Status:
COMPLETED
Effects of Varenicline on Cigarette Self Administration
Lead Sponsor:
New York State Psychiatric Institute
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Nicotine Dependence
Eligibility:
All Genders
21-45 years
Phase:
PHASE2
Brief Summary
The investigators hypothesize that varenicline will dose dependently attenuate the subjective effects of cigarettes after a period of abstinence. Also, treatment with varenicline will dose dependently...
Detailed Description
Tobacco use is the leading preventable cause of death in the U.S.A. Every year 400,000 people die from cigarette smoking and in 2006, one out of every five deaths in the US were smoking related. Recen...
Eligibility Criteria
Inclusion
- A diagnosis of nicotine dependence with physiological dependence, smoking at least 15 cigarettes/day during the last 3 months.
- Not interested in treatment
- Medically healthy on the basis of physical examination and medical history, vital signs, EKG and laboratory tests, with a negative pregnancy test for females.
- Able to perform study procedures
- Males or females between the ages of 21-45 yrs
- Female participants agree to use an effective method of birth control during the course of the study
Exclusion
- A diagnosis of abuse or dependence on alcohol or drugs other than nicotine
- Current Axis I diagnosis or current treatment with psychotropic medications (within last 3 months)
- Lifetime history of schizophrenia or other psychotic disorders, bipolar disorder, or anxiety disorders
- Currently seeking treatment for nicotine dependence
- Participants on parole or probation
- History of significant recent violent behavior
- Blood pressure \> 150/90
- History of allergic reaction to any of the study medications
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00731055
Start Date
February 1 2008
End Date
May 1 2009
Last Update
June 18 2018
Active Locations (1)
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1
New York State Psychiatric Institute
New York, New York, United States, 10032