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Do Treatments for Smoking Cessation Affect Alcohol Drinking?

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ClinicalTrials.gov Identifier: NCT00580645
Recruitment Status : Completed
First Posted : December 27, 2007
Results First Posted : February 7, 2018
Last Update Posted : February 7, 2018
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Sherry McKee, Yale University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Alcohol Drinking
Interventions: Drug: varenicline
Drug: placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
Placebo

Placebo controlled

placebo: placebo

1 mg/Day Varenicline 1mg/day with 1-week medication lead-in period. The starting dose is 0.5 mg/day for days 1-5, followed by 0.5mg twice daily for days 6-7. 0.5mg twice daily administered during laboratory session (day 8) and for 4 weeks after laboratory session.
2 mg/Day Varenicline 2mg/day with 1-week medication lead-in period. The starting dose is 0.5 mg/day for Day 1 and 2, 0.5 mg twice daily for Days 3-5, and 1.0mg twice daily on Days 6-7. 1.0mg twice daily administered during laboratory session (day 8) and for 4 weeks after laboratory session.

Participant Flow:   Overall Study
    Placebo   1 mg/Day Varenicline   2 mg/Day Varenicline
STARTED   20   20   20 
COMPLETED   20   20   20 
NOT COMPLETED   0   0   0 



  Baseline Characteristics

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
Placebo

Placebo controlled

placebo: placebo

1 mg/Day Varenicline 1mg/day with 1-week medication lead-in period. The starting dose is 0.5 mg/day for days 1-5, followed by 0.5mg twice daily for days 6-7. 0.5mg twice daily administered during laboratory session (day 8) and for 4 weeks after laboratory session.
2 mg/Day Varenicline 2mg/day with 1-week medication lead-in period. The starting dose is 0.5 mg/day for Day 1 and 2, 0.5 mg twice daily for Days 3-5, and 1.0mg twice daily on Days 6-7. 1.0mg twice daily administered during laboratory session (day 8) and for 4 weeks after laboratory session.
Total Total of all reporting groups

Baseline Measures
   Placebo   1 mg/Day Varenicline   2 mg/Day Varenicline   Total 
Overall Participants Analyzed 
[Units: Participants]
 20   20   20   60 
Age 
[Units: Years]
Mean (Standard Deviation)
 34.2  (9.52)   33.35  (8.51)   34.15  (11.6)   33.90  (9.80) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      6  30.0%      8  40.0%      5  25.0%      19  31.7% 
Male      14  70.0%      12  60.0%      15  75.0%      41  68.3% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
       
Hispanic   0   1   1   2 
African American   8   7   2   17 
White   11   10   15   36 
Other   1   2   2   5 


  Outcome Measures

1.  Primary:   Number of Drinks Consumed   [ Time Frame: 2 hour ad-lib drinking period, during the laboratory session (Day 8) ]

2.  Secondary:   Alcohol Craving   [ Time Frame: during laboratory session (Day 8) at baseline ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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 School of Medicine
phone: 203-737-3529
e-mail: sherry.mckee@yale.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Sherry McKee, Yale University
ClinicalTrials.gov Identifier: NCT00580645     History of Changes
Other Study ID Numbers: HIC0702002391
R01AA015596-01 ( U.S. NIH Grant/Contract )
First Submitted: December 25, 2007
First Posted: December 27, 2007
Results First Submitted: November 20, 2017
Results First Posted: February 7, 2018
Last Update Posted: February 7, 2018