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Completed

NCT Number: NCT01681875

Project 1, Study 1: Investigating the Impact of Nicotine Using Spectrum Cigarettes

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California San Francisco, San Francisco, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Very low nicotine content cigarettes

Other

Primary outcomes

  1. Number of cigarettes smoked per day

    Time frame: End of 6 week intervention

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • Brown University
  • Duke University
  • H. Lee Moffitt Cancer Center and Research Institute
  • Johns Hopkins University
  • M.D. Anderson Cancer Center
  • Masonic Cancer Center, University of Minnesota
  • National Institute on Drug Abuse (NIDA)
  • University of California, San Francisco
  • University of Minnesota
  • University of Pennsylvania

Registry information

Acronym: P1S1

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 10, 2012
Registry last updated
Aug 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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