Mood and Anti-craving Effects of Varenicline in Psychiatric Inpatients
Primary Purpose
Smoking, Depressive Disorder
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
varenicline
Sponsored by
About this trial
This is an interventional treatment trial for Smoking focused on measuring craving, smoking, depression
Eligibility Criteria
Inclusion Criteria:
- Admission to Butler Hospital during study period.
- Current tobacco users ages 18-65.
- Able to give written, informed consent.
Exclusion Criteria:
- Past adverse reaction to varenicline.
- Treatment with varenicline on admission to Butler Hospital.
- Renal failure or dialysis
(3) Current pregnancy or breastfeeding.
Sites / Locations
- Butler Hospital
Outcomes
Primary Outcome Measures
improvement in Quick Inventory of Depressive Symptoms (QIDS-SR)
improvement in Minnesota Nicotine Withdrawal Scale
Secondary Outcome Measures
no significant intolerability, measured by the Frequency, Intensity, and Burden of Side Effects (FIBSER) and Adverse Events Checklist (SAFTEE-SI)
Full Information
NCT ID
NCT00525928
First Posted
September 4, 2007
Last Updated
July 20, 2015
Sponsor
Butler Hospital
Collaborators
Brown University
1. Study Identification
Unique Protocol Identification Number
NCT00525928
Brief Title
Mood and Anti-craving Effects of Varenicline in Psychiatric Inpatients
Official Title
Assessment of Response to Open-label Treatment With Varenicline in Psychiatric Inpatients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Withdrawn
Why Stopped
insufficient recuirment
Study Start Date
October 2007 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Butler Hospital
Collaborators
Brown University
4. Oversight
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking, Depressive Disorder
Keywords
craving, smoking, depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
varenicline
Other Intervention Name(s)
Chantix
Intervention Description
varenicline 0.5mg daily for days 1-3, 0.5mg twice daily for days 3-7, then 1mg twice daily for length of hospitalization
Primary Outcome Measure Information:
Title
improvement in Quick Inventory of Depressive Symptoms (QIDS-SR)
Time Frame
duration of hospitalization
Title
improvement in Minnesota Nicotine Withdrawal Scale
Time Frame
days (duration of hospitalization)
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Admission to Butler Hospital during study period.
Current tobacco users ages 18-65.
Able to give written, informed consent.
Exclusion Criteria:
Past adverse reaction to varenicline.
Treatment with varenicline on admission to Butler Hospital.
Renal failure or dialysis
(3) Current pregnancy or breastfeeding.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noah S Philip, MD
Organizational Affiliation
Butler Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lawrence H Price, MD
Organizational Affiliation
Butler Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Butler Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Mood and Anti-craving Effects of Varenicline in Psychiatric Inpatients
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