Nicotine Metabolism and Low Nicotine Cigarettes

Smoking Clinical Trial

Official title:

Nicotine Metabolism and Low Nicotine Cigarettes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01898507
• Other study ID #: 816228
• Status: Completed
• Phase: N/A
• Start date: September 2013
• Est. completion date: December 2, 2015

Study information

• Verified date: July 2018
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study examines the effects of smoking low nicotine cigarettes in different groups of smokers. The investigators are focusing on differences in how smokers' bodies break down and eliminate nicotine from their systems. Some people are fast metabolizers of nicotine, meaning they break down and eliminate nicotine from their bodies more quickly. Other people are slower metabolizers meaning they break down and eliminate nicotine more slowly. The investigators are comparing these two groups of smokers for their responses to low nicotine cigarettes. The investigators hypothesize that individuals who smoke low nicotine cigarettes may smoke more intensely or smoke more each day, thereby maintaining their desired nicotine levels, and as a result continue to be exposed to significant toxin levels.

Description:

This study examines the effects of smoking low nicotine cigarettes on smoking behaviors and toxin exposure in fast and slow nicotine metabolizing smokers. We will recruit current smokers (split between slow and rapid nicotine metabolizing smokers) for a 35-day protocol. Participants will smoke their own brand cigarettes during a baseline 5 day period, followed by a 15-day period of smoking low nicotine content cigarette level 1: 0.25 mg nicotine content, followed by a 15-day period of smoking low nicotine content cigarette level 2: 0.08 mg nicotine content. This application is designed to provide empirical science to inform the FDA on the effect smoking low nicotine content cigarettes will have on use patterns and harm exposure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: December 2, 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criteria:

1. adults age 21-65.

2. smoking at least 10 cigarettes per day.

3. smoking daily for the last 5 years.

4. Provide a baseline breath CO reading equal to or greater than 10 parts per million.

5. smoke predominantly non-menthol filtered cigarettes (research cigarettes are only non-menthol).

6. not currently using any other nicotine containing products such as cigars, smokeless tobacco, nicotine replacement therapies (patch or gum).

7. are fluent in English and are capable of providing written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form.

Participants who meet the inclusion/exclusion criteria and attend an Intake Visit for medical screening will be asked to provide a blood sample to determine NMR. Only those individuals who are characterized as slow or rapid, based on NMRs = .26, or = .42, will be eligible.

Exclusion Criteria:

1. use of any nicotine containing products other than cigarettes

2. current or impending enrollment in smoking cessation program

3. history in the last year or current treatment of substance abuse (other than nicotine dependence)

4. positive drug screen for cocaine, methamphetamines or opiates for urine drug screen at intake session

5. alcohol use greater than 25 standard drinks per week

6. current or planned pregnancy or lactating

7. history or current diagnosis of psychosis, bipolar disorder, mania, or schizophrenia

8. current major depression (history of major depression but in remission for a minimum 6 months is eligible).

9. serious or unstable disease within past year (e.g. cancer other than melanoma, heart disease)

10. history or current diagnosis of COPD

11. history of stroke or heart attack

12. age less than 21 years- We wish to recruit smokers with well established smoking patterns and will restrict recruitment to those over 21

13. age more than 65 years - smoking is often associated with cardiovascular and pulmonary obstructive diseases that manifest later in life. As smokers develop these problems, smoking behavior and biomarkers of harm may be affected therefore we will restrict enrollment to those under age 65

14. provide baseline CO reading less than 10 at initial session

15. current use (or use within past 14 days) of any medication that affects the biotransformation of nicotine, such as anticonvulsant drugs, rifampin, and disulfiram; or any psychoactive medications which can affect smoking behaviors

16. any conditions viewed by the PI or study physician as creating a potential increased risk to a participant due to their participation will be reasons for exclusion

17. at the discretion of the PI, any participants viewed as non-compliant will be excluded from further participation

18. Smoke cigarettes with a filter size other than standard or slim sized as the topography mouthpieces are sized for standard filters and have an adapter for slim cigarettes only.

Related Conditions & MeSH terms

• Smoking

Intervention

Other:
• Low nicotine cigarettes
15-day period of smoking low nicotine content cigarette level 1: 0.25 mg nicotine content, followed by a 15-day period of smoking low nicotine content cigarette level 2: 0.08 mg nicotine content.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking topography- total puff volume		up to 35 days
Secondary	Daily cigarette consumption	Total number of cigarettes smoked each day.	Study day 0, 5, 10, 15, 20, 25, 30, 35
Secondary	Urine nicotine metabolite measures	NNK, mercapturic acid metabolites, total nicotine equivalents	Assessed at Days 5, 20 and 35
Secondary	Carbon monoxide measurements		Study day 0, 5, 10, 15, 20, 25, 30, 35