P1S1Project 1, Study 1: Investigating the Impact of Nicotine Using Spectrum Cigarettes
very low nicotine content cigarettes
+ very low nicotine content cigarettes
+ very low nicotine content cigarettes
Mental Disorders+1
+ Substance-Related Disorders
+ Chemically-Induced Disorders
Basic Science Study
Summary
Study start date: June 1, 2013
Actual date on which the first participant was enrolled.Project 1, Study 1 will evaluate the relationship between nicotine yield of very low nicotine content cigarettes and cigarettes smoked per day, nicotine exposure, discomfort/dysfunction, other health-related behaviors, nicotine/tobacco dependence, biomarkers of tobacco exposure, intention to quit, compensatory smoking, other tobacco use, cigarette characteristics, cognitive function, cardiovascular function, and perceived risk. We will also consider differences between conditions in compliance with product use.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.839 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Basic Science Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: Age 18+ Smoke an average of at least five cigarettes per day for at least 1 year Breath CO levels > 8 ppm (if ≤ 8 ppm, then NicAlert Strip > 2) Exclusion Criteria: Intention to quit smoking in the next 30 days Currently seeking treatment for smoking cessation Currently using nicotine replacement therapies or other pharmacotherapies as cessation aid (intermittent use acceptable) A quit attempt in the past 30 days resulting in greater than 3 days of abstinence Using other tobacco products more than 9 days in the past 30 days Significant unstable medical conditions (Any significant change in a serious medical condition occurring during the past 3 months including, cardiovascular disease, COPD, and cancer, as determined by the licensed medical professional at each site) Significant unstable psychiatric conditions (Any significant change in psychiatric symptoms during the past 3 months as determined by the licensed medical professional at each site) Schizophrenia and schizoaffective disorder Psychiatric medication changes in the past 3 months Positive toxicology screen for any of the following drugs: cocaine, opiates, methadone, benzodiazepines, barbiturates, amphetamines, methamphetamines, and PCP Marijuana will be tested for but will not be an exclusionary criterion. Participants with valid prescriptions for opiates, benzodiazepines, barbiturates, amphetamines or methadone will not be excluded. Participants failing the toxicology screen will be allowed to re-screen once. Blood alcohol level > 0.01 a. Participants failing the blood alcohol screen will be allowed to re-screen once. Binge drinking alcohol (more than 9 days in the past 30 days, 4/5 in a 2 hour period(female/male)) Pregnant or breastfeeding Smoking 'roll your own cigarettes' exclusively Currently taking anticonvulsant medication CO reading >80 ppm Systolic BP greater than or equal to 160 a. Participants failing for blood pressure will be allowed to re-screen once. Diastolic BP greater than or equal to 100 a. Participants failing for blood pressure will be allowed to re-screen once. Systolic BP below 90 a. Participants failing for blood pressure will be allowed to re-screen once. Diastolic BP below 50 a. Participants failing for blood pressure will be allowed to re-screen once. Heart rate greater than or equal to 115bpm a. Participants failing for heart rate will be allowed to re-screen once. Heart rate lower than 45bpm a. Participants failing for heart rate will be allowed to re-screen once. Indicating any suicidal ideation in the past month or suicide attempts in the past 10 years Inability to independently read and comprehend the consent form and other written study materials and measures Having participated in a research study during the past three months in which the participant: Smoked a cigarette that was not his/her usual brand cigarette for more than one day Used any tobacco products beyond normal use for more than one day Used any nicotine replacement products or smoking cessation medications for more than one day
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.7 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
ExperimentalGroup IV
ExperimentalGroup 5
ExperimentalGroup 6
ExperimentalGroup 7
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 9 locations
University of California San Francisco
San Francisco, United StatesOpen University of California San Francisco in Google MapsMoffitt Cancer Center
Tampa, United StatesJohns Hopkins University
Baltimore, United StatesUniversity of Minnesota Medical School Duluth
Duluth, United States