Back to resultsThe Role of N-acetyl-l-cysteine (NAC) as an Adjuvant to Opioid Treatment in Patients With Chronic Neuropathic Pain
Primary Purpose
Neuropathic Pain
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
N-acetyl-l-cysteine
Sponsored by
About this trial
This is an interventional treatment trial for Neuropathic Pain focused on measuring uncontrolled, neuropathic pain
Eligibility 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
Sites / Locations
- Virginia Commonwealth University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
N-acetyl-L-cysteine
Arm Description
n-acetyl-l-cysteine 1200 mg BID x 4 weeks
Outcomes
Primary Outcome Measures
Opioid Use
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
Pain
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
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
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
Full Information
NCT ID
NCT01840345
First Posted
April 22, 2013
Last Updated
May 10, 2018
Sponsor
Virginia Commonwealth University
1. Study Identification
Unique Protocol Identification Number
NCT01840345
Brief Title
The Role of N-acetyl-l-cysteine (NAC) as an Adjuvant to Opioid Treatment in Patients With Chronic Neuropathic Pain
Official Title
The Role of N-acetyl-l-cysteine (NAC) as an Adjuvant to Opioid Treatment in Patients With Chronic Neuropathic Pain
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
March 1, 2017 (Actual)
Study Completion Date
April 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain
Keywords
uncontrolled, neuropathic pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
N-acetyl-L-cysteine
Arm Type
Experimental
Arm Description
n-acetyl-l-cysteine 1200 mg BID x 4 weeks
Intervention Type
Drug
Intervention Name(s)
N-acetyl-l-cysteine
Other Intervention Name(s)
NAC
Intervention Description
1200 mg BID x 4 weeks
Primary Outcome Measure Information:
Title
Opioid Use
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
Secondary Outcome Measure Information:
Title
Pain
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
Title
Mood
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
Title
Stress
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dace S Svikis, PhD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Role of N-acetyl-l-cysteine (NAC) as an Adjuvant to Opioid Treatment in Patients With Chronic Neuropathic Pain
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