AzTrials
AzTrials

Cigarette SmokingPhase 15075-AAPK1NCT00879918

Pharmacogenetics of Nicotine Metabolism in African-Americans

A Phase 1 study testing Deuterated nicotine and cotinine in people with Cigarette Smoking, run by University of California, San Francisco at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Cigarette Smoking
What is being tested?
Deuterated nicotine and cotinine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteUnited States
Study dates
Dec 2008to Mar 2012
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of California San Francisco/SFGH

    San Francisco, California, 94110

Other trials in United States

About this study

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.

Read the detailed description

Smoking is the major preventable cause of cancer, premature cardiovascular disease and chronic obstructive lung disease, reproductive problems and infections. AA smokers have a substantially higher risk of cancer and reproductive disorders compared to whites. A recently published large cohort study (183,000 subjects) found a two-fold higher incidence of lung cancer in AAs compared to whites (at cigarette consumption levels of <10 and 11-20 CPD, but not for >30 CPD) (1).

Several lines of evidence indicate that AAs are more highly addicted to cigarette smoking than are whites. AAs are more likely to smoke their first cigarette within 10 minutes of awakening, an indicator of the severity of the dependence.(2) They are more likely to want to quit smoking and are more likely to try to quit (attempts lasting at least 24 hours),(3) but are significantly less likely than whites to be successful abstainers at one year. The quit ratio (former smokers/ever smokers) was recently reported to be 37.3% in AAs compared to 51% for whites.(2)

Research suggests that AAs, who smoke fewer CPD but take in more nicotine per cigarette, are behaving like peak-seekers (smoking primarily for the direct nicotine-mediated positive reinforcement). In contrast, whites, who smoke more CPD with less nicotine intake per cigarette, are behaving more like trough-maintainers (seeking to maintain consistent nicotine levels through the day, presumably to avoid withdrawal symptoms and/or to desensitize receptors).

Studies in our laboratory have shown that AAs metabolize nicotine, and to a greater extent, cotinine, more slowly than do whites (7,10) with slower metabolism by both the CYP2A6 and glucuronidation pathways. We have used the 3HC/COT ratio measured in blood or urine in several studies to show that CYP2A6 activity is lower in AAs compared to whites, including among children. More than 90 CYP2A6 gene variants have been identified. Although many are uncommon and their activity has not been determined (12), some are associated with large individual differences in the rate of nicotine metabolism (13). Studies of CYP2A6 genetics in AAs have only recently been reported. It is unclear whether reported gene variants in AAs can explain the substantial differences in nicotine and especially cotinine metabolism that we have observed in our prior studies. A comprehensive study of nicotine and cotinine kinetics and metabolism after IV dosing in relation to genotype, such as we have recently conducted in whites, is proposed to understand the metabolism of nicotine in AAs.

Being tested
Deuterated nicotine and cotinine
Keywords
Cigarette Smoking in African Americans
Medical subject headings
Cigarette Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Deuterated nicotine and cotinineDrug

    used as a marker for pharmacokinetic studies

Study groups in NCT00879918
Study groupRoleWhat they receive
Nicotine pharmacokineticsExperimentalcircadian smoking protocol and IV pharmacokinetic protocol
Receives: Drug: Deuterated nicotine and cotinine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Nicotine clearance

    Measured: 10 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2009 (estimated)
  2. Study startDec 2008
  3. Primary completionMar 2012
  4. Study completionMar 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00879918
Sponsor's protocol ID
10-00208
Other IDs
NIDA DA002277
Acronym
5075-AAPK1
Status last verified
May 2013
First submitted
9 Apr 2009
Last updated
24 May 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Deuterated nicotine and cotinine in people with Cigarette Smoking, run by University of California, San Francisco at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Nicotine clearance (time frame: 10 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2013.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in