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

This study has been completed.
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Sherry McKee, Yale University
ClinicalTrials.gov Identifier:
NCT00580853
First received: December 25, 2007
Last updated: January 20, 2017
Last verified: January 2017
Results First Received: October 21, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Investigator, Outcomes Assessor;   Primary Purpose: Treatment
Condition: Smoking Lapse Behavior
Interventions: Drug: varenicline
Drug: bupropion
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Varenicline

varenicline 2mg/day

varenicline: 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).

Bupropion

Bupropion 300mg/day

bupropion: 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

Placebo Control

Placebo: Placebo


Participant Flow:   Overall Study
    Varenicline   Bupropion   Placebo
STARTED   20   21   21 
COMPLETED   20   21   21 
NOT COMPLETED   0   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Varenicline

varenicline 2mg/day

varenicline: 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).

Bupropion

Bupropion 300mg/day

bupropion: 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

Placebo Control

Placebo: Placebo

Total Total of all reporting groups

Baseline Measures
   Varenicline   Bupropion   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 20   21   21   62 
Age 
[Units: Years]
Mean (Standard Deviation)
 34.95  (11.36)   34.95  (9.70)   36.47  (10.95)   35.47  (6.95) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      9  45.0%      8  38.1%      9  42.9%      26  41.9% 
Male      11  55.0%      13  61.9%      12  57.1%      36  58.1% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Latency to Initiate Ad-lib Smoking Session   [ Time Frame: 0 to 50 minutes ]

2.  Secondary:   Number of Cigarettes Smoked During the 60 Minute Ad-lib Period   [ Time Frame: 60 minutes ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Sherry McKee PhD
Organization: Yale University
phone: 203-737-3529
e-mail: sherry.mckee@yale.edu



Responsible Party: Sherry McKee, Yale University
ClinicalTrials.gov Identifier: NCT00580853     History of Changes
Other Study ID Numbers: HIC0702002390
P50AA015632 ( US NIH Grant/Contract Award Number )
Study First Received: December 25, 2007
Results First Received: October 21, 2016
Last Updated: January 20, 2017