SurgeryPhase 1/2NCT04562597

A Pilot Trial to Determine the Effective N-acetylcysteine Dose for Opioid Reduction for Spine Surgery.

A Phase 1/2 study testing Dose Response Curve N-acetylcysteine 50 mg/kg, Dose Response Curve N-acetylcysteine 100 mg/kg and Dose Response Curve N-acetylcysteine 150 mg/kg in people with Surgery, run by Medical University of South Carolina 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

Search all trials

Trial summary

Determine the optimal dose of IV N-acetylcysteine (NAC) to produce opioid reduction following spine surgery and estimate the difference in opioid consumption between placebo and the selected optimal dose. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Surgery
What is being tested?: Dose Response Curve N-acetylcysteine 50 mg/kg, Dose Response Curve N-acetylcysteine 100 mg/kg and Dose Response Curve N-acetylcysteine 150 mg/kg
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 50 participants
Where: 1 siteUnited States
Study dates: 20 Jan 2021to 21 May 2022
Phase: Phase 1/2
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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Undergoing elective spine surgery involving 4 levels or less of the thoracic, lumbar, or sacral spine.
18 years of age and older.

Who cannot join

Less than 40kg in weight.
Unable to provide written, informed consent.
History of an adverse or anaphylactoid reaction to acetylcysteine.
Active asthma, wheezing, or using inhaled bronchodilators.
Pregnant Women
Known blood clotting deficiency

Trial locations and contacts

1 site in 1 country.

United States1 site

Medical University of South Carolina
Charleston, South Carolina, 29425

Other trials in United States

About this study

Official title: A Pilot Trial to Determine the Effective Dose of N-acetylcysteine for Opioid Reduction in Patients Undergoing Spine Surgery.

Read the detailed description

First 20 subjects: 5 participants will be randomized to each dose group (placebo, 50, 100, and 150 mg/kg) to estimate the dose response curve and to identify the optimal dose.

If the dose response curve is adequate and the optimal dose identified, 15 additional participants will be randomized to placebo and 15 to the optimal dose to estimate the difference in opioid consumption between participants on placebo vs. the optimal dose. (Total of 50 subjects with 20 from dose response curve and 30 to estimate the difference in opioid consumption.)

If the dose response curve is not adequate after the initial 20 subjects 5 per each dose group, then an additional 5 participants will be randomized and to each dose group (placebo, 50, 100, and 150 mg/kg) to estimate the dose response curve and to identify the optimal dose. Once the optimal dose is identified with these initial 40 patients, 10 additional participants will be randomized to placebo and 10 to the optimal dose to estimate the difference in opioid consumption between participants on placebo vs. the optimal dose. (60 patients total with 40 to create the dose response curve and 20 more to estimate the difference in opioid consumption.)

A sample size of 20 subjects per group (placebo and optimal dose) allows us to estimate a 95% confidence interval for the mean difference in opioid consumption with a width of + 0.64 standard deviations from the mean. 70 subjects may be enrolled to account for withdrawal but the study will be completed once 50 or 60 subjects (based on the number of subjects required to create the dose response curve) have completed the protocol.

Conditions: Surgery
Being tested: Dose Response Curve Placebo, Dose Response Curve N-acetylcysteine 50 mg/kg, Dose Response Curve N-acetylcysteine 100 mg/kg, Dose Response Curve N-acetylcysteine 150 mg/kg, Opioid Reduction with Optimal N-acetylcysteine Dose

What participants receive

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

Dose Response Curve PlaceboDrug
5 participants will be randomized to the placebo group to estimate the dose response curve and to identify the optimal dose.
Dose Response Curve N-acetylcysteine 50 mg/kgDrug
5 participants will be randomized to the N-acetylcysteine 50 mg/kg group to estimate the dose response curve and to identify the optimal dose.
Dose Response Curve N-acetylcysteine 100 mg/kgDrug
5 participants will be randomized to the N-acetylcysteine 100 mg/kg group to estimate the dose response curve and to identify the optimal dose.
Dose Response Curve N-acetylcysteine 150 mg/kgDrug
5 participants will be randomized to the N-acetylcysteine 150 mg/kg group to estimate the dose response curve and to identify the optimal dose.
Opioid Reduction with Optimal N-acetylcysteine DoseDrug
Once the optimal N-acetylcysteinedose is identified, 15 participants will be randomized to the optimal dose (50,100, or 150 mg/kg) to estimate the difference in opioid consumption between patients administered optimal N-acetylcysteine dose or placebo.
PlaceboDrug
15 Participants will be randomized to placebo to estimate the difference in opioid consumption between patients administered optimal N-acetylcysteine dose or placebo.

Study groups in NCT04562597
Study group	Role	What they receive
Dose Response Curve Placebo	Placebo comparator	5 participants will be randomized to the placebo group to estimate the dose response curve and to identify the optimal dose. Receives: Drug: Dose Response Curve Placebo
Dose Response Curve N-acetylcysteine 50 mg/kg	Active comparator	5 participants will be randomized to the N-acetylcysteine 50 mg/kg group to estimate the dose response curve and to identify the optimal dose. Receives: Drug: Dose Response Curve N-acetylcysteine 50 mg/kg
Dose Response Curve N-acetylcysteine 100 mg/kg	Active comparator	5 participants will be randomized to the N-acetylcysteine 100 mg/kg group to estimate the dose response curve and to identify the optimal dose. Receives: Drug: Dose Response Curve N-acetylcysteine 100 mg/kg
Dose Response Curve N-acetylcysteine 150 mg/kg	Active comparator	5 participants will be randomized to the N-acetylcysteine 150 mg/kg group to estimate the dose response curve and to identify the optimal dose. Receives: Drug: Dose Response Curve N-acetylcysteine 150 mg/kg
Opioid Reduction with Optimal N-acetylcysteine Dose	Active comparator	Once the optimal N-acetylcysteine dose is identified, 15 additional participants will be randomized to the optimal dose to estimate the difference in opioid consumption between patients on placebo vs. the optimal dose. Primary and secondary outcomes will only be evaluated for the placebo group and optimal NAC group. Receives: Drug: Opioid Reduction with Optimal N-acetylcysteine Dose
Placebo	Placebo comparator	15 Participants will be randomized to placebo to estimate the difference in opioid consumption between patients on placebo vs. the optimal dose. Primary and secondary outcomes will only be evaluated for the placebo group and optimal NAC group. Receives: Drug: Placebo

What is being measured

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

Opioid Consumption 12 Hours Post Operative
Post operative opioid consumption in the 12 hours that occur post-operatively.
Measured: 12 hours

Secondary outcomes (1)

Opioid Consumption Every 6 Hours Post Operative
Post operative opioid consumption ry 6 hours post operative. Data are reported as mean (95% CI) or mean difference (95% CI) estimated from a linear mixed model of opioid consumption over time including main effects for treatment group, postoperative time, and the interaction between treatment group and postoperative time and a random subject effect.
Measured: 6-48 hours

Timeline

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

20 Jan 202121 May 2022

First posted24 Sep 2020
Study start20 Jan 2021
Primary completion20 May 2022
Study completion21 May 2022

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.
Publications (23)Papers the sponsor has linked to this study.
Other trials for SurgeryStudies of the same condition, open and under way.
More trials run by Medical University of South CarolinaThe 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 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Model description: PHASE I. First 20 subjects (4 arms): We will initially randomize 5 patients to each dose group (placebo, 50, 100, and 150 mg/kg) to estimate the dose response curve and to identify the optimal dose. After enrollment of the first 20 patients, the study will undergo review by the study team and statistician. PHASE II: (2 arms) If the dose response curve is adequate and the optimal dose identified, 15 additional participants will be randomized to placebo and 15 to the optimal dose to estimate the difference in opioid consumption between patients on placebo vs. the optimal dose. Primary and secondary outcomes will be evaluated only for the placebo and optimal NAC groups.
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04562597
Sponsor's protocol ID: Pro00099062
Status last verified: Jan 2023
First submitted: 10 Sep 2020
Last updated: 14 Feb 2023
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Hall AJ, Logan JE, Toblin RL, Kaplan JA, Kraner JC, Bixler D, Crosby AE, Paulozzi LJ. Patterns of abuse among unintentional pharmaceutical overdose fatalities. JAMA. 2008 Dec 10;300(22):2613-20. doi: 10.1001/jama.2008.802.
PubMed 19066381
Pieralisi A, Martini C, Soto D, Vila MC, Calvo JC, Guerra LN. N-acetylcysteine inhibits lipid accumulation in mouse embryonic adipocytes. Redox Biol. 2016 Oct;9:39-44. doi: 10.1016/j.redox.2016.05.006. Epub 2016 May 27.
PubMed 27281491
Heim MU, Alraun K, Leeping M, Schwarzfischer G, Bock M, Kling A, Mempel W. [Incidence of the detection of erythrocyte antibodies in relation to screening test cells]. Beitr Infusionsther. 1992;30:443-5. German.
PubMed 1284756
Guo F, Li Y, Wang J, Li Y, Li Y, Li G. Stanniocalcin1 (STC1) Inhibits Cell Proliferation and Invasion of Cervical Cancer Cells. PLoS One. 2013;8(1):e53989. doi: 10.1371/journal.pone.0053989. Epub 2013 Jan 29.
PubMed 23382863
Bavarsad Shahripour R, Harrigan MR, Alexandrov AV. N-acetylcysteine (NAC) in neurological disorders: mechanisms of action and therapeutic opportunities. Brain Behav. 2014 Mar;4(2):108-22. doi: 10.1002/brb3.208. Epub 2014 Jan 13.
PubMed 24683506
Tardiolo G, Bramanti P, Mazzon E. Overview on the Effects of N-Acetylcysteine in Neurodegenerative Diseases. Molecules. 2018 Dec 13;23(12):3305. doi: 10.3390/molecules23123305.
PubMed 30551603
Monti DA, Zabrecky G, Kremens D, Liang TW, Wintering NA, Bazzan AJ, Zhong L, Bowens BK, Chervoneva I, Intenzo C, Newberg AB. N-Acetyl Cysteine Is Associated With Dopaminergic Improvement in Parkinson's Disease. Clin Pharmacol Ther. 2019 Oct;106(4):884-890. doi: 10.1002/cpt.1548. Epub 2019 Jul 17.
PubMed 31206613
Monti DA, Zabrecky G, Kremens D, Liang TW, Wintering NA, Cai J, Wei X, Bazzan AJ, Zhong L, Bowen B, Intenzo CM, Iacovitti L, Newberg AB. N-Acetyl Cysteine May Support Dopamine Neurons in Parkinson's Disease: Preliminary Clinical and Cell Line Data. PLoS One. 2016 Jun 16;11(6):e0157602. doi: 10.1371/journal.pone.0157602. eCollection 2016.
PubMed 27309537
Holmay MJ, Terpstra M, Coles LD, Mishra U, Ahlskog M, Oz G, Cloyd JC, Tuite PJ. N-Acetylcysteine boosts brain and blood glutathione in Gaucher and Parkinson diseases. Clin Neuropharmacol. 2013 Jul-Aug;36(4):103-6. doi: 10.1097/WNF.0b013e31829ae713.
PubMed 23860343
Coles LD, Tuite PJ, Oz G, Mishra UR, Kartha RV, Sullivan KM, Cloyd JC, Terpstra M. Repeated-Dose Oral N-Acetylcysteine in Parkinson's Disease: Pharmacokinetics and Effect on Brain Glutathione and Oxidative Stress. J Clin Pharmacol. 2018 Feb;58(2):158-167. doi: 10.1002/jcph.1008. Epub 2017 Sep 22.
PubMed 28940353
Halboub E, Alkadasi B, Alakhali M, AlKhairat A, Mdabesh H, Alkahsah S, Abdulrab S. N-acetylcysteine versus chlorhexidine in treatment of aphthous ulcers: a preliminary clinical trial. J Dermatolog Treat. 2021 Sep;32(6):649-653. doi: 10.1080/09546634.2019.1688231. Epub 2019 Nov 21.
PubMed 31679408
Li J, Xu L, Deng X, Jiang C, Pan C, Chen L, Han Y, Dai W, Hu L, Zhang G, Cheng Z, Liu W. N-acetyl-cysteine attenuates neuropathic pain by suppressing matrix metalloproteinases. Pain. 2016 Aug;157(8):1711-1723. doi: 10.1097/j.pain.0000000000000575.
PubMed 27075430
Notartomaso S, Scarselli P, Mascio G, Liberatore F, Mazzon E, Mammana S, Gugliandolo A, Cruccu G, Bruno V, Nicoletti F, Battaglia G. N-Acetylcysteine causes analgesia in a mouse model of painful diabetic neuropathy. Mol Pain. 2020 Jan-Dec;16:1744806920904292. doi: 10.1177/1744806920904292.
PubMed 32009537
Dludla PV, Nkambule BB, Dias SC, Johnson R. Cardioprotective potential of N-acetyl cysteine against hyperglycaemia-induced oxidative damage: a protocol for a systematic review. Syst Rev. 2017 May 12;6(1):96. doi: 10.1186/s13643-017-0493-8.
PubMed 28499416
Hoffer BJ, Pick CG, Hoffer ME, Becker RE, Chiang YH, Greig NH. Repositioning drugs for traumatic brain injury - N-acetyl cysteine and Phenserine. J Biomed Sci. 2017 Sep 9;24(1):71. doi: 10.1186/s12929-017-0377-1.
PubMed 28886718

