Project 1, Study 1: Investigating the Impact of Nicotine Using Spectrum Cigarettes (P1S1)

August 13, 2018 updated by: Wake Forest University Health Sciences
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

839

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • University of California San Francisco
    • Florida
      • Tampa, Florida, United States, 33617
        • Moffitt Cancer Center
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Johns Hopkins University
    • Minnesota
      • Duluth, Minnesota, United States, 55812
        • University of Minnesota Medical School Duluth
      • Minneapolis, Minnesota, United States, 55414
        • University of Minnesota Masonic Cancer Center
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15260
        • University of Pittsburgh
    • Rhode Island
      • Providence, Rhode Island, United States, 02912
        • Brown University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

    1. Marijuana will be tested for but will not be an exclusionary criterion.
    2. Participants with valid prescriptions for opiates, benzodiazepines, barbiturates, amphetamines or methadone will not be excluded.
    3. 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:

    1. Smoked a cigarette that was not his/her usual brand cigarette for more than one day
    2. Used any tobacco products beyond normal use for more than one day
    3. Used any nicotine replacement products or smoking cessation medications for more than one day

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 0.8 mg nicotine with 9 mg tar

very low nicotine content cigarettes

SPECTRUM Cigarette: 0.8 (±0.15) mg nicotine with 9 (±1.5) mg tar (standard nicotine and tar yields of commercially-available cigarettes; control condition)
Other: very low nicotine content cigarettes
EXPERIMENTAL: 0.26 mg nicotine with 9 mg tar

very low nicotine content cigarettes

SPECTRUM Cigarette: 0.26 (±0.06) mg nicotine with 9 (±1.5) mg tar
Other: very low nicotine content cigarettes
EXPERIMENTAL: 0.12 mg nicotine with 9 mg tar

very low nicotine content cigarettes

SPECTRUM Cigarette: 0.12 (±0.03) mg nicotine with 9 (±1.5) mg tar
Other: very low nicotine content cigarettes
EXPERIMENTAL: 0.07 mg nicotine with 9 mg tar

very low nicotine content cigarettes

SPECTRUM Cigarette: 0.07 (±0.02) mg nicotine with 9 (±1.5) mg tar
Other: very low nicotine content cigarettes
EXPERIMENTAL: 0.03 mg nicotine with 9 mg tar

very low nicotine content cigarettes

SPECTRUM Cigarette: 0.03 (±0.01) mg nicotine with 9 (±1.5) mg tar
Other: very low nicotine content cigarettes
EXPERIMENTAL: 0.04 mg nicotine with 13 mg tar

very low nicotine content cigarettes

SPECTRUM Cigarette: 0.04 (±0.02) mg nicotine with 13 (±2) mg tar
Other: very low nicotine content cigarettes
OTHER: Usual brand

very low nicotine content cigarettes

Usual brand cigarettes (control condition)
Other: very low nicotine content cigarettes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of cigarettes smoked per day
Time Frame: End of 6 week intervention
End of 6 week intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Collaborators

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

Investigators

  • Study Director: Eric C Donny, PhD, University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (ACTUAL)

July 1, 2014

Study Completion (ACTUAL)

July 1, 2014

Study Registration Dates

First Submitted

August 30, 2012

First Submitted That Met QC Criteria

September 5, 2012

First Posted (ESTIMATE)

September 10, 2012

Study Record Updates

Last Update Posted (ACTUAL)

August 15, 2018

Last Update Submitted That Met QC Criteria

August 13, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U54DA031659 (U.S. NIH Grant/Contract)
  • U54DA031659-01 (NIH)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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