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Trial record 1 of 1 for:    NCT02499029
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N-acetylcysteine in the Treatment of PTSD and Addiction (NAC)

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ClinicalTrials.gov Identifier: NCT02499029
Recruitment Status : Completed
First Posted : July 15, 2015
Results First Posted : August 29, 2018
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
Medical University of South Carolina

Tracking Information
First Submitted Date  ICMJE July 1, 2015
First Posted Date  ICMJE July 15, 2015
Results First Submitted Date  ICMJE February 10, 2017
Results First Posted Date  ICMJE August 29, 2018
Last Update Posted Date August 29, 2018
Study Start Date  ICMJE February 2013
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 31, 2018)
PTSD Symptoms [ Time Frame: 8 weeks ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 13, 2015)
  • PTSD Symptoms [ Time Frame: 8 weeks ]
    Clinician Administered PTSD Scale (CAPS)
  • Substance use [ Time Frame: 8 weeks ]
    Timeline Follow Back (TLFB)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 31, 2018)
  • Depression [ Time Frame: 8 weeks ]
    Beck Depression Inventory (BDI) The BDI measures presence and severity of depression. It has 21 questions that are rated from 0-3 with a highest possible score of 63. A higher score indicates a higher severity of depression.
  • Craving [ Time Frame: 8 weeks ]
    Visual Analogue Scale (VAS) The VAS measures alcohol craving on a scale from 0 to 10. A higher score indicates a higher level of craving.
  • PTSD Symptoms [ Time Frame: 8 weeks ]
    PTSD Checklist - Military (PCL-M) The PCL-M is a seventeen question self-report, scored on a scale from 1 to 5, with possible scores ranging from 17 to 85. The scores from each question are summed to get a total score (17-85). A higher total indicates a higher severity of PTSD symptoms.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2015)
  • Depression [ Time Frame: 8 weeks ]
    Beck Depression Inventory
  • Craving [ Time Frame: 8 weeks ]
    Visual Analogue Scale
  • PTSD Symptoms [ Time Frame: 8 weeks ]
    PTSD Checklist - Military (PCL-M)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE N-acetylcysteine in the Treatment of PTSD and Addiction
Official Title  ICMJE Glial Regulators for Treating Comorbid Posttraumatic Stress and Substance Abuse Disorders
Brief Summary Examine the effects of N-acetylcysteine on PTSD symptoms, craving and substance use in veterans with PTSD and comorbid substance use disorders.
Detailed Description With the increased number of military veterans returning from conflicts in Afghanistan and Iraq diagnosed with posttraumatic stress disorder (PTSD), there is a high vulnerability of these individuals to develop a substance use disorder (SUD). While there have been a host of studies focused largely on dopaminergic mechanisms of drug reward, they have not led to the development of adequate treatments for either preventing people diagnosed with PTSD from developing SUD or for treating comorbid PTSD/SUD. Based on extensive work with addictive drugs and preliminary data from our group, the investigators propose that stress impairs prefrontal cortex regulation of the basal ganglia habit circuitry and this pathology renders PTSD patients susceptible to developing SUD. Moreover, the known effects of addictive drugs to further impair prefrontal regulation are synergistic with this pathology, thereby making treatment of comorbid PTSD/SUD particularly difficult. Preclinical studies have revealed that glutamate levels within the nucleus accumbens have been implicated in drug seeking behavior in the animal model of relapse. The amino acid precursor N-acetylcysteine (NAC) appears to restore glutamate to normal levels and may also prevent glutamate levels from spiking following subsequent stimulant use. The primary goal of the proposed study is to evaluate the efficacy and safety of N-acetylcysteine in preventing relapse in drug dependent individuals with PTSD or subthreshold PTSD. Veterans with substance use disorders who have achieved at lease one week of abstinence will be randomized to either placebo or NAC (2400-3600mg/day) for 8 weeks.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • PTSD
  • Addiction
Intervention  ICMJE
  • Drug: N-acetylcysteine
    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.
    Other Name: NAC
  • Drug: Placebo
    Identical looking placebo pills were administered each week.
Study Arms  ICMJE
  • Experimental: N-Acetylcysteine
    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.
    Intervention: Drug: N-acetylcysteine
  • Placebo Comparator: Placebo
    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).
    Intervention: Drug: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 13, 2015)
35
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18-65 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).

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02499029
Other Study ID Numbers  ICMJE Pro00021986
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medical University of South Carolina
Study Sponsor  ICMJE Medical University of South Carolina
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Medical University of South Carolina
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP