- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00525928
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.
Study Overview
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.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02906
- Butler Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
improvement in Quick Inventory of Depressive Symptoms (QIDS-SR)
Time Frame: duration of hospitalization
|
duration of hospitalization
|
improvement in Minnesota Nicotine Withdrawal Scale
Time Frame: days (duration of hospitalization)
|
days (duration of hospitalization)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
duration of hospitalization
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Noah S Philip, MD, Butler Hospital
- Study Director: Lawrence H Price, MD, Butler Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0707-003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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