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?

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Study at a glance

From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Trial to Determine the Effective Dose of N-acetylcysteine for Opioid Reduction in Patients Undergoing Spine Surgery.
ClinicalTrials.gov ID: NCT04562597
Acronym / sponsor ID: Pro00099062
Conditions: Surgery
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Medical University of South CarolinaUniversity, hospital or other
Study start: 20 Jan 2021 (actual)
Primary completion: 20 May 2022 (actual)
Study completion: 21 May 2022 (actual)
First posted: 24 Sep 2020 (actual)
Results: Posted 14 Feb 2023

Clinical summary

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

Detailed description

First 20 subjects: 5 participants will be randomized to each dose group (placebo, 50, 100, and 150 mg/kg) to estimate the dose response curve and to identify the optimal dose.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 6
Model description: PHASE I. First 20 subjects (4 arms): We will initially randomize 5 patients to each dose group (placebo, 50, 100, and 150 mg/kg) to estimate the dose response curve and to identify the optimal dose. After enrollment of the first 20 patients, the study will undergo review by the study team and statistician. PHASE II: (2 arms) If the dose response curve is adequate and the optimal dose identified, 15 additional participants will be randomized to placebo and 15 to the optimal dose to estimate the difference in opioid consumption between patients on placebo vs. the optimal dose. Primary and secondary outcomes will be evaluated only for the placebo and optimal NAC groups.

Arm	Type	Receives
Dose Response Curve Placebo	Placebo comparator	Drug: Dose Response Curve Placebo5 participants will be randomized to the placebo group to estimate the dose response curve and to identify the optimal dose.
Dose Response Curve N-acetylcysteine 50 mg/kg	Active comparator	Drug: Dose Response Curve N-acetylcysteine 50 mg/kg5 participants will be randomized to the N-acetylcysteine 50 mg/kg group to estimate the dose response curve and to identify the optimal dose.
Dose Response Curve N-acetylcysteine 100 mg/kg	Active comparator	Drug: Dose Response Curve N-acetylcysteine 100 mg/kg5 participants will be randomized to the N-acetylcysteine 100 mg/kg group to estimate the dose response curve and to identify the optimal dose.
Dose Response Curve N-acetylcysteine 150 mg/kg	Active comparator	Drug: Dose Response Curve N-acetylcysteine 150 mg/kg5 participants will be randomized to the N-acetylcysteine 150 mg/kg group to estimate the dose response curve and to identify the optimal dose.
Opioid Reduction with Optimal N-acetylcysteine Dose	Active comparator	Drug: Opioid Reduction with Optimal N-acetylcysteine DoseOnce the optimal N-acetylcysteine dose is identified, 15 additional participants will be randomized to the optimal dose to estimate the difference in opioid consumption between patients on placebo vs. the optimal dose. Primary and secondary outcomes will only be evaluated for the placebo group and optimal NAC group.
Placebo	Placebo comparator	Drug: Placebo15 Participants will be randomized to placebo to estimate the difference in opioid consumption between patients on placebo vs. the optimal dose. Primary and secondary outcomes will only be evaluated for the placebo group and optimal NAC group.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Undergoing elective spine surgery involving 4 levels or less of the thoracic, lumbar, or sacral spine.
18 years of age and older.

