Phase 2 N=16 Randomized Double-blind Treatment

Effects of Varenicline on Cigarette Self Administration

Nicotine Dependence

Bottom Line

View on ClinicalTrials.gov: NCT00731055 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2015

Primary outcome: Primary: Cigarette Choice — 3.67; 3.17; 2.83; 2.83 number of cigarette choices (0-9)

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Varenicline (Drug); Placebo (Drug)
Age: Adult · 21+ yrs
Sex: All
Sponsor: New York State Psychiatric Institute
Primary completion: May 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Cigarette Choice	3.67; 3.17; 2.83; 2.83	—

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.

Eligibility Criteria

Inclusion Criteria

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 Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00731055). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.