Trial Outcomes & Findings for The Role of N-acetyl-l-cysteine (NAC) as an Adjuvant to Opioid Treatment in Patients With Chronic Neuropathic Pain (NCT NCT01840345)

Last Updated: 2018-05-14

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

11 participants

Primary outcome timeframe

Baseline, 4 weeks

Results posted on

2018-05-14

Participant Flow

Participant milestones

Participant milestones
Measure	N-acetyl-L-cysteine n-acetyl-l-cysteine 1200 mg BID x 4 weeks N-acetyl-l-cysteine: 1200 mg BID x 4 weeks
Overall Study STARTED	11
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	N-acetyl-L-cysteine n=11 Participants n-acetyl-l-cysteine 1200 mg BID x 4 weeks N-acetyl-l-cysteine: 1200 mg BID x 4 weeks
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 4 weeks

Outcome measures

Outcome measures
Measure	N-acetyl-L-cysteine n=10 Participants n-acetyl-l-cysteine 1200 mg BID x 4 weeks N-acetyl-l-cysteine: 1200 mg BID x 4 weeks
Opioid Use Baseline	101.24 morphine equivalent dose Standard Deviation 89.93
Opioid Use 4 weeks	104.56 morphine equivalent dose Standard Deviation 96.66

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	N-acetyl-L-cysteine n=10 Participants n-acetyl-l-cysteine 1200 mg BID x 4 weeks N-acetyl-l-cysteine: 1200 mg BID x 4 weeks
Pain Baseline	6.38 mm on 100 mm scale Standard Deviation 1.58
Pain 4 weeks	5.95 mm on 100 mm scale Standard Deviation 1.96

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	N-acetyl-L-cysteine n=10 Participants n-acetyl-l-cysteine 1200 mg BID x 4 weeks N-acetyl-l-cysteine: 1200 mg BID x 4 weeks
Mood 4 weeks	9.7 units on a scale Standard Deviation 6.5
Mood Baseline	10.4 units on a scale Standard Deviation 4.9

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	N-acetyl-L-cysteine n=10 Participants n-acetyl-l-cysteine 1200 mg BID x 4 weeks N-acetyl-l-cysteine: 1200 mg BID x 4 weeks
Stress Baseline	21.5 units on a scale Standard Deviation 3.6
Stress 4 weeks	16.6 units on a scale Standard Deviation 1.4

Adverse Events

N-acetyl-L-cysteine

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	N-acetyl-L-cysteine n=11 participants at risk n-acetyl-l-cysteine 1200 mg BID x 4 weeks N-acetyl-l-cysteine: 1200 mg BID x 4 weeks
Gastrointestinal disorders Constipation	18.2% 2/11 • Number of events 2 • A physical examination was done at Baseline. Then, adverse events were assessed at each study visit throughout the study and follow-up periods. All participants were asked about side effects and adverse events on a weekly basis, and any adverse events reported by the patients were evaluated by study staff.
Gastrointestinal disorders Diarrhea	27.3% 3/11 • Number of events 4 • A physical examination was done at Baseline. Then, adverse events were assessed at each study visit throughout the study and follow-up periods. All participants were asked about side effects and adverse events on a weekly basis, and any adverse events reported by the patients were evaluated by study staff.
Gastrointestinal disorders Nausea	36.4% 4/11 • Number of events 4 • A physical examination was done at Baseline. Then, adverse events were assessed at each study visit throughout the study and follow-up periods. All participants were asked about side effects and adverse events on a weekly basis, and any adverse events reported by the patients were evaluated by study staff.
Gastrointestinal disorders Gastroesophageal reflux	45.5% 5/11 • Number of events 6 • A physical examination was done at Baseline. Then, adverse events were assessed at each study visit throughout the study and follow-up periods. All participants were asked about side effects and adverse events on a weekly basis, and any adverse events reported by the patients were evaluated by study staff.
Gastrointestinal disorders Loss of appetite	18.2% 2/11 • Number of events 2 • A physical examination was done at Baseline. Then, adverse events were assessed at each study visit throughout the study and follow-up periods. All participants were asked about side effects and adverse events on a weekly basis, and any adverse events reported by the patients were evaluated by study staff.
Gastrointestinal disorders Dry mouth	18.2% 2/11 • Number of events 2 • A physical examination was done at Baseline. Then, adverse events were assessed at each study visit throughout the study and follow-up periods. All participants were asked about side effects and adverse events on a weekly basis, and any adverse events reported by the patients were evaluated by study staff.
Skin and subcutaneous tissue disorders Itching	18.2% 2/11 • Number of events 2 • A physical examination was done at Baseline. Then, adverse events were assessed at each study visit throughout the study and follow-up periods. All participants were asked about side effects and adverse events on a weekly basis, and any adverse events reported by the patients were evaluated by study staff.
Endocrine disorders Sweating	18.2% 2/11 • Number of events 2 • A physical examination was done at Baseline. Then, adverse events were assessed at each study visit throughout the study and follow-up periods. All participants were asked about side effects and adverse events on a weekly basis, and any adverse events reported by the patients were evaluated by study staff.
Nervous system disorders Sleepy	9.1% 1/11 • Number of events 2 • A physical examination was done at Baseline. Then, adverse events were assessed at each study visit throughout the study and follow-up periods. All participants were asked about side effects and adverse events on a weekly basis, and any adverse events reported by the patients were evaluated by study staff.
Gastrointestinal disorders chronic colonic ileus	9.1% 1/11 • Number of events 1 • A physical examination was done at Baseline. Then, adverse events were assessed at each study visit throughout the study and follow-up periods. All participants were asked about side effects and adverse events on a weekly basis, and any adverse events reported by the patients were evaluated by study staff.
Nervous system disorders Headache	9.1% 1/11 • Number of events 1 • A physical examination was done at Baseline. Then, adverse events were assessed at each study visit throughout the study and follow-up periods. All participants were asked about side effects and adverse events on a weekly basis, and any adverse events reported by the patients were evaluated by study staff.
Nervous system disorders Insomnia	9.1% 1/11 • Number of events 1 • A physical examination was done at Baseline. Then, adverse events were assessed at each study visit throughout the study and follow-up periods. All participants were asked about side effects and adverse events on a weekly basis, and any adverse events reported by the patients were evaluated by study staff.
Vascular disorders Hypertension	9.1% 1/11 • Number of events 1 • A physical examination was done at Baseline. Then, adverse events were assessed at each study visit throughout the study and follow-up periods. All participants were asked about side effects and adverse events on a weekly basis, and any adverse events reported by the patients were evaluated by study staff.
Musculoskeletal and connective tissue disorders Muscle tightness	9.1% 1/11 • Number of events 1 • A physical examination was done at Baseline. Then, adverse events were assessed at each study visit throughout the study and follow-up periods. All participants were asked about side effects and adverse events on a weekly basis, and any adverse events reported by the patients were evaluated by study staff.
Musculoskeletal and connective tissue disorders Knee pain	9.1% 1/11 • Number of events 1 • A physical examination was done at Baseline. Then, adverse events were assessed at each study visit throughout the study and follow-up periods. All participants were asked about side effects and adverse events on a weekly basis, and any adverse events reported by the patients were evaluated by study staff.

Additional Information

Dr. Dace Svikis

Virginia Commonwealth University

Phone: (804) 827-1184

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place