Sensitivity to Intravenous Nicotine: Genetic Moderators

• Status: Completed
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Yale University
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Nicotine

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.