Overview

This trial is active, not recruiting.

Condition smoking lapse behavior
Treatments varenicline, bupropion, placebo
Phase phase 2
Sponsor Yale University
Collaborator National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Start date April 2007
End date July 2016
Trial size 60 participants
Trial identifier NCT00580853, HIC0702002390, P50AA015632

Summary

The purpose of this study is to examine how smoking cessation medications (varenicline, bupropion) affect the ability to resist smoking and also subsequent ad-lib smoking in non-treatment seeking daily smokers.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model factorial assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
varenicline 2mg/day
varenicline Chantix
2mg/day, with 1-week lead-in medication period The starting dose is 0.5 mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5 and then 1mg twice daily for days 4-7. 1mg administered during laboratory session (day 8).
(Experimental)
Bupropion 300mg/day
bupropion Zyban
300mg/day, with 1-week lead-in medication period The starting dose is 150mg/day for days 1-3, 300mg/day for days 4-7. 300mg administered during laboratory session (day 8).
(Placebo Comparator)
Placebo Control
placebo
Placebo

Primary Outcomes

Measure
latency to initiate ad-lib smoking session
time frame: in the laboratory session

Secondary Outcomes

Measure
number of cigarettes smoked during the ad-lib period
time frame: during the laboratory session

Eligibility Criteria

Male or female participants from 21 years up to 55 years old.

Inclusion Criteria: - ages 18-55 - able to read and write in English - Smokers Exclusion Criteria: - any significant current medical or psychiatric conditions that would contraindicate smoking - current DSM-IV abuse or dependence of other substances, other than nicotine dependence or alcohol abuse - positive test result at intake appointments on urine drug screens conducted for opiates, cocaine, or benzodiazepines - women who are pregnant or nursing - suicidal, homicidal, or evidence of current severe mental illness - participants prescribed any psychotropic drug in the 30 days prior to study enrollment - blood donation within the past 6 weeks - individuals seeking treatment for smoking cessation or have attempted to quit smoking within the past 3 months - specific exclusions for bupropion administration not already specified, including: have taken monoamine inhibitors in the past 6 weeks; history of anorexia or bulimia; previous hypersensitivity to bupropion; history of alcohol or drug dependence in the past year; history of seizure disorder of any etiology - known allergy to varenicline or taking H2blockers - participation within the past 8 weeks in other studies that involve additive blood sampling and/or interventional measures that would be considered excessive in combination with the current study

Additional Information

Official title The Effect of Varenicline (Chantix) and Bupropion (Zyban) on Smoking Lapse Behavior
Principal investigator Sherry A McKee, PhD
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Yale University.