Key exclusion criteria (6 listed)

Less than 40kg in weight.
Unable to provide written, informed consent.
History of an adverse or anaphylactoid reaction to acetylcysteine.
Active asthma, wheezing, or using inhaled bronchodilators.
Pregnant Women

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
Dose Response Curve Placebo5 participants will be randomized to the placebo group to estimate the dose response curve and to identify the optimal dose.	Drug	Dose Response Curve Placebo
Dose Response Curve N-acetylcysteine 50 mg/kg5 participants will be randomized to the N-acetylcysteine 50 mg/kg group to estimate the dose response curve and to identify the optimal dose.	Drug	Dose Response Curve N-acetylcysteine 50 mg/kg
Dose Response Curve N-acetylcysteine 100 mg/kg5 participants will be randomized to the N-acetylcysteine 100 mg/kg group to estimate the dose response curve and to identify the optimal dose.	Drug	Dose Response Curve N-acetylcysteine 100 mg/kg
Dose Response Curve N-acetylcysteine 150 mg/kg5 participants will be randomized to the N-acetylcysteine 150 mg/kg group to estimate the dose response curve and to identify the optimal dose.	Drug	Dose Response Curve N-acetylcysteine 150 mg/kg
Opioid Reduction with Optimal N-acetylcysteine DoseOnce the optimal N-acetylcysteinedose is identified, 15 participants will be randomized to the optimal dose (50,100, or 150 mg/kg) to estimate the difference in opioid consumption between patients administered optimal N-acetylcysteine dose or placebo.	Drug	Opioid Reduction with Optimal N-acetylcysteine Dose
Placebo15 Participants will be randomized to placebo to estimate the difference in opioid consumption between patients administered optimal N-acetylcysteine dose or placebo.	Drug	Placebo

Primary outcome

Opioid Consumption 12 Hours Post Operative
Time frame: 12 hours
Post operative opioid consumption in the 12 hours that occur post-operatively.

1 secondary outcome

Opioid Consumption Every 6 Hours Post Operative
Time frame: 6-48 hours

Results and safety

Results posted to the registry on 14 Feb 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Period 1: NAC (0mg/kg)	5	5
Period 1: NAC (50mg/kg)	5	5
Period 1: NAC (100mg/kg)	5	5
Period 1: NAC (150mg/kg)	5	5
Period 2: NAC (0mg/kg)	15	15
Period 2: NAC (150mg/kg)	15	15

Primary outcome: Opioid Consumption 12 Hours Post Operative

Time frame: 12 hours. Mean (95% Confidence Interval). Unit: IV morphine mg equivalents

Measure	Placebo n = 20	N-acetylcysteine (NAC) n = 20
Value	19.4 (10.8 to 28)	15.6 (7.02 to 24.2)

Population analysed: Primary and secondary outcomes were only be evaluated for the placebo and optimal NAC groups. Data are reported as mean (95% CI) estimated from a linear mixed model of opioid consumption over time including main effects for treatment group, postoperative time, and the interaction between treatment group and postoperative time and a random subject effect.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 48 hours. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 20 (0%)	0 of 20 (0%)	0 of 20
NAC 50 mg/kg	0 of 5 (0%)	0 of 5 (0%)	0 of 5
NAC 100 mg/kg	0 of 5 (0%)	0 of 5 (0%)	0 of 5
NAC 150 mg/kg	0 of 20 (0%)	0 of 20 (0%)	0 of 20

