Nicotine Metabolism and Little Cigars

NCT01898559 | Completed

• 1 other identifier: 816605
• Study Type: interventional
• Target: 197
• Locations: 1 country
• Sites: 1

Brief Summary

This study examines the effects of smoking little cigars 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 when they switch to smoking cigars instead of cigarettes.

Conditions

Smoking

Keywords

little cigars; cigarettes; smoking

Outcome Measures

Primary Outcomes (1)

• Number of cigars consumed daily

  The number of cigars smoked each day.

  20 days

Secondary Outcomes (2)

• Carbon monoxide measurements

  Each study day 0, 5, 10, 15, 20

• Nicotine metabolites from urine samples

  20 days

Study Arms (2)

Black & Mild little cigars

EXPERIMENTAL

Participants switch from smoking their own brand of cigarettes to only smoking Black \& Mild little cigars. Other: Switch to smoking only little cigars

Other: Switch to smoking only little cigars

King Edward little cigars

EXPERIMENTAL

Participants switch from smoking their own brand of cigarettes to only smoking King Edward little cigars. Other: Switch to smoking only little cigars

Other: Switch to smoking only little cigars

Interventions

Switch to smoking only little cigars OTHER

Participants smoke only little cigars for 15 days.

Black & Mild little cigars; King Edward little cigars

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 10 parts per million.
• smoke predominantly filtered cigarettes.
• not currently using any other nicotine containing products such as 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.
• Have smoked at least 25 cigars in their lifetime

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 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- participants must be 21 years old to give consent to volunteer
• 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: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2013
• First Posted: July 12, 2013
• Study Start: December 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: September 1, 2017
• Last Updated: October 6, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)