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
|Condition or disease||Intervention/treatment||Phase|
|Neuropathic Pain||Drug: N-acetyl-l-cysteine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
n-acetyl-l-cysteine 1200 mg BID x 4 weeks
1200 mg BID x 4 weeks
Other Name: NAC
- 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.
- 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
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
|United States, Virginia|
|Virginia Commonwealth University|
|Richmond, Virginia, United States, 23298|
|Principal Investigator:||Dace S Svikis, PhD||Virginia Commonwealth University|