Neuropathic PainPhase 2NCT01840345

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

A Phase 2 study testing N-acetyl-l-cysteine in people with Neuropathic Pain, run by Virginia Commonwealth University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Neuropathic Pain
What is being tested?: N-acetyl-l-cysteine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 11 participants
Where: 1 siteUnited States
Study dates: Jan 2014to 1 Apr 2017
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

18-65 years old
non-cancer neuropathic pain
stable dose of opioids for pain
using breakthrough pain meds
still with persistent pain per VAS

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Virginia Commonwealth University
Richmond, Virginia, 23298

Other trials in United States

About this study

Read the 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.

Conditions: Neuropathic Pain
Being tested: N-acetyl-l-cysteine
Keywords: uncontrolled, neuropathic pain
Medical subject headings: Neuralgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

N-acetyl-l-cysteineDrug
Also called NAC
1200 mg BID x 4 weeks

Study groups in NCT01840345
Study group	Role	What they receive
N-acetyl-L-cysteine	Experimental	n-acetyl-l-cysteine 1200 mg BID x 4 weeks Receives: Drug: N-acetyl-l-cysteine

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline, 4 weeks

Secondary outcomes (3)

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.
Measured: Baseline, 4 weeks
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.
Measured: Baseline, 4 weeks
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
Measured: Baseline, 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 20141 Apr 2017

First posted25 Apr 2013 (estimated)
Study startJan 2014
Primary completion1 Mar 2017
Study completion1 Apr 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Neuropathic PainStudies of the same condition, open and under way.
More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01840345
Sponsor's protocol ID: HM14748
Status last verified: May 2018
First submitted: 22 Apr 2013
Last updated: 14 May 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Neuropathic Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 14 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Role of N-acetyl-l-cysteine (NAC) as an Adjuvant to Opioid Treatment in Patients With Chronic Neuropathic Pain
ClinicalTrials.gov ID: NCT01840345
Acronym / sponsor ID: HM14748
Conditions: Neuropathic Pain
Keywords: uncontrolled, neuropathic pain
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 11 participants (actual)
Lead sponsor: Virginia Commonwealth UniversityUniversity, hospital or other
Study start: Jan 2014
Primary completion: 1 Mar 2017 (actual)
Study completion: 1 Apr 2017 (actual)
First posted: 25 Apr 2013 (estimated)
Results: Posted 14 May 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
N-acetyl-L-cysteine	Experimental	Drug: N-acetyl-l-cysteinen-acetyl-l-cysteine 1200 mg BID x 4 weeks

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

18-65 years old
non-cancer neuropathic pain
stable dose of opioids for pain
using breakthrough pain meds
still with persistent pain per VAS

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
N-acetyl-l-cysteineAlso: NAC1200 mg BID x 4 weeks	Drug	N-acetyl-L-cysteine

Primary outcome

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.

3 secondary outcomes

Pain
Time frame: Baseline, 4 weeks
Mood
Time frame: Baseline, 4 weeks
Stress
Time frame: Baseline, 4 weeks

Results and safety

Results posted to the registry on 14 May 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
N-acetyl-L-cysteine	11	10

Primary outcome: Opioid Use

Time frame: Baseline, 4 weeks. Mean (Standard Deviation). Unit: morphine equivalent dose

Measure	N-acetyl-L-cysteine n = 10
Baseline	101.24 (89.93)
4 weeks	104.56 (96.66)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: A physical examination was done at Baseline. Then, adverse events were assessed at each study visit throughout the study and follow-up periods.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
N-acetyl-L-cysteine	0 of 11 (0%)	10 of 11 (90.9%)	0 of 11

Limitations and caveats (from the sponsor): All adverse events reported regardless of causality

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Neuropathic Pain

RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Enrolling by invitationPhase 4
Low Dose Naltrexone Therapy for Complex Regional Pain Syndrome
Complex Regional Pain Syndrome, Chronic Pain
RecruitingPhase 2
Effectiveness of Phenotype-based Pain Management Guidelines for Head and Neck Cancer Related Pain: a Pilot Study
Cancer Pain, Orofacial Pain
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
RecruitingObservational study
Trigeminal Neuralgia Electrophysiology
Trigeminal Neuralgia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dace S Svikis, PhD principal investigator

Virginia Commonwealth University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing N-acetyl-l-cysteine in people with Neuropathic Pain, run by Virginia Commonwealth University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Opioid Use (time frame: Baseline, 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01840345.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2018.