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

Wake Forest University (WFU)

Status: Completed

Conditions: Tobacco Dependence

Treatments: Other: very low nicotine content cigarettes

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01681875

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

U54DA031659

Details and patient eligibility

About

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.

Enrollment: 839 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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839 participants in 7 patient groups

0.8 mg nicotine with 9 mg tar

Experimental group

Description:

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)

Treatment:

Other: very low nicotine content cigarettes

0.26 mg nicotine with 9 mg tar

Experimental group

Description:

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

Treatment:

Other: very low nicotine content cigarettes

0.12 mg nicotine with 9 mg tar

Experimental group

Description:

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

Treatment:

Other: very low nicotine content cigarettes

0.07 mg nicotine with 9 mg tar

Experimental group

Description:

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

Treatment:

Other: very low nicotine content cigarettes

0.03 mg nicotine with 9 mg tar

Experimental group

Description:

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

Treatment:

Other: very low nicotine content cigarettes

0.04 mg nicotine with 13 mg tar

Experimental group

Description:

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

Treatment:

Other: very low nicotine content cigarettes

Usual brand

Other group

Description:

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

Treatment:

Other: very low nicotine content cigarettes