Mood and Anti-craving Effects of Varenicline in Psychiatric Inpatients
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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 |
- 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) ]
- 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) |
-
Drug: varenicline
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 |
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.
Contacts and Locations| United States, Rhode Island | |
| Butler Hospital | |
| Providence, Rhode Island, United States, 02906 | |
| 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 Smoking Mood Disorders Mental Disorders Behavioral Symptoms Habits 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 May 16, 2013