The Role of N-acetyl-l-cysteine (NAC) as an Adjuvant to Opioid Treatment in Patients With Chronic Neuropathic Pain
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- Opioid Use
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
N-acetyl-L-cysteine
n-acetyl-l-cysteine 1200 mg BID x 4 weeks
Intervention: N-acetyl-l-cysteine (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- Pain(Baseline, 4 weeks)
- Mood(Baseline, 4 weeks)
- Stress(Baseline, 4 weeks)
