Mood and Anti-craving Effects of Varenicline in Psychiatric Inpatients

Not Applicable

Withdrawn

• Conditions: Smoking; Depressive Disorder

• Registration Number: NCT00525928
• Lead Sponsor: Butler Hospital

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.

Study Timeline

• Study First Submitted: 2007-09-04
• Study First Submitted QC: 2007-09-04
• Study First Posted: 2007-09-06
• Study Start: 2007-10
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-20
• Last Update Posted: 2015-07-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
improvement in Quick Inventory of Depressive Symptoms (QIDS-SR)	duration of hospitalization
improvement in Minnesota Nicotine Withdrawal Scale	days (duration of hospitalization)

Secondary Outcome Measures

Name	Time	Method
no significant intolerability, measured by the Frequency, Intensity, and Burden of Side Effects (FIBSER) and Adverse Events Checklist (SAFTEE-SI)	duration of hospitalization

Trial Locations

Locations (1)

Butler Hospital; 🇺🇸 Providence, Rhode Island, United States