Mood and Anti-Craving Effects of Varenicline in Psychiatric Inpatients - Full Text View

Sponsors and Collaborators:	Butler Hospital Brown University
Information provided by:	Butler Hospital
ClinicalTrials.gov Identifier:	NCT00525928

Purpose

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.

Condition	Intervention
Smoking Depressive Disorder	Drug: varenicline

MedlinePlus related topics: Depression Smoking

Drug Information available for: Varenicline

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Assessment of Response to Open-Label Treatment With Varenicline in Psychiatric Inpatients

Further study details as provided by Butler Hospital:

Primary Outcome Measures:

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) ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	100
Study Start Date:	October 2007
Study Completion Date:	May 2008
Estimated Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Intervention Details:

varenicline 0.5mg daily for days 1-3, 0.5mg twice daily for days 3-7, then 1mg twice daily for length of hospitalization

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00525928

Locations

United States, Rhode Island
Butler Hospital
Providence, Rhode Island, United States, 02906

Sponsors and Collaborators

Butler Hospital

Brown University

Investigators

Principal Investigator:	Noah S Philip, MD	Butler Hospital
Study Director:	Lawrence H Price, MD	Butler Hospital

More Information

Study ID Numbers:	0707-003
Study First Received:	September 4, 2007
Last Updated:	May 28, 2008
ClinicalTrials.gov Identifier:	NCT00525928
Health Authority:	United States: Institutional Review Board

Keywords provided by Butler Hospital:

craving
smoking
depression

Study placed in the following topic categories:

Smoking
Depression
Mental Disorders

Mood Disorders
Depressive Disorder
Behavioral Symptoms

Additional relevant MeSH terms:

Habits

ClinicalTrials.gov processed this record on January 14, 2009