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

Neuropathic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01840345
• Other study ID #: HM14748
• Status: Completed
• Phase: Phase 2
• Start date: January 2014
• Est. completion date: April 1, 2017

Study information

• Verified date: May 2018
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is an open-label study to evaluate the safety and efficacy of N-acetyl-L-cysteine in patients with Chronic neuropathic pain.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: April 1, 2017
• Est. primary completion date: March 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain

Intervention

Drug:
• N-acetyl-l-cysteine
1200 mg BID x 4 weeks

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid Use	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.	Baseline, 4 weeks
Secondary	Pain	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.	Baseline, 4 weeks
Secondary	Mood	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.	Baseline, 4 weeks
Secondary	Stress	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	Baseline, 4 weeks