with affective and other anxiety disorders is essential because of the marked frequency of the co-existence of mood and other anxiety disorders among patients with PTSD (Brady et al., 2000; Kessler et al., 2005).
• Subjects taking psychotropic medications will be required to be maintained on a stable dose for at least four weeks before treatment initiation. This is because initiation or change of medications during the course of the trial may interfere with interpretation of results.
• Must consent to random assignment to N-acetylcysteine (NAC) or placebo.
• Must consent to complete all treatment and follow-up visits.

You may not qualify if…

• Subjects meeting DSM-5 criteria for a history of or current psychotic or bipolar affective disorders, as the study protocol may be therapeutically insufficient.
• Subjects with a current eating disorder (bulimia, anorexia nervosa) or with dissociative identity disorder, as they are likely to require specific time-intensive psychotherapy.
• Subjects experiencing significant withdrawal symptoms, as evidence by a score of 10 or above on the Clinical Institute Withdrawal Assessment of Alcohol (CIWA).These subjects will be referred for clinical detoxification and may be re-assessed for study eligibility after medically supervised detoxification has been completed.
• Individuals considered an immediate suicide risk based on the Columbia Suicide Severity Rating Scale (C-SSRS) or who are likely to require hospitalization during the course of the study.
• Women who are pregnant, nursing or not practicing an effective form of birth control.
• Asthma or any clinically significant medical condition that in the opinion of the investigators would adversely affect safety or study participation.
• Use of carbamazepine, phenytoin, nitrous oxide, methotrexate, 6 azauridine triacetate, or nitroglycerin within the last 14 days or any other medication felt to have a hazardous interaction if taken with NAC.
• History of childhood or adult seizures of any cause.
• MRI exclusions: Claustrophobia; tattoos above the shoulders; permanent eyeliner or permanent artificial eyebrows; cardiac pacemaker; metal fragments in eye, skin, or body, including shrapnel; heart valve replacement; brain clips; venous umbrella; being a sheet-metal worker or welder; lifetime history of aneurysm surgery; intracranial bypass, renal, or aortic clips; prosthetic devices such as middle ear, eye, joint, or penile implants; joint replacements; non-removable hearing aid, neurostimulator, or insulin pump; shunts/stents; metal mesh/coil implants; metal plate/pin/screws/wires; or any other metal implants. Note that individuals who meet inclusion/exclusion criteria for the medication component of the study but not the MRI portion (e.g., excluded due to metal implants) will still be eligible to enroll in and complete the medication/treatment phase.
• Subjects on maintenance anxiolytic, antidepressant, or mood stabilizing medications which have been initiated during the past four weeks. If it is determined, based on clinical criteria, that a subject needs to be started on maintenance medications for anxiety, mood or psychotic symptoms during the course of the study, they will be discontinued from the treatment trial.

Where it is running

• Medical University of South Carolina — Charleston, South Carolina, United States
• Ralph H Johnson VA Medical Center — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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