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

Tobacco Dependence Clinical Trial

— P1S1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01681875
• Other study ID #: U54DA031659
• Secondary ID: U54DA031659-01
• Status: Completed
• Phase: N/A
• Start date: June 2013
• Est. completion date: July 2014

Study information

• Verified date: August 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 839
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tobacco Dependence
• Tobacco Use Disorder

Intervention

Other:
• very low nicotine content cigarettes

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	University of Minnesota Medical School Duluth	Duluth	Minnesota
United States	Duke University	Durham	North Carolina
United States	University of Minnesota Masonic Cancer Center	Minneapolis	Minnesota
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Brown University	Providence	Rhode Island
United States	University of California San Francisco	San Francisco	California
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (11)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	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, MN, University of Pennsylvania

Country where clinical trial is conducted

United States, 

References & Publications (4)

Benowitz NL, Dains KM, Hall SM, Stewart S, Wilson M, Dempsey D, Jacob P 3rd. Smoking behavior and exposure to tobacco toxicants during 6 months of smoking progressively reduced nicotine content cigarettes. Cancer Epidemiol Biomarkers Prev. 2012 May;21(5):761-9. doi: 10.1158/1055-9965.EPI-11-0644. Epub 2012 Feb 21. — View Citation

Donny EC, Houtsmuller E, Stitzer ML. Smoking in the absence of nicotine: behavioral, subjective and physiological effects over 11 days. Addiction. 2007 Feb;102(2):324-34. — View Citation

Donny EC, Jones M. Prolonged exposure to denicotinized cigarettes with or without transdermal nicotine. Drug Alcohol Depend. 2009 Sep 1;104(1-2):23-33. doi: 10.1016/j.drugalcdep.2009.01.021. Epub 2009 May 15. — View Citation

Hatsukami DK, Kotlyar M, Hertsgaard LA, Zhang Y, Carmella SG, Jensen JA, Allen SS, Shields PG, Murphy SE, Stepanov I, Hecht SS. Reduced nicotine content cigarettes: effects on toxicant exposure, dependence and cessation. Addiction. 2010 Feb;105(2):343-55. doi: 10.1111/j.1360-0443.2009.02780.x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of cigarettes smoked per day		End of 6 week intervention