NCT00879918

Brief Summary

The investigators hypothesize that African Americans (AAs) smoke more for positive reinforcement from nicotine with a "peak-seeking" pattern of smoking (smoking individual cigarettes more intensively with greater intake of nicotine and tobacco smoke toxins), while whites smoke more for negative reinforcement with a "trough-maintaining" pattern (avoiding withdrawal by maintaining more consistent nicotine levels throughout the day by means of a more regular smoking pattern). The investigators believe that these patterns are linked to identifiable racial differences in nicotine pharmacology and that there will be associated racial differences in responses to pharmacologic interventions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Dec 2008

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 13, 2009

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

May 24, 2013

Status Verified

May 1, 2013

Enrollment Period

3.2 years

First QC Date

April 9, 2009

Last Update Submit

May 23, 2013

Conditions

Cigarette Smoking

Keywords

Cigarette Smoking in African Americans

Outcome Measures

Primary Outcomes (1)

  • Nicotine clearance

    10 days

Study Arms (1)

Nicotine pharmacokinetics

EXPERIMENTAL

circadian smoking protocol and IV pharmacokinetic protocol

Drug: Deuterated nicotine and cotinine

Interventions

Deuterated nicotine and cotinineDRUG

used as a marker for pharmacokinetic studies

Nicotine pharmacokinetics

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • African-American
  • Age 18-65
  • Smoke at least 5 cigarettes per day

You may not qualify if:

  • Significant health conditions
  • Drug use
  • Pregnancy or breastfeeding
  • Inability to read English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California San Francisco/SFGH

San Francisco, California, 94110, United States

Location

MeSH Terms

Conditions

Cigarette Smoking

Interventions

Cotinine

Condition Hierarchy (Ancestors)

Tobacco SmokingSmokingBehaviorTobacco Use

Intervention Hierarchy (Ancestors)

PyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Neal L Benowitz, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2009

First Posted

April 13, 2009

Study Start

December 1, 2008

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

May 24, 2013

Record last verified: 2013-05

Locations

US(1)