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

Phase 2

Completed

• Conditions: Neuropathic Pain
• Interventions: Drug: N-acetyl-l-cysteine

• Registration Number: NCT01840345
• Lead Sponsor: Virginia Commonwealth University

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 Timeline

• Study First Submitted: 2013-04-22
• Study First Submitted QC: 2013-04-24
• Study First Posted: 2013-04-25
• Study Start: 2014-01
• Primary Completion: 2017-03-01
• Study Completion: 2017-04-01
• Results First Submitted: 2018-02-15
• Status Verified: 2018-05
• Results First Submitted QC: 2018-05-10
• Last Update Submitted: 2018-05-10
• Results First Posted: 2018-05-14
• Last Update Posted: 2018-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
N-acetyl-L-cysteine	N-acetyl-l-cysteine	n-acetyl-l-cysteine 1200 mg BID x 4 weeks

Primary Outcome Measures

Name	Time	Method
Opioid Use	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

Name	Time	Method
Stress	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
Pain	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	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.

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States