Varenicline and Alcohol in Inpatient Addictions Program (IAP)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Mark Frye, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01169610
First received: July 22, 2010
Last updated: July 19, 2013
Last verified: July 2013
Results First Received: July 19, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Alcoholism
Nicotine Dependence
Intervention: Drug: Varenicline

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment period 1/2011 - 9/2012

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
Open Label Varenicline : Varenicline is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4 to 7, and then to the maintenance dose of 1 mg twice daily for the remaining 23 weeks of treatment. All subjects will receive open-label varenicline in blister packs.

Participant Flow:   Overall Study
    Open Label  
STARTED     1  
COMPLETED     1  
NOT COMPLETED     0  



  Baseline Characteristics
  Hide 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
Open Label Varenicline : Varenicline is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4 to 7, and then to the maintenance dose of 1 mg twice daily for the remaining 23 weeks of treatment. All subjects will receive open-label varenicline in blister packs.

Baseline Measures
    Open Label  
Number of Participants  
[units: participants]
  1  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     1  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  35  
Gender  
[units: participants]
 
Female     0  
Male     1  
Region of Enrollment  
[units: participants]
 
United States     1  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Continuous Alcohol Abstinence   [ Time Frame: Two years ]

2.  Primary:   Heavy Drinking Days   [ Time Frame: Two years ]

3.  Secondary:   7-day Point Prevalence Smoking Abstinence   [ Time Frame: Two years ]

4.  Secondary:   Prolonged Smoking Abstinence   [ Time Frame: Two years ]

5.  Secondary:   Tolerability   [ Time Frame: Two years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Mark A. Frye, MD
Organization: Mayo Clinic
phone: 507-255-9391
e-mail: mfrye@mayo.edu


No publications provided


Responsible Party: Mark Frye, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01169610     History of Changes
Other Study ID Numbers: 10-002699
Study First Received: July 22, 2010
Results First Received: July 19, 2013
Last Updated: July 19, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board