Skip to main content
OpenTrials
Completed

NCT Number: NCT01840345

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Neuropathic Pain Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

N-acetyl-L-cysteine

Drug

1200 mg BID x 4 weeks

Other names: NAC

Primary outcomes

  1. 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

  1. Pain

    Time frame: 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.

  2. Mood

    Time frame: 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.

  3. Stress

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Apr 25, 2013
Registry last updated
May 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.