Effects of Varenicline on Cigarette Self Administration

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

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 weaken the severity of nicotine withdrawal symptoms. Thirdly, we hypothesize that treatment with varenicline will dose dependently decrease cigarette self-administration in the model proposed.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: New York State Psychiatric Institute
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Varenicline

Criteria

Inclusion Criteria:

1. A diagnosis of nicotine dependence with physiological dependence, smoking at least 15 cigarettes/day during the last 3 months.

2. Not interested in treatment

3. Medically healthy on the basis of physical examination and medical history, vital signs, EKG and laboratory tests, with a negative pregnancy test for females.

4. Able to perform study procedures

5. Males or females between the ages of 21-45 yrs

6. Female participants agree to use an effective method of birth control during the course of the study

Exclusion Criteria:

1. A diagnosis of abuse or dependence on alcohol or drugs other than nicotine

2. Current Axis I diagnosis or current treatment with psychotropic medications (within last 3 months)

3. Lifetime history of schizophrenia or other psychotic disorders, bipolar disorder, or anxiety disorders

4. Currently seeking treatment for nicotine dependence

5. Participants on parole or probation

6. History of significant recent violent behavior

7. Blood pressure > 150/90

8. History of allergic reaction to any of the study medications