Mood and Anti-craving Effects of Varenicline in Psychiatric Inpatients

July 20, 2015 updated by: Butler Hospital

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

Status

Withdrawn

Conditions

Intervention / Treatment

Drug: varenicline

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

Interventional

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Sponsor

Butler Hospital

Collaborators

Brown University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

October 1, 2008

Study Completion (Anticipated)