Sensitivity to Intravenous Nicotine: Genetic Moderators
Completed · Phase 1
Conditions studied: Nicotine Dependence
In brief
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.
Key facts
- Study ID
- NCT00969137
- Run by
- Yale University
- People needed
- 213
- Starts
- 2009-06-02
- Expected to finish
- 2016-06-01
- Last updated by the study team
- 2017-04-19
Who can join
Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Female and male smokers, aged 18 to 50 years;
- History of smoking daily for the past 12 months, 10-25 cigarettes daily;
- Not seeking treatment at the time of the study for nicotine dependence;
- Have a FTND score of at least 5 and CO level > 10ppm;
- In good health as verified by medical history, screening examination, and screening laboratory tests;
- For women, not pregnant as determined by pregnancy screening, nor breast feeding, and using acceptable birth control methods.
You may not qualify if…
- History of major medical illnesses that the physician investigator deems as contraindicated for the patient to be in the study;
- Regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics) and recent psychiatric diagnosis and treatment for Axis I disorders including major depression, bipolar affective disorder, schizophrenia or panic disorder;
- Abuse of alcohol or any other recreational or prescription drugs.
Where it is running
- Department of Veterans Affairs — West Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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