Phase 2
N=11
The Role of N-acetyl-l-cysteine (NAC) as an Adjuvant to Opioid Treatment in Patients With Chronic Neuropathic Pain
Neuropathic Pain
Bottom Line
View on ClinicalTrials.gov: NCT01840345 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
May 2018
Primary outcome: Primary: Opioid Use — 101.24; 104.56 morphine equivalent dose
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- N-acetyl-l-cysteine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Virginia Commonwealth University
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Opioid Use |
101.24; 104.56 | — |
| SECONDARY Pain |
6.38; 5.95 | — |
| SECONDARY Mood |
10.4; 9.7 | — |
| SECONDARY Stress |
21.5; 16.6 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01840345). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.