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

• Status: Active, not recruiting
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized controlled Phase II clinical trial designed to evaluate the effects of N-acetylcysteine (NAC) in reducing Alcohol Use Disorder (AUD) severity and Post Traumatic Stress Disorder (PTSD) symptomatology among individuals with current AUD and PTSD.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Medical University of South Carolina
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA); National Institutes of Health (NIH)
• Treatments: Acetylcysteine; Ethanol; N-monoacetylcystine

Criteria

Inclusion Criteria:

1. Male or female; any race or ethnicity; age 18 to 70 years old.

2. Subjects must be able to comprehend English.

3. Meet DSM-5 criteria for current alcohol use disorder (AUD).

4. 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 (panic disorder, agoraphobia, social phobia, generalized anxiety disorder, or obsessive compulsive 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 AUD and PTSD (Brady et al., 2000; Kessler et al., 2005). Subjects may meet DSM-5 criteria for another substance use disorder as long as AUD is the primary substance of choice.

5. 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.

6. Must consent to random assignment to N-acetylcysteine (NAC) or placebo.

7. Must consent to complete all treatment and follow-up visits.

8. Must live within 50 miles (one hour) of MUSC in Charleston, SC or be willing to travel to MUSC for visits.

Exclusion Criteria:

1. Subjects meeting DSM-5 criteria for a history of or current psychotic or bipolar affective disorders, as the study protocol may be therapeutically insufficient.

2. Subjects with a current eating disorder (bulimia, anorexia nervosa) or with dissociative identity disorder, as they are likely to require specific time-intensive psychotherapy.

3. 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.

4. Individuals considered an immediate suicide risk or who are likely to require hospitalization during the course of the study for suicidality.

Women who are pregnant, nursing or not practicing an effective form of birth control.

5. Evidence of liver failure; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than 3 times the upper limit of normal; asthma or any clinically significant medical condition that in the opinion of the investigator would adversely affect safety or study participation.

6. 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.

7. History of childhood or adult seizures of any cause.