CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 245 enrolled
Drug / intervention
Reduced Nicotine Content Cigarettes +1 moredrug
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/NCT01928758
NCT01928758N/ACompleted

Reduced Nicotine Cigarettes in Smokers With Mood and Anxiety Disorders

Milton S. Hershey Medical Center·interventional·Posted Aug 27, 2013·Updated Jun 28, 2019

In Brief

A clinical study evaluating Reduced Nicotine Content Cigarettes and Usual Nicotine Content Cigarettes for Tobacco Dependence. Completed, enrolled 245 participants across 2 sites.

Detailed Summary

The overall aim of this project is to evaluate the effect of progressive nicotine reduction in cigarettes on smoking behavior, toxin exposure and psychiatric symptoms in smokers with comorbid mood and/or anxiety disorders. Smokers with mood and/or anxiety disorder will smoke research cigarettes that will contain either a) nicotine content similar to their preferred usual brand of cigarettes, or b) nicotine content per cigarette that is progressively reduced from approximately 11.6 mg to 0.2 mg per cigarette over 18 weeks. It is our hypothesis that nicotine intake will decline as a function of cigarette nicotine content in the Reduced Nicotine Content group without significant increases in tobacco smoke exposure, severity of nicotine withdrawal symptoms, mood and anxiety symptomatology or protocol non-adherence over time in the Reduced Nicotine Content group as compared with the control group.

Study Details

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

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedAug 27, 2013
Enrollment StartSep 1, 2015
Primary CompletionJan 11, 2018
Study CompletionMar 23, 2018
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 12.8 years ago

Interventions

Reduced Nicotine Content Cigarettesdrug

Research cigarettes will have gradually reduced nicotine content

Usual Nicotine Content Cigarettesdrug

Usual Nicotine Content Cigarettes