CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 67 enrolled
Drug / intervention
Nicotine Replacement Therapy (NRT) +3 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01314443
NCT01314443Phase 2Completed

Cardioprotective Synergy of Smoking Cessation and γ-Tocopherol in Restoring Vascular Endothelial Function

University of Connecticut·interventional·Posted Mar 14, 2011·Updated Jan 21, 2015

In Brief

A Phase 2 clinical trial evaluating Nicotine Replacement Therapy (NRT), Gamma-Tocopherol, and 2 other interventions for Endothelial Dysfunction. Completed, enrolled 67 participants across 1 site.

Detailed Summary

Cigarette smoking is a significant risk factor for cardiovascular disease (CVD) and is the leading cause of premature mortality in the US. The detrimental effects of smoking on vascular dysfunction are attributed to the effects of smoke itself and the inflammatory responses it induces. Smoking cessation restores vascular function by alleviating these stress responses. However, smoking cessation with nicotine replacement therapy (NRT), the prevailing approach to mitigate tobacco dependence, fails to allow full restoration of vascular function. Thus, a critical public health problem exists to understand how NRT prevents restoration of vascular function and how these NRT-mediated impairments can be overcome by using gamma-tocopherol (g-T) as an innovative co-therapy. The objective of this study is to conduct a clinical intervention trial that aims to reduce CVD risk by defining how smoking cessation and g-T restore vascular function. The hypothesis is that smoking cessation and dietary g-T supplementation will synergistically restore smoking-induced impairments in vascular function by ameliorating oxidative/nitrosative stress responses, and that g-T will facilitate full restoration of vascular function otherwise precluded by NRT. A placebo-controlled, g-T intervention study will be conducted in cigarette smokers undergoing nicotine-free or NRT smoking cessation. Prior to and after 24 h and 7 days of placebo or g-T administration, vascular function will be evaluated using a non-invasive ultrasound technique and an array of antioxidants and biomarkers for vascular inflammation and oxidative/nitrosative stress responses will be assessed. Collectively, these studies will help identify how vascular function is regulated in individuals undergoing smoking cessation, and whether g-T can be used as a strategy to better improve vascular function during smoking cessation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 14, 2011
Enrollment StartJan 1, 2011
Primary CompletionNov 1, 2011
Study CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 15.3 years ago

Interventions

Nicotine Replacement Therapy (NRT)other

Participants will quit smoking with nicotine patches

Gamma-Tocopheroldietary

Participants will take gamma-tocopherol (500 mg/d) supplements for 7 days

Placeboother

Participants will take placebo for 7 days

Smoking cessationbehavioral

Participants will quit smoking without any pharmacological aids