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

  • STATUS
    Recruiting
  • End date
    Aug 1, 2022
  • participants needed
    200
  • sponsor
    Medical University of South Carolina
Updated on 24 January 2021
anxiety
substance use
behavior therapy
obsessive compulsive disorder
behavioral therapy
agoraphobia
psychoactive drugs
n-acetylcysteine
bipolar disorder
psychotropic drugs
panic disorder
cognitive therapy
social phobia
alcohol use disorder
post-traumatic stress disorder
obsessive-compulsive disorder
mood disorder

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.

Description

The primary objective of the proposed Phase II study is to evaluate the effects of N-acetylcysteine (NAC), in reducing (1) Alcohol Use Disorder (AUD) severity and (2) Post Traumatic Stress Disorder (PTSD) symptomatology among individuals (N=200) with current AUD and PTSD. We will also use functional magnetic resonance imaging (fMRI) and proton magnetic resonance spectroscopy (MRS) to investigate the neural circuitry and neurochemistry underlying comorbid AUD/PTSD and prognostic indicators of positive treatment response. Secondary objectives are to evaluate the effects of NAC on impairment in associated areas of functioning (e.g., depression, anxiety, sleep, risky behaviors). In order to accomplish this we will (1) employ an intent-to-treat, double-blind, placebo-controlled randomized controlled trial that will consist of 12 weeks of treatment with NAC (2400 mg per day) or placebo medication; (2) examine standardized, repeated dependent measures of clinical outcomes at baseline, week 6, week 12, and 3-, 6-, and 12-month follow-up; and (3) employ advanced neuroimaging methodologies, a laboratory cue paradigm, and collect biologic measures of alcohol consumption. All participants will also undergo weekly individual cognitive behavior therapy sessions (CBT).The following specific aims are proposed:

Specific Aim 1: To determine the efficacy of N-acetylcysteine (NAC), as compared to placebo, in reducing alcohol use severity (i.e., total standard drinks, percent days drinking, abstinence rates) and craving.

Specific Aim 2: To determine the efficacy of N-acetylcysteine (NAC), as compared to placebo, in reducing self-report and clinician-rated PTSD symptomatology.

Specific Aim 3: To use multimodal neuroimaging techniques to investigate the pathophysiology underlying AUD and comorbid PTSD, and prognostic indicators of treatment outcome.

The proposed study will answer critical questions regarding the potential of NAC as an effective pharmacotherapy for AUD and comorbid PTSD, and elucidate possible mechanisms underlying improved outcomes. This study has the particular advantage of building directly on positive preliminary findings by (1) further testing NAC in the treatment of individuals with co-occurring AUD/PTSD using a double-blind, placebo-controlled randomized design; (2) measuring functioning in related areas, such as depression and risky behaviors; (3) employing innovative measurements including neuroimaging and laboratory cue paradigms; and (4) employing a multidisciplinary team of experts who have successfully collaborated in the past and are uniquely qualified to implement this type of investigation. This project is directly responsive to the mission of the National Institute of Alcohol and Alcoholism (NIAAA) and the new AUD/PTSD initiative in that it seeks to evaluate a promising therapeutic agent for the treatment of AUD/PTSD and identify neurobiological mechanisms common to AUD/PTSD as potential treatment targets. The findings from this study have the potential to significantly improve the standard of patient care, advance the comorbidity science in this area, and decrease public health expenditures associated with AUD and comorbid PTSD.

Details
Condition Addiction, Post-Traumatic Stress Disorder, Alcohol abuse, Alcohol Use Disorder, Post-Traumatic Stress Disorders, Addictions, Alcohol Dependence, PTSD, addictive behaviors
Treatment Cognitive behavioral therapy, Placebo oral capsule, N-Acetylcysteine (NAC) Treatment
Clinical Study IdentifierNCT02966873
SponsorMedical University of South Carolina
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 70 yrs?
Gender: Male or Female
Do you have any of these conditions: Addictions or Post-Traumatic Stress Disorder or Post-Traumatic Stress Disorders or Addiction or Alcohol Dependence or Alcohol Use Disorder or Alcohol ...?
Do you have any of these conditions: Addiction or Post-Traumatic Stress Disorder or Post-Traumatic Stress Disorders or addictive behaviors or Alcohol abuse or Alcohol Use Disorder or Alco...?
Male or female; any race or ethnicity; age 18 to 70 years old
Subjects must be able to comprehend English
Meet DSM-5 criteria for current alcohol use disorder (AUD)
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
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
Must live within 50 miles (one hour) of MUSC in Charleston, SC or be willing to travel to MUSC for visits

Exclusion Criteria

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 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
\. 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
\. 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
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