Varenicline and Nicotine Interactions in Humans (VA)

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00606892
First received: January 23, 2008
Last updated: September 9, 2014
Last verified: September 2014
Results First Received: March 14, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Smoking Cessation
Interventions: Drug: Varenicline
Drug: Placebo
Drug: IV Nic

  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
Subjects were recruited from the New Haven Connecticut area through newspaper advertisements and fliers from the summer of 2007 thru the winter of 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There was no special pre-assignment procedures for this study. Thirty seven smokers signed a consent form with only 17 randomized. 13 smokers never return to clinic after signing a consent form. 2 smokers were excluded secondary to poor IV access. 5 smokers had dropped out due to a scheduling conflict.

Reporting Groups
  Description
Placebo First, Then Varenicline Subject received a placebo tablet once per day for 4 days and then received a laboratory session where they were given ascending dose of Nicotine (0.1,0.4, and 0.7mg per70kg). After a minimum washout period of 5 days,then subjects received Varenicline (1mg) per day for 4 days and then received a laboratory session where they were given ascending doses of Nicotine (0.1, 0.4, and 0.7mg per 70kg).
Varenicline First, Then Placebo Subjects received Varenicline (1mg) per day for 4 days and then received a laboratory session where they were given ascending doses of Nicotine (0.1, 0.4, and 0.7mg per 70kg).After a minimum of washout period of 5 days, then subjects received a placebo tablet once per day for 4 days and then received a laboratory session where they were given ascending dose of Nicotine (0.1,0.4, and 0.7mg per70kg).

Participant Flow for 4 periods

Period 1:   Adaptation
    Placebo First, Then Varenicline     Varenicline First, Then Placebo  
STARTED     9     8  
COMPLETED     9     8  
NOT COMPLETED     0     0  

Period 2:   First Intervention
    Placebo First, Then Varenicline     Varenicline First, Then Placebo  
STARTED     9     8  
COMPLETED     8     4  
NOT COMPLETED     1     4  
Protocol Violation                 1                 4  

Period 3:   Washout Period
    Placebo First, Then Varenicline     Varenicline First, Then Placebo  
STARTED     8     4  
COMPLETED     8     4  
NOT COMPLETED     0     0  

Period 4:   Second Intervention
    Placebo First, Then Varenicline     Varenicline First, Then Placebo  
STARTED     8     4  
COMPLETED     8     4  
NOT COMPLETED     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.
37 subjects signed consent. 17 subjects received the first treatment. Five subjects dropped out due to non-compliance with study procedures prior to study completion, and therefore were not included in the analysis. The 12 subjects who completed both interventions were included in the analysis.

Reporting Groups
  Description
Entire Study Population Includes all subjects who completed the study. (The total number of subjects who were enrolled in both arms of the study.)

Baseline Measures
    Entire Study Population  
Number of Participants  
[units: participants]
  12  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     12  
>=65 years     0  
Age  
[units: years]
Mean (Standard Deviation)
  34.0  (9.3)  
Gender  
[units: participant]
 
Female     7  
Male     5  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Subjective Responses to Intravenous Nicotine   [ Time Frame: 30 minutes after each nicotine infusion ]

2.  Secondary:   Mean Reaction Time (RT) on Modified Stroop Task.   [ Time Frame: pre-nicotine, and 30 min after last nicotine infusion (Post-Nicotine) ]

3.  Secondary:   Cotinine Levels   [ Time Frame: Before each laboratory session on day 5 ]

4.  Secondary:   Heart Rate   [ Time Frame: 30 minutes after each nicotine infusion ]

5.  Secondary:   Changes in Systolic and Diastolic Blood Pressure   [ Time Frame: 30 minutes after each nicotine infusion ]


  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: Mehmet Sofuoglu, M.D., Ph.D.
Organization: Yale University
phone: 203-937-4809
e-mail: mehmet.sofuoglu@yale.edu


Publications of Results:

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00606892     History of Changes
Other Study ID Numbers: HIC # 0702002338, MIRECC 000000000, DPMC, R01DA014537
Study First Received: January 23, 2008
Results First Received: March 14, 2012
Last Updated: September 9, 2014
Health Authority: United States: Federal Government