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Completed

NCT Number: NCT00580853

The Effect of Varenicline (Chantix) and Bupropion (Zyban) on Smoking Lapse Behavior

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.

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Key information

Conditions

Smoking Lapse Behavior Behavior Health Behavior Smoking Cessation

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Yale Center for Clinical Investigation, Yale University

New Haven, Connecticut, 06519, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 Diagnostic and Statistical Manual 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

Treatment and study plan

Varenicline

Drug

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).

Other names: Chantix

bupropion

Drug

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).

Other names: Zyban

Placebo

Drug

Placebo

Primary outcomes

  1. Latency to Initiate Ad-lib Smoking Session

    Time frame: 0 to 50 minutes

    minutes to start smoking (range 0 to 50 minutes)

Secondary outcomes

  1. Number of Cigarettes Smoked During the 60 Minute Ad-lib Period

    Time frame: 60 minutes

    number of cigarettes smoked (range 0-8) during the 60 minute ad-lib period

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Important dates

Study start
2007
Primary completion
2016
Study completion
2016
First posted
Dec 27, 2007
Registry last updated
Feb 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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