Nicotine Metabolism and Low Nicotine Cigarettes

NCT01898507 | Completed

• 1 other identifier: 816228
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Smoking

Keywords

low nicotine; cigarettes; NMR

Outcome Measures

Primary Outcomes (1)

• Smoking topography- total puff volume

  up to 35 days

Secondary Outcomes (3)

• Daily cigarette consumption

  Study day 0, 5, 10, 15, 20, 25, 30, 35

• Urine nicotine metabolite measures

  Assessed at Days 5, 20 and 35

• Carbon monoxide measurements

  Study day 0, 5, 10, 15, 20, 25, 30, 35

Study Arms (1)

Low nicotine cigarettes

EXPERIMENTAL

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. Other: Low nicotine cigarettes

Other: Low nicotine cigarettes

Interventions

Low nicotine cigarettes OTHER

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.

Low nicotine cigarettes

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults age 21-65.
• smoking at least 10 cigarettes per day.
• smoking daily for the last 5 years.
• Provide a baseline breath CO reading equal to or greater than 10 parts per million.
• smoke predominantly non-menthol filtered cigarettes (research cigarettes are only non-menthol).
• not currently using any other nicotine containing products such as cigars, smokeless tobacco, nicotine replacement therapies (patch or gum).
• 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.

You may not qualify if:

• use of any nicotine containing products other than cigarettes
• current or impending enrollment in smoking cessation program
• history in the last year or current treatment of substance abuse (other than nicotine dependence)
• positive drug screen for cocaine, methamphetamines or opiates for urine drug screen at intake session
• alcohol use greater than 25 standard drinks per week
• current or planned pregnancy or lactating
• history or current diagnosis of psychosis, bipolar disorder, mania, or schizophrenia
• current major depression (history of major depression but in remission for a minimum 6 months is eligible).
• serious or unstable disease within past year (e.g. cancer other than melanoma, heart disease)
• history or current diagnosis of COPD
• history of stroke or heart attack
• age less than 21 years- We wish to recruit smokers with well established smoking patterns and will restrict recruitment to those over 21
• 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
• provide baseline CO reading less than 10 at initial session
• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Andrew Strasser, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: All subjects were blinded to the nicotine content of the study cigarettes.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research associate professor

Study Record Dates

• First Submitted: July 3, 2013
• First Posted: July 12, 2013
• Study Start: September 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: December 2, 2015
• Last Updated: July 18, 2018

Record last verified: 2018-07

Locations

US (1)