Mood and Anti-craving Effects of Varenicline in Psychiatric Inpatients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00525928
Recruitment Status : Withdrawn (insufficient recuirment)
First Posted : September 6, 2007
Last Update Posted : July 21, 2015
Brown University
Information provided by:
Butler Hospital

September 4, 2007
September 6, 2007
July 21, 2015
October 2007
October 2008   (Final data collection date for primary outcome measure)
  • 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) ]
Same as current
Complete list of historical versions of study NCT00525928 on Archive Site
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 ]
Same as current
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Mood and Anti-craving Effects of Varenicline in Psychiatric Inpatients
Assessment of Response to Open-label Treatment With 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.

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.

Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Smoking
  • Depressive Disorder
Drug: varenicline
varenicline 0.5mg daily for days 1-3, 0.5mg twice daily for days 3-7, then 1mg twice daily for length of hospitalization
Other Name: Chantix
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
October 2008
October 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Admission to Butler Hospital during study period.
  2. Current tobacco users ages 18-65.
  3. Able to give written, informed consent.

Exclusion Criteria:

  1. Past adverse reaction to varenicline.
  2. Treatment with varenicline on admission to Butler Hospital.
  3. Renal failure or dialysis

(3) Current pregnancy or breastfeeding.

Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Butler Hospital
Brown University
Principal Investigator: Noah S Philip, MD Butler Hospital
Study Director: Lawrence H Price, MD Butler Hospital
Butler Hospital
July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP