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Clinical Trials/NCT01840345
NCT01840345CompletedPhase 2

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

Virginia Commonwealth University1 site in 1 country11 target enrollmentStarted: January 2014Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
11
Locations
1
Primary Endpoint
Opioid Use
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

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

Experimental

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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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The Role of N-acetyl-l-cysteine (NAC) as... | Clinical Trial