Vascular Endothelial Protection Effects of Dextromethorphan

Anti-Inflammation & Vascular Endothelial Protection Effects of Dextromethorphan on Heavy Smoker

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00605605

Enrollment

Registered

2008-01-31

Start date

2005-03-31

Completion date

2005-12-31

Last updated

2008-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis, Inflammation, Smoking

Keywords

endothelial function, atherosclerosis, smoking, inflammation, antioxidant

Brief summary

To test the hypothesis that DM could have anti-inflammatory effect and thus achieve vascular protection effect on heavy smokers.

Detailed description

Dextromethorphan (DM), an ingredient widely used in antitussive remedies, had been reported to reduce the inflammation-mediated degeneration of neurons. We recently found that DM can prevent vascular remodeling and neuron injury in animal models of carotid ligation and cerebral ischemia injuries, respectively. It was believed that its action was through the anti-oxidant and NADPH pathway to protect brain cells. However, the mechanism and actual effect on human vascular protection remained unclear. To test the hypothesis that DM could have anti-inflammatory effect and thus achieve vascular protection effect on heavy smokers, this prospective study will be conducted to treat subjects with heavy smoking history with DM or not and evaluate the anti-inflammatory and the improvement of endothelial function.

Interventions

DRUGDextromethorphan

120 mg/day, single once daily dose taken after breakfast by oral route

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

30 Years to 60 Years

Healthy volunteers

Inclusion criteria

* healthy male volunteers who are currently smoking

Exclusion criteria

* personal history of hypertension or diabetes mellitus * family history with * documented premature cardiovascular events * cardiovascular-associated sudden death * total cholesterol \> 240 mg/dL * triglyceride \> 200 mg/dL * low-density lipoprotein \> 160 mg/dL.

Design outcomes

Primary

Measure	Time frame
Endothelial function	1, 2, 3 and 6 month

Secondary

Measure	Time frame
Surrogate end-points of the study: hs-CRP, sPLA2, matrix metalloproteinase-3, interleukin-6, tumor necrosis factor-alfa receptor II, GSH-Px, and urinary excretion of 8-PGF2alfa	1, 2, 3 and 6 months

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026