Know Cancer

or
forgot password

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


N/A
18 Years
N/A
Open (Enrolling)
Both
Tobacco Dependence

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Outcome Measure:

Number of cigarettes smoked per day

Outcome Time Frame:

End of 6 week intervention

Safety Issue:

No

Principal Investigator

Eric C Donny, PhD

Investigator Role:

Study Director

Investigator Affiliation:

University of Pittsburgh

Authority:

United States: Food and Drug Administration

Study ID:

U54 DA031659

NCT ID:

NCT01681875

Start Date:

June 2013

Completion Date:

July 2014

Related Keywords:

  • Tobacco Dependence
  • Biomarkers of exposure
  • Compensatory smoking
  • Nicotine dependence
  • Reduced nicotine cigarettes
  • Tobacco withdrawal
  • Tobacco Use Disorder

Name

Location

Johns Hopkins UniversityBaltimore, Maryland  21205
University of PittsburghPittsburgh, Pennsylvania  15261
University of Minnesota Masonic Cancer CenterMinneapolis, Minnesota  55455
Brown UniversityProvidence, Rhode Island  02912