Mechanisms of the Nicotine Metabolism Effect on Tobacco Dependence
NMR
1 other identifier
interventional
305
1 country
1
Brief Summary
The purpose of the study is to learn more about tobacco dependence and nicotine metabolism in African-Americans and whites, by studying to see if how fast a person metabolizes nicotine (how the body breaks down nicotine into inactive compounds) affects how dependent they are on smoking cigarettes. The investigators believe that people with a faster rate of metabolism may have more severe nicotine withdrawal symptoms and also may have a harder time trying to quit smoking.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 14, 2012
CompletedFirst Posted
Study publicly available on registry
June 25, 2012
CompletedStudy Start
First participant enrolled
July 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedDecember 3, 2015
December 1, 2015
3.1 years
June 14, 2012
December 1, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Nicotine withdrawal symptoms
Total withdrawal score as measured by Minnesota Nicotine Withdrawal Scale
6 hours post nicotine load
Secondary Outcomes (4)
Cognitive performance
6 hours post nicotine load
Smoking behavior: number of cigarettes
90 minutes post-abstinence
Smoking behavior: number of puffs per cigarette
90 minutes post-abstinence
Smoking behavior: time to first post-reward cigarette
90 minutes post-abstinence
Study Arms (1)
Smoking abstinence
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- African-American or Caucasian
- Age 18-70 years
- Regular smoker of 5 or more cigarettes per day
- Saliva cotinine of 100 ng/ml or greater
You may not qualify if:
- Obese (BMI \> 38) or underweight (BMI \< 17)
- Major systemic or psychiatric condition
- Medications that are inducers of CYP2A6
- History of alcohol abuse
- Positive drug urine tox test
- Pregnancy or breast feeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
San Francisco General Hospital
San Francisco, California, 94110, United States
Related Publications (2)
Nardone N, Shahid M, Strasser AA, Dempsey DA, Benowitz NL. The influence of nicotine metabolic rate on working memory over 6 hours of abstinence from nicotine. Pharmacol Biochem Behav. 2020 Jan;188:172836. doi: 10.1016/j.pbb.2019.172836. Epub 2019 Dec 5.
PMID: 31812759DERIVEDLiakoni E, Edwards KC, St Helen G, Nardone N, Dempsey DA, Tyndale RF, Benowitz NL. Effects of Nicotine Metabolic Rate on Withdrawal Symptoms and Response to Cigarette Smoking After Abstinence. Clin Pharmacol Ther. 2019 Mar;105(3):641-651. doi: 10.1002/cpt.1238. Epub 2018 Oct 25.
PMID: 30242831DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Neal L Benowitz, MD
University of California, San Francisco
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 14, 2012
First Posted
June 25, 2012
Study Start
July 1, 2012
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
December 3, 2015
Record last verified: 2015-12