Status:
COMPLETED
Sensitivity to Intravenous Nicotine: Genetic Moderators
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Nicotine Dependence
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief 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 nic...
Detailed Description
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 nico...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 2 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
213 Patients enrolled
Trial Details
Trial ID
NCT00969137
Start Date
June 2 2009
End Date
June 1 2016
Last Update
April 19 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Veterans Affairs
West Haven, Connecticut, United States, 06516