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

Not Applicable

Completed

• Conditions: Tobacco Dependence
• Interventions: Other: very low nicotine content cigarettes

• Registration Number: NCT01681875
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-08-30
• Study First Submitted QC: 2012-09-05
• Study First Posted: 2012-09-10
• Study Start: 2013-06
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-13
• Last Update Posted: 2018-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 839

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.03 mg nicotine with 9 mg tar	very low nicotine content cigarettes	very low nicotine content cigarettes SPECTRUM Cigarette: 0.03 (±0.01) mg nicotine with 9 (±1.5) mg tar
0.26 mg nicotine with 9 mg tar	very low nicotine content cigarettes	very low nicotine content cigarettes SPECTRUM Cigarette: 0.26 (±0.06) mg nicotine with 9 (±1.5) mg tar
0.12 mg nicotine with 9 mg tar	very low nicotine content cigarettes	very low nicotine content cigarettes SPECTRUM Cigarette: 0.12 (±0.03) mg nicotine with 9 (±1.5) mg tar
0.04 mg nicotine with 13 mg tar	very low nicotine content cigarettes	very low nicotine content cigarettes SPECTRUM Cigarette: 0.04 (±0.02) mg nicotine with 13 (±2) mg tar
Usual brand	very low nicotine content cigarettes	very low nicotine content cigarettes Usual brand cigarettes (control condition)
0.8 mg nicotine with 9 mg tar	very low nicotine content cigarettes	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)
0.07 mg nicotine with 9 mg tar	very low nicotine content cigarettes	very low nicotine content cigarettes SPECTRUM Cigarette: 0.07 (±0.02) mg nicotine with 9 (±1.5) mg tar

Primary Outcome Measures

Name	Time	Method
Number of cigarettes smoked per day	End of 6 week intervention

Trial Locations

Locations (9)

University of Minnesota Medical School Duluth; 🇺🇸 Duluth, Minnesota, United States

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States

University of California San Francisco; 🇺🇸 San Francisco, California, United States

University of Minnesota Masonic Cancer Center; 🇺🇸 Minneapolis, Minnesota, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Brown University; 🇺🇸 Providence, Rhode Island, United States

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

Duke University; 🇺🇸 Durham, North Carolina, United States