Project 1, Study 1: Investigating the Impact of Nicotine Using Spectrum Cigarettes (P1S1)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Tobacco Dependence |
Other: very low nicotine content cigarettes |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Basic Science |
| Official Title: | Project 1, Study 1: Investigating the Impact of Nicotine Using Spectrum Cigarettes |
- Number of cigarettes smoked per day [ Time Frame: End of 6 week intervention ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 840 |
| Study Start Date: | June 2013 |
| Estimated Study Completion Date: | July 2014 |
| Estimated Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 0.8 mg nicotine with 8 mg tar
very low nicotine content cigarettes SPECTRUM Cigarette: 0.8 (±0.15) mg nicotine with 8 (±1.5) mg tar (standard nicotine and tar yields of commercially-available cigarettes; control condition) |
Other: very low nicotine content cigarettes |
|
Experimental: 0.25 mg nicotine with 8 mg tar
very low nicotine content cigarettes SPECTRUM Cigarette: 0.25 (±0.05) mg nicotine with 8 (±1.5) mg tar |
Other: very low nicotine content cigarettes |
|
Experimental: 0.13 mg nicotine with 8 mg tar
very low nicotine content cigarettes SPECTRUM Cigarette: 0.13 (±0.03) mg nicotine with 8 (±1.5) mg tar |
Other: very low nicotine content cigarettes |
|
Experimental: 0.07 mg nicotine with 8 mg tar
very low nicotine content cigarettes SPECTRUM Cigarette: 0.07 (±0.03) mg nicotine with 8 (±1.5) mg tar |
Other: very low nicotine content cigarettes |
|
Experimental: 0.03 mg nicotine with 8 mg tar
very low nicotine content cigarettes SPECTRUM Cigarette: 0.03 (±0.03) mg nicotine with 8 (±1.5) mg tar |
Other: very low nicotine content cigarettes |
|
Experimental: 0.03 mg nicotine with 12.5 mg tar
very low nicotine content cigarettes SPECTRUM Cigarette: 0.03 (±0.03) mg nicotine with 12.5 (±1.5) mg tar |
Other: very low nicotine content cigarettes |
|
Usual brand
very low nicotine content cigarettes Usual brand cigarettes (control condition) |
Other: very low nicotine content cigarettes |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
- Marijuana will be tested for but will not be an exclusionary criterion.
- Participants with valid prescriptions for opiates, benzodiazepines, barbiturates, amphetamines or methadone will not be excluded.
- 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 and symptomatic
a. Participants failing for blood pressure will be allowed to re-screen once.
Diastolic BP below 50 and symptomatic
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 and symptomatic
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:
- Smoked a cigarette that was not his/her usual brand cigarette for more than one day
- Used any tobacco products beyond normal use for more than one day
- Used any nicotine replacement products or smoking cessation medications for more than one day
Contacts and Locations| Contact: Rachel L Denlinger, B.S | 412-624-7865 | rld9@pitt.edu |
| Contact: Tonya Lane, M.Ed. | 412-624-6179 | tjd50@pitt.edu |
| United States, Pennsylvania | |
| University of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15260 | |
| Study Director: | Eric C Donny, PhD | University of Pittsburgh |
More Information
Publications:
| Responsible Party: | University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT01681875 History of Changes |
| Other Study ID Numbers: | U54 DA031659, U54DA031659-01 |
| Study First Received: | August 30, 2012 |
| Last Updated: | May 2, 2013 |
| Health Authority: | United States: Food and Drug Administration United States: Data and Safety Monitoring Board |
Keywords provided by University of Pittsburgh:
|
Biomarkers of exposure Compensatory smoking Nicotine dependence Reduced nicotine cigarettes Tobacco withdrawal |
Additional relevant MeSH terms:
|
Tobacco Use Disorder Substance-Related Disorders Mental Disorders Nicotine Nicotine polacrilex Ganglionic Stimulants Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Pharmacologic Actions Nicotinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013