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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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Neuropathic Pain
Intervention Drug: N-acetyl-l-cysteine
Enrollment 11
Recruitment Details  
Pre-assignment Details  
Arm/Group Title N-acetyl-L-cysteine
Hide Arm/Group Description

n-acetyl-l-cysteine 1200 mg BID x 4 weeks

N-acetyl-l-cysteine: 1200 mg BID x 4 weeks

Period Title: Overall Study
Started 11
Completed 10
Not Completed 1
Arm/Group Title N-acetyl-L-cysteine
Hide Arm/Group Description

n-acetyl-l-cysteine 1200 mg BID x 4 weeks

N-acetyl-l-cysteine: 1200 mg BID x 4 weeks

Overall Number of Baseline Participants 11
Hide Baseline Analysis Population Description
One patient did not complete study so was not included in efficacy analysis
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
<=18 years
0
   0.0%
Between 18 and 65 years
11
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female
7
  63.6%
Male
4
  36.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
8
  72.7%
White
3
  27.3%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Opioid Use
Hide Description 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.
Time Frame Baseline, 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title N-acetyl-L-cysteine
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n-acetyl-l-cysteine 1200 mg BID x 4 weeks

N-acetyl-l-cysteine: 1200 mg BID x 4 weeks

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: morphine equivalent dose
Baseline 101.24  (89.93)
4 weeks 104.56  (96.66)
2.Secondary Outcome
Title Pain
Hide Description 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.
Time Frame Baseline, 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title N-acetyl-L-cysteine
Hide Arm/Group Description:

n-acetyl-l-cysteine 1200 mg BID x 4 weeks

N-acetyl-l-cysteine: 1200 mg BID x 4 weeks

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: mm on 100 mm scale
Baseline 6.38  (1.58)
4 weeks 5.95  (1.96)
3.Secondary Outcome
Title Mood
Hide Description 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.
Time Frame Baseline, 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title N-acetyl-L-cysteine
Hide Arm/Group Description:

n-acetyl-l-cysteine 1200 mg BID x 4 weeks

N-acetyl-l-cysteine: 1200 mg BID x 4 weeks

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 10.4  (4.9)
4 weeks 9.7  (6.5)
4.Secondary Outcome
Title Stress
Hide Description 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
Time Frame Baseline, 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title N-acetyl-L-cysteine
Hide Arm/Group Description:

n-acetyl-l-cysteine 1200 mg BID x 4 weeks

N-acetyl-l-cysteine: 1200 mg BID x 4 weeks

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 21.5  (3.6)
4 weeks 16.6  (1.4)
Time Frame A physical examination was done at Baseline. Then, adverse events were assessed at each study visit throughout the study and follow-up periods.
Adverse Event Reporting Description All participants were asked about side effects and adverse events on a weekly basis, and any adverse events reported by the patients were evaluated by study staff.
 
Arm/Group Title N-acetyl-L-cysteine
Hide Arm/Group Description

n-acetyl-l-cysteine 1200 mg BID x 4 weeks

N-acetyl-l-cysteine: 1200 mg BID x 4 weeks

All-Cause Mortality
N-acetyl-L-cysteine
Affected / at Risk (%)
Total   0/11 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
N-acetyl-L-cysteine
Affected / at Risk (%) # Events
Total   0/11 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
N-acetyl-L-cysteine
Affected / at Risk (%) # Events
Total   10/11 (90.91%)    
Endocrine disorders   
Sweating   2/11 (18.18%)  2
Gastrointestinal disorders   
Constipation   2/11 (18.18%)  2
Diarrhea   3/11 (27.27%)  4
Nausea   4/11 (36.36%)  4
Gastroesophageal reflux   5/11 (45.45%)  6
Loss of appetite   2/11 (18.18%)  2
Dry mouth   2/11 (18.18%)  2
chronic colonic ileus   1/11 (9.09%)  1
Musculoskeletal and connective tissue disorders   
Muscle tightness   1/11 (9.09%)  1
Knee pain   1/11 (9.09%)  1
Nervous system disorders   
Sleepy   1/11 (9.09%)  2
Headache   1/11 (9.09%)  1
Insomnia   1/11 (9.09%)  1
Skin and subcutaneous tissue disorders   
Itching   2/11 (18.18%)  2
Vascular disorders   
Hypertension   1/11 (9.09%)  1
Indicates events were collected by systematic assessment
All adverse events reported regardless of causality
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Dace Svikis
Organization: Virginia Commonwealth University
Phone: (804) 827-1184
EMail: dssvikis@vcu.edu
Layout table for additonal information
Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01840345     History of Changes
Other Study ID Numbers: HM14748
First Submitted: April 22, 2013
First Posted: April 25, 2013
Results First Submitted: February 15, 2018
Results First Posted: May 14, 2018
Last Update Posted: May 14, 2018