Mood and Anti-craving Effects of Varenicline in Psychiatric Inpatients

This study has been withdrawn prior to enrollment.
(insufficient recuirment)
Sponsor:
Collaborator:
Brown University
Information provided by:
Butler Hospital
ClinicalTrials.gov Identifier:
NCT00525928
First received: September 4, 2007
Last updated: September 27, 2010
Last verified: September 2010

September 4, 2007
September 27, 2010
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 ClinicalTrials.gov 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
Not Provided
Not Provided
 
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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
100
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.

Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00525928
0707-003
Not Provided
Not Provided
Butler Hospital
Brown University
Principal Investigator: Noah S Philip, MD Butler Hospital
Study Director: Lawrence H Price, MD Butler Hospital
Butler Hospital
September 2010

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