Clinical Trial for Alcohol Use Disorder and Post Traumatic Stress Disorder (PTSD)
Condition: Post Traumatic Stress Disorder (PTSD); Addiction; Alcohol Abuse
MeSH terms: Alcoholism; Stress Disorders, Traumatic; Behavior, Addictive; Alcohol Drinking; Stress Disorders, Post-Traumatic
Intervention: N-Acetylcysteine (NAC) Treatment; Cognitive Behavioral Therapy (CBT); Inactive Placebo Oral Capsule; Functional magnetic resonance imaging (fMRI); Proton magnetic resonance spectroscopy (MRS) Imaging
Intervention description: Participant will receive 12 weeks of Active Treatment NAC (2400 mg) daily. The study medication will be provided in blister packs in the form of 600 mg tablets. Each participant will be asked to take two (2) 600 mg tablets in the morning and two (2) 600 mg tablets in the evening.; Participant will receive 12 weeks of weekly cognitive-behavioral therapy, medication management, and AE monitoring.; Participant will receive 12 weeks of inactive placebo. The study medication will be provided in blister packs in the form of 600 mg tablets. Each participant will be asked to take two (2) 600 mg tablets in the morning and two (2) 600 mg tablets in the evening.; Participants will be given the option to complete Functional magnetic resonance imaging (fMRI) at two timepoints (pre-treatment and end of treatment).; Participants will be given the option to complete magnetic resonance spectroscopy (MRS) at two timepoints (pre-treatment and end of treatment).
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 182.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Post Traumatic Stress Disorder (PTSD); Addiction; Alcohol Use Disorder; Cognitive Behavioral Therapy; N-acetylcysteine (NAC)

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.
    

Eligibility 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 Diagnostic
             and Statistical Manual of Mental Disorders, Fifth Edition (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.

        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.