Clinical Trial for Alcohol Use Disorder and Post Traumatic Stress Disorder (PTSD) (NCT02966873) | Clinical Trial Compass
CompletedPhase 2
Clinical Trial for Alcohol Use Disorder and Post Traumatic Stress Disorder (PTSD)
United States182 participantsStarted 2016-10-01
Plain-language 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.
Who can participate
Age range18 Years ā 70 Years
SexALL
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Inclusion criteria
ā. Male or female; any race or ethnicity; age 18 to 70 years old.
ā. Subjects must be able to comprehend English.
ā. Meet DSM-5 criteria for current alcohol use disorder (AUD).
Exclusion criteria
ā. 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.
ā. Must consent to random assignment to N-acetylcysteine (NAC) or placebo.
ā. Must consent to complete all treatment and follow-up visits.
ā. Subjects meeting DSM-5 criteria for a history of or current psychotic or bipolar affective disorders, as the study protocol may be therapeutically insufficient.
ā. Subjects with a current eating disorder (bulimia, anorexia nervosa) or with dissociative identity disorder, as they are likely to require specific time-intensive psychotherapy.
ā. 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.
ā. Individuals considered an immediate suicide risk or who are likely to require hospitalization during the course of the study for suicidality.
What they're measuring
1
Change in Alcohol Use Severity
Timeframe: From baseline to week 12
2
Change in Alcohol Craving - Obsessive Subscale
Timeframe: From baseline to week 12
3
Change in Post Traumatic Stress Disorder Symptom Severity - Clinician Rated
Timeframe: From baseline to week 12
4
Change in Post Traumatic Stress Disorder Symptom Severity - Self Report
Timeframe: From baseline to week 12
5
Change in Alcohol Craving - Compulsive Subscale
Timeframe: From baseline to week 12
6
Change in Alcohol Use Severity - Percent Days Abstinent
ā. 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.