Mood and Anti-craving Effects of Varenicline in Psychiatric Inpatients

Smoking Clinical Trial

Official title:

Assessment of Response to Open-label Treatment With Varenicline in Psychiatric Inpatients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00525928
• Other study ID #: 0707-003
• Status: Withdrawn
• Phase: N/A
• First received: September 4, 2007
• Last updated: July 20, 2015
• Start date: October 2007
• Est. completion date: October 2008

Study information

• Verified date: July 2015
• Source: Butler Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Smoking

Intervention

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

Locations

Country	Name	City	State
United States	Butler Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Butler Hospital	Brown University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	improvement in Quick Inventory of Depressive Symptoms (QIDS-SR)		duration of hospitalization
Primary	improvement in Minnesota Nicotine Withdrawal Scale		days (duration of hospitalization)
Secondary	no significant intolerability, measured by the Frequency, Intensity, and Burden of Side Effects (FIBSER) and Adverse Events Checklist (SAFTEE-SI)		duration of hospitalization