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The Role of N-acetyl-l-cysteine (NAC) as an Adjuvant to Opioid Treatment in Patients With Chronic Neuropathic Pain

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ClinicalTrials.gov Identifier: NCT01840345
Recruitment Status : Completed
First Posted : April 25, 2013
Results First Posted : May 14, 2018
Last Update Posted : May 14, 2018
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

Tracking Information
First Submitted Date  ICMJE April 22, 2013
First Posted Date  ICMJE April 25, 2013
Results First Submitted Date  ICMJE February 15, 2018
Results First Posted Date  ICMJE May 14, 2018
Last Update Posted Date May 14, 2018
Study Start Date  ICMJE January 2014
Actual Primary Completion Date March 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 10, 2018)
Opioid Use [ Time Frame: Baseline, 4 weeks ]
The amount of opioid medication used was recorded. Then, it was converted to morphine equivalents (https://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovContra/Downloads/Opioid-Morphine-EQ-Conversion-Factors-March-2015.pdf). Opioid use was measured over a 2-week baseline period. Then, the average opioid medication use/week was calculated. This was compared to the average opioid medication use/week after 4 weeks of NAC.
Original Primary Outcome Measures  ICMJE
 (submitted: April 24, 2013)
Opioid use [ Time Frame: 4 weeks ]
Measured in morphine equivalents
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 10, 2018)
  • Pain [ Time Frame: Baseline, 4 weeks ]
    Pain intensity will be measured by using the 100-point Visual Analogue Scale, a 100-mm horizontal line with anchors of "no pain at all" (at 0) and "worst pain imaginable" (at 100mm) on which patients' pain intensities are measured.
  • Mood [ Time Frame: Baseline, 4 weeks ]
    Mood will be assessed by using the Patient Health Questionnaire (PHQ-9), a validated 9-question assessment of depression with total scores ranging from 0-27. Higher score = worse depression.
  • Stress [ Time Frame: Baseline, 4 weeks ]
    Stress will be measured by the Perceived Stress Scale ((PSS), a 10-item instrument for measuring the perception of stress, with total scores ranging from 0-40. Higher scores = higher perceived stress
Original Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2013)
  • Pain [ Time Frame: 4 weeks ]
    VAS Pain Quality Assessment Scale Pain Disability Index Pain Catastrophizing Scale
  • Mood [ Time Frame: 4 weeks ]
    PHQ-9
  • Stress [ Time Frame: 4 weeks ]
    PSS
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Role of N-acetyl-l-cysteine (NAC) as an Adjuvant to Opioid Treatment in Patients With Chronic Neuropathic Pain
Official Title  ICMJE The Role of N-acetyl-l-cysteine (NAC) as an Adjuvant to Opioid Treatment in Patients With Chronic Neuropathic Pain
Brief Summary This study will test whether treatment with N-acetyl-L-cysteine (NAC) is safe and decreases pain in patients with chronic neuropathic pain. The investigators hypothesize that NAC will be a useful adjunct to opioid treatment in chronic neuropathic pain.
Detailed Description This is an open-label study to evaluate the safety and efficacy of N-acetyl-L-cysteine in patients with Chronic neuropathic pain.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neuropathic Pain
Intervention  ICMJE Drug: N-acetyl-l-cysteine
1200 mg BID x 4 weeks
Other Name: NAC
Study Arms  ICMJE Experimental: N-acetyl-L-cysteine
n-acetyl-l-cysteine 1200 mg BID x 4 weeks
Intervention: Drug: N-acetyl-l-cysteine
Publications * Not Provided

*   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: May 10, 2018)
11
Original Estimated Enrollment  ICMJE
 (submitted: April 24, 2013)
40
Actual Study Completion Date  ICMJE April 1, 2017
Actual Primary Completion Date March 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18-65 years old
  • non-cancer neuropathic pain
  • stable dose of opioids for pain
  • using breakthrough pain meds
  • still with persistent pain per VAS

Exclusion Criteria:

  • pregnant or nursing
  • serious medical or psychiatric illness (including uncontrolled hypertension)
  • active stomach ulcer, history or seizures or asthma
  • breakthrough pain meds other than opioids
  • using illicit drugs
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01840345
Other Study ID Numbers  ICMJE HM14748
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Virginia Commonwealth University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Virginia Commonwealth University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dace S Svikis, PhD Virginia Commonwealth University
PRS Account Virginia Commonwealth University
Verification Date May 2018

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