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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Neuropathic Pain Drug: N-acetyl-l-cysteine Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Role of N-acetyl-l-cysteine (NAC) as an Adjuvant to Opioid Treatment in Patients With Chronic Neuropathic Pain
Study Start Date : January 2014
Actual Primary Completion Date : March 1, 2017
Actual Study Completion Date : April 1, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: N-acetyl-L-cysteine
n-acetyl-l-cysteine 1200 mg BID x 4 weeks
 Drug: N-acetyl-l-cysteine
1200 mg BID x 4 weeks
Other Name: NAC


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01840345


Locations
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United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
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Principal Investigator: Dace S Svikis, PhD Virginia Commonwealth University
  Study Documents (Full-Text)

Documents provided by Virginia Commonwealth University:
Study Protocol and Statistical Analysis Plan  [PDF] August 8, 2013

More Information
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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01840345    
Other Study ID Numbers: HM14748
First Posted: April 25, 2013    Key Record Dates
Results First Posted: May 14, 2018
Last Update Posted: May 14, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Virginia Commonwealth University:
uncontrolled
neuropathic pain
Additional relevant MeSH terms:
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Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
 Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes