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

NCT01840345 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: HM14748
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuropathic Pain

Keywords

uncontrolled; neuropathic pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Pain

  Baseline, 4 weeks

• Mood

  Baseline, 4 weeks

• Stress

  Baseline, 4 weeks

Study Arms (1)

N-acetyl-L-cysteine

EXPERIMENTAL

n-acetyl-l-cysteine 1200 mg BID x 4 weeks

Drug: N-acetyl-l-cysteine

Interventions

N-acetyl-l-cysteine DRUG

1200 mg BID x 4 weeks

Also known as: NAC

N-acetyl-L-cysteine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• non-cancer neuropathic pain
• stable dose of opioids for pain
• using breakthrough pain meds
• still with persistent pain per VAS

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Neuralgia

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Limitations and Caveats

All adverse events reported regardless of causality

Results Point of Contact

• Title: Dr. Dace Svikis
• Organization: Virginia Commonwealth University

dssvikis@vcu.edu

(804) 827-1184

Study Officials

• Dace S Svikis, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2013
• First Posted: April 25, 2013
• Study Start: January 1, 2014
• Primary Completion: March 1, 2017
• Study Completion: April 1, 2017
• Last Updated: May 14, 2018
• Results First Posted: May 14, 2018

Record last verified: 2018-05

Locations

US (1)