Mood and Anti-craving Effects of Varenicline in Psychiatric Inpatients
This study of psychiatric inpatients will assess mood effects of varenicline, as well as assess if varenicline decreased nicotine cravings acutely.
This study will also measure side effects of varenicline when given in addition to other psychiatric and non-psychiatric medications.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Assessment of Response to Open-label Treatment With Varenicline in Psychiatric Inpatients|
- improvement in Quick Inventory of Depressive Symptoms (QIDS-SR) [ Time Frame: duration of hospitalization ]
- improvement in Minnesota Nicotine Withdrawal Scale [ Time Frame: days (duration of hospitalization) ]
- no significant intolerability, measured by the Frequency, Intensity, and Burden of Side Effects (FIBSER) and Adverse Events Checklist (SAFTEE-SI) [ Time Frame: duration of hospitalization ]
|Study Start Date:||October 2007|
|Estimated Study Completion Date:||October 2008|
|Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
This study will measure mood effects and rapid anti-craving effects of varenicline in psychiatric inpatients. Patients will be offered to participate in the trial if they wish to stop smoking or wish to decrease nicotine cravings while in the hospital. They will not be able to use nicotine replacement products when taking varenicline.
Patients will be assessed with the QIDS-SR16, Minnesota Nicotine Withdrawal Scale as well as the Frequency, Intensity, and Burden of Side Effects (FISER) at baseline and daily during the trial; patients will be asked to enroll for the duration of their hospitalization. Patients will be assessed as to whether they wish to continue varenicline post-discharge.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00525928
|United States, Rhode Island|
|Providence, Rhode Island, United States, 02906|
|Principal Investigator:||Noah S Philip, MD||Butler Hospital|
|Study Director:||Lawrence H Price, MD||Butler Hospital|