N-acetylcysteine in the Treatment of PTSD and Addiction

NCT02499029 | Completed Phase 2 Results DMC

• 1 other identifier: Pro00021986
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

Brief Summary

Examine the effects of N-acetylcysteine on PTSD symptoms, craving and substance use in veterans with PTSD and comorbid substance use disorders.

Conditions

PTSD; Addiction

Outcome Measures

Primary Outcomes (1)

• PTSD Symptoms

  Clinician Administered PTSD Scale IV (CAPS) The CAPS IV measures seventeen symptoms based on intensity and frequency. Intensity and frequency scores are summed to create a severity score for each question. Severity scores are summed to get a total score. A higher total score indicates a higher severity of PTSD symptoms.The full range for CAPS IV is 0-136.

  8 weeks

Secondary Outcomes (3)

• Depression

  8 weeks

• Craving

  8 weeks

• PTSD Symptoms

  8 weeks

Study Arms (2)

N-Acetylcysteine

EXPERIMENTAL

Eligible participants were randomized to either NAC (2400 mg/day) or placebo for 8 weeks. The starting dose of NAC was 1200 mg twice daily (2400 mg/day). All NAC and placebo capsules contained riboflavin 25 mg, which was used as a biomarker for medication compliance.

Drug: N-acetylcysteine

Placebo

PLACEBO COMPARATOR

Identical appearing placebo capsules were dispensed. All NAC and placebo capsules contained riboflavin 25 mg, which was used as a biomarker for medication compliance. Study medications (USP-grade NAC and matched placebo capsules) dispensed to participants by the medical clinician or study staff. Treatment assignment followed a pre-arranged randomization scheme and was carried out by study personnel at the pharmacy (i.e., personnel not involved in clinical management of participants to preserve the double-blind design).

Drug: Placebo

Interventions

N-acetylcysteine DRUG

NAC pills were administered each week. NAC is a N acetyl pro-drug of the naturally-occurring amino acid cystine. NAC is a white, crystalline powder with the molecular formula C5H9NO3S and with a molecular weight of 163.2.

Also known as: NAC

N-Acetylcysteine

Placebo DRUG

Identical looking placebo pills were administered each week.

Placebo

Eligibility Criteria

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

You may qualify if:

• year old
• U.S. military Veteran, Reservist, or National Guard member
• DSM-IV diagnostic criteria for current (past 6 months) SUD and PTSD or subthreshold PTSD (i.e., met criteria for cluster B (re-experiencing) and either cluster C (avoidance) or D (hyperarousal), as well as duration of one month and clinically significant impairment)
• Score of \> 21 on the Mini-Mental State Exam (MMSE).

You may not qualify if:

• Unstable medical conditions
• Bipolar or psychotic disorders
• Seizures or asthma
• Prior treatment with NAC
• Suicidality
• Enrolled in ongoing PTSD treatment (pharmacotherapy or psychosocial)
• Females: could not be pregnant or lactating

Sponsors & Collaborators

• Medical University of South Carolina: lead

Related Publications (1)

• Back SE, McCauley JL, Korte KJ, Gros DF, Leavitt V, Gray KM, Hamner MB, DeSantis SM, Malcolm R, Brady KT, Kalivas PW. A Double-Blind, Randomized, Controlled Pilot Trial of N-Acetylcysteine in Veterans With Posttraumatic Stress Disorder and Substance Use Disorders. J Clin Psychiatry. 2016 Nov;77(11):e1439-e1446. doi: 10.4088/JCP.15m10239.

  PMID: 27736051 RESULT

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Behavior, Addictive

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Limitations and Caveats

Small sample size, Veterans only which may limit ability to generalize to other populations, self-report measures may introduce bias.

Results Point of Contact

• Title: Sudie Back, PhD
• Organization: MUSC

backs@musc.edu

843-792-9383

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: July 1, 2015
• First Posted: July 15, 2015
• Study Start: February 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: August 29, 2018
• Results First Posted: August 29, 2018

Record last verified: 2018-07