NAC for Treating Comorbid PTSD and SUD

NCT02911285 | Completed Phase 2 Results DMC

• 1 other identifier: Pro00052757
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Posttraumatic Stress Disorder (PTSD); Alcohol Use Disorder (AUD); Substance Use Disorder (SUD)

Keywords

Alcohol; PTSD; Trauma; Veteran; Substance; Drug; Post Traumatic Stress Disorder; Military

Outcome Measures

Primary Outcomes (4)

• Change in Alcohol Use Disorder Severity

  Change in Alcohol Use Disorder Severity as measured by change in average drinking days per week from baseline to week 8. Greater reduction in drinking days indicates better treatment outcomes. Drinking days measured over 1 week periods (7 days). Scale ranges from 0 days to 7 days.

  From baseline to week 8 of treatment

• Change in Post Traumatic Stress Disorder Severity

  Change in post traumatic stress disorder severity as measured by Change in Clinician Administered PTSD Scale (CAPS-5) score from baseline to week 8. Greater change/reduction in score indicates better outcomes and greater reduction in PTSD symptomatology. (minimum score of 0 = absent to a maximum score of 80 = extreme)

  From baseline to week 8

• Change in Alcohol Craving

  Change in Alcohol craving as measured by change in Obsessive Compulsive Drinking Scale (OCDS) Total Score. Greater change/reduction in score indicates better outcomes and reduced alcohol craving. (Scores range from 0 to 56)

  From baseline to week 8

• Change in Post Traumatic Stress Disorder Severity

  Post traumatic stress disorder symptoms as measured by change/reduction in score of post traumatic stress disorder checklist (PCL-5) from baseline to week 8. Greater reduction in score indicates better treatment outcomes. (minimum score of 0 = absent to a maximum score of 80 = extreme)

  From baseline to week 8

Study Arms (2)

NAC/CBT

EXPERIMENTAL

Participants will receive N-acetylcysteine (NAC) and Cognitive Behavioral Therapy (CBT) for 8 weeks.

Drug: N-acetylcysteine; Behavioral: Cognitive behavioral therapy

Placebo/CBT

PLACEBO COMPARATOR

Participants will receive placebo pills and CBT for 8 weeks.

Drug: Placebo; Behavioral: Cognitive behavioral therapy

Interventions

N-acetylcysteine DRUG

1200mg bid (2400mg/day)

Also known as: NAC

NAC/CBT

Placebo DRUG

Placebo pills bid

Placebo/CBT

Cognitive behavioral therapy BEHAVIORAL

CBT for AUD/SUD, one hour/once a week

Also known as: CBT

NAC/CBT; Placebo/CBT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• United States Department of Defense: collaborator
• Institute for Translational Neuroscience: collaborator

Study Sites (2)

Medical University of South Carolina

Charleston, South Carolina, 29401, United States

Location

Ralph H Johnson VA Medical Center

Charleston, South Carolina, 29401, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Alcoholism; Substance-Related Disorders; Wounds and Injuries

Interventions

Acetylcysteine; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Alcohol-Related Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Stacey Sellers, Program Manager
• Organization: Medical University of South Carolina

sellersst@musc.edu

843-792-5807

Study Officials

• Sudie Back, Ph.D.

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2016
• First Posted: September 22, 2016
• Study Start: October 1, 2016
• Primary Completion: August 5, 2019
• Study Completion: November 4, 2019
• Last Updated: May 19, 2021
• Results First Posted: May 19, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)