Sensitivity to Intravenous Nicotine: Genetic Moderators
To determine if the mu opioid receptor gene (OPRM1) A118G polymorphism moderates the subjective-rewarding effects of intravenous (IV) nicotine in male and female smokers. The subjective effects of nicotine will be measured with a Drug Effects Questionnaire, including the ratings of "good effects" and "drug liking". We hypothesize that smokers with the AG/GG genotype for the OPRM1 A118G will have attenuated subjective-rewarding effects from IV nicotine when compared to those with AA genotype.
Influence of OPRM1 A118G Status on Subjective Responses to IV Nicotine.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
|Official Title:||Sensitivity to Intravenous Nicotine: Genetic Moderators|
- primary hypotheses will test the influence of OPRM1 A118G status on subjective responses to IV nicotine, which will be measured with the drug effects questionnaire (DEQ). [ Time Frame: Injections 30 minutes apart ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2009|
|Estimated Study Completion Date:||August 2014|
|Estimated Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
Maximum doses of nicotine 2mg
Other Name: Nicotine
Increasing evidence suggest that MOR contribute to nicotine's rewarding effect. Further, the functional OPRM1 A118G variant has been linked to rewarding effects of alcohol in alcohol users and to nicotine in female smokers. Since no previous studies examined the influence of the A118G variation on pure nicotine responses, the next logical step is to evaluate how this genetic polymorphism affects nicotine's rewarding, cognitive, and physiological effects using IV nicotine administration in male and female smokers. In addition, the association of the G398A polymorphism of the CHRNA5 gene (rs16969968) with maximal response to nicotinic agonists justifies examination of this SNP as a moderator of IV nicotine sensitivity in humans (Bierut et al. 2008). This SNP will be examined in an exploratory fashion since it is not feasible to fully stratify the study sample for multiple SNPs. The frequency of rs16969968 SNP ranges from 35%-42% among those of European ancestry, making it feasible to examine this variation in our subject sample.
Currently this study is active and enrollment is continuing. Currently there are 186 completers and on going.(Dec 2013)
|Contact: Lance Barnesfirstname.lastname@example.org|
|Contact: Stacy Minnix, BSWemail@example.com|
|United States, Connecticut|
|Department of Veterans Affairs||Recruiting|
|West Haven, Connecticut, United States, 06516|
|Contact: Mehmet Sofuoglu, M.D., Ph.D. 203-937-4809 firstname.lastname@example.org|
|Contact: Joel Gelernter, M.D. 932-5711 ext 3590 email@example.com|
|Principal Investigator: Mehmet Sofuoglu, M.D., Ph.D.|
|Principal Investigator:||Mehmet Sofuoglu, M.D,Ph.D.||Yale University|