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

• ClinicalTrials.gov Identifier: NCT01840345
• Recruitment Status: Completed
• First Posted: April 25, 2013
• Results First Posted: May 14, 2018
• Last Update Posted: May 14, 2018
• Sponsor: Virginia Commonwealth University
• Information provided by (Responsible Party): Virginia Commonwealth University

Tracking Information

• First Submitted Date: April 22, 2013
• First Posted Date: April 25, 2013
• Results First Submitted Date: February 15, 2018
• Results First Posted Date: May 14, 2018
• Last Update Posted Date: May 14, 2018
• Study Start Date: January 2014
• Actual Primary Completion Date: March 1, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 10, 2018)

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.

Original Primary Outcome Measures (submitted: April 24, 2013)

Opioid use [ Time Frame: 4 weeks ]

Measured in morphine equivalents

Current Secondary Outcome Measures (submitted: May 10, 2018)

• 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.
• 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.
• 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

Original Secondary Outcome Measures (submitted: April 24, 2013)

• Pain [ Time Frame: 4 weeks ]
  VAS Pain Quality Assessment Scale Pain Disability Index Pain Catastrophizing Scale
• Mood [ Time Frame: 4 weeks ]
  PHQ-9
• Stress [ Time Frame: 4 weeks ]
  PSS

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Role of N-acetyl-l-cysteine (NAC) as an Adjuvant to Opioid Treatment in Patients With Chronic Neuropathic Pain
• Official Title: The Role of N-acetyl-l-cysteine (NAC) as an Adjuvant to Opioid Treatment in Patients With Chronic Neuropathic Pain
• 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 Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Neuropathic Pain

Intervention

Drug: N-acetyl-l-cysteine

1200 mg BID x 4 weeks

Other Name: NAC

Study Arms

Experimental: N-acetyl-L-cysteine

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

Intervention: Drug: N-acetyl-l-cysteine

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 10, 2018): 11
• Original Estimated Enrollment (submitted: April 24, 2013): 40
• Actual Study Completion Date: April 1, 2017
• Actual Primary Completion Date: March 1, 2017 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01840345
• Other Study ID Numbers: HM14748
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Virginia Commonwealth University
• Original Responsible Party: Same as current
• Current Study Sponsor: Virginia Commonwealth University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Dace S Svikis, PhD; Virginia Commonwealth University

• PRS Account: Virginia Commonwealth University
• Verification Date: May 2018