Neuropathic Pain
Conditions
Keywords
uncontrolled, 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.
Interventions
1200 mg BID x 4 weeks
Sponsors
Virginia Commonwealth University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Use | 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
| Measure | Time frame | Description |
|---|---|---|
| Pain | 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 | 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 | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| N-acetyl-L-cysteine n-acetyl-l-cysteine 1200 mg BID x 4 weeks
N-acetyl-l-cysteine: 1200 mg BID x 4 weeks | 11 |
| Total | 11 |
Baseline characteristics
| Characteristic | N-acetyl-L-cysteine |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 3 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 11 |
| other Total, other adverse events | 10 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
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.
Time frame: Baseline, 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| N-acetyl-L-cysteine | Opioid Use | 4 weeks | 104.56 morphine equivalent dose | Standard Deviation 96.66 |
| N-acetyl-L-cysteine | Opioid Use | Baseline | 101.24 morphine equivalent dose | Standard Deviation 89.93 |
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.
Time frame: Baseline, 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| N-acetyl-L-cysteine | Mood | Baseline | 10.4 units on a scale | Standard Deviation 4.9 |
| N-acetyl-L-cysteine | Mood | 4 weeks | 9.7 units on a scale | Standard Deviation 6.5 |
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.
Time frame: Baseline, 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| N-acetyl-L-cysteine | Pain | Baseline | 6.38 mm on 100 mm scale | Standard Deviation 1.58 |
| N-acetyl-L-cysteine | Pain | 4 weeks | 5.95 mm on 100 mm scale | Standard Deviation 1.96 |
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
Time frame: Baseline, 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| N-acetyl-L-cysteine | Stress | Baseline | 21.5 units on a scale | Standard Deviation 3.6 |
| N-acetyl-L-cysteine | Stress | 4 weeks | 16.6 units on a scale | Standard Deviation 1.4 |