Mood and Anti-craving Effects of Varenicline in Psychiatric Inpatients

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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00525928

Enrollment

Registered

2007-09-06

Start date

2007-10-31

Completion date

2008-10-31

Last updated

2015-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressive Disorder, Smoking

Keywords

craving, smoking, depression

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.

Interventions

DRUGvarenicline

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026