Mood and Anti-craving Effects of Varenicline in Psychiatric Inpatients

This study has been withdrawn prior to enrollment.
(insufficient recuirment)
Sponsor:
Collaborator:
Brown University
Information provided by:
Butler Hospital
ClinicalTrials.gov Identifier:
NCT00525928
First received: September 4, 2007
Last updated: September 27, 2010
Last verified: September 2010
  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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Assessment of Response to Open-label Treatment With Varenicline in Psychiatric Inpatients

Resource links provided by NLM:


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
Estimated Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    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
    Other Name: Chantix
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:

  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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

ClinicalTrials.gov Identifier: NCT00525928     History of Changes
Other Study ID Numbers: 0707-003
Study First Received: September 4, 2007
Last Updated: September 27, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Butler Hospital:
craving
smoking
depression

Additional relevant MeSH terms:
Depressive Disorder
Depression
Mood Disorders
Mental Disorders
Behavioral Symptoms
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 16, 2014