Limitations and caveats (from the sponsor): * Opioid consumption was highly variable. This is likely due to the small sample size. * Data only collected up to 48 hours postoperative, and this limits our ability to comment more on the usefulness of NAC as an agent for patients with chronic pain.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 19066381Hall AJ, Logan JE, Toblin RL, Kaplan JA, Kraner JC, Bixler D, Crosby AE, Paulozzi LJ. Patterns of abuse among unintentional pharmaceutical overdose fatalities. JAMA. 2008 Dec 10;300(22):2613-20. doi: 10.1001/jama.2008.802.
Background: PubMed 27281491Pieralisi A, Martini C, Soto D, Vila MC, Calvo JC, Guerra LN. N-acetylcysteine inhibits lipid accumulation in mouse embryonic adipocytes. Redox Biol. 2016 Oct;9:39-44. doi: 10.1016/j.redox.2016.05.006. Epub 2016 May 27.
Background: PubMed 1284756Heim MU, Alraun K, Leeping M, Schwarzfischer G, Bock M, Kling A, Mempel W. [Incidence of the detection of erythrocyte antibodies in relation to screening test cells]. Beitr Infusionsther. 1992;30:443-5. German.
Background: PubMed 23382863Guo F, Li Y, Wang J, Li Y, Li Y, Li G. Stanniocalcin1 (STC1) Inhibits Cell Proliferation and Invasion of Cervical Cancer Cells. PLoS One. 2013;8(1):e53989. doi: 10.1371/journal.pone.0053989. Epub 2013 Jan 29.
Background: PubMed 24683506Bavarsad Shahripour R, Harrigan MR, Alexandrov AV. N-acetylcysteine (NAC) in neurological disorders: mechanisms of action and therapeutic opportunities. Brain Behav. 2014 Mar;4(2):108-22. doi: 10.1002/brb3.208. Epub 2014 Jan 13.
Background: PubMed 30551603Tardiolo G, Bramanti P, Mazzon E. Overview on the Effects of N-Acetylcysteine in Neurodegenerative Diseases. Molecules. 2018 Dec 13;23(12):3305. doi: 10.3390/molecules23123305.
Background: PubMed 31206613Monti DA, Zabrecky G, Kremens D, Liang TW, Wintering NA, Bazzan AJ, Zhong L, Bowens BK, Chervoneva I, Intenzo C, Newberg AB. N-Acetyl Cysteine Is Associated With Dopaminergic Improvement in Parkinson's Disease. Clin Pharmacol Ther. 2019 Oct;106(4):884-890. doi: 10.1002/cpt.1548. Epub 2019 Jul 17.
Background: PubMed 27309537Monti DA, Zabrecky G, Kremens D, Liang TW, Wintering NA, Cai J, Wei X, Bazzan AJ, Zhong L, Bowen B, Intenzo CM, Iacovitti L, Newberg AB. N-Acetyl Cysteine May Support Dopamine Neurons in Parkinson's Disease: Preliminary Clinical and Cell Line Data. PLoS One. 2016 Jun 16;11(6):e0157602. doi: 10.1371/journal.pone.0157602. eCollection 2016.
Background: PubMed 23860343Holmay MJ, Terpstra M, Coles LD, Mishra U, Ahlskog M, Oz G, Cloyd JC, Tuite PJ. N-Acetylcysteine boosts brain and blood glutathione in Gaucher and Parkinson diseases. Clin Neuropharmacol. 2013 Jul-Aug;36(4):103-6. doi: 10.1097/WNF.0b013e31829ae713.
Background: PubMed 28940353Coles LD, Tuite PJ, Oz G, Mishra UR, Kartha RV, Sullivan KM, Cloyd JC, Terpstra M. Repeated-Dose Oral N-Acetylcysteine in Parkinson's Disease: Pharmacokinetics and Effect on Brain Glutathione and Oxidative Stress. J Clin Pharmacol. 2018 Feb;58(2):158-167. doi: 10.1002/jcph.1008. Epub 2017 Sep 22.
Background: PubMed 31679408Halboub E, Alkadasi B, Alakhali M, AlKhairat A, Mdabesh H, Alkahsah S, Abdulrab S. N-acetylcysteine versus chlorhexidine in treatment of aphthous ulcers: a preliminary clinical trial. J Dermatolog Treat. 2021 Sep;32(6):649-653. doi: 10.1080/09546634.2019.1688231. Epub 2019 Nov 21.
Background: PubMed 27075430Li J, Xu L, Deng X, Jiang C, Pan C, Chen L, Han Y, Dai W, Hu L, Zhang G, Cheng Z, Liu W. N-acetyl-cysteine attenuates neuropathic pain by suppressing matrix metalloproteinases. Pain. 2016 Aug;157(8):1711-1723. doi: 10.1097/j.pain.0000000000000575.
Individual participant dataSharing planned: No

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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.

Sylvia Wilson, MD principal investigator

Medical University of South Carolina

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

Questions about this trial

What is this clinical trial studying?

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 2 inclusion and 6 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 Feb 2023. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 Feb 2023). 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 Consumption 12 Hours Post Operative (time frame: 12 hours). 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 NCT04562597, which also lists 23 linked publications.

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 Feb 2023.