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insufficient recuirment
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| Name | Class |
|---|---|
| Brown University | OTHER |
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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| varenicline | Drug | varenicline 0.5mg daily for days 1-3, 0.5mg twice daily for days 3-7, then 1mg twice daily for length of hospitalization |
|
| Measure | Description | Time Frame |
|---|---|---|
| improvement in Quick Inventory of Depressive Symptoms (QIDS-SR) | duration of hospitalization | |
| improvement in Minnesota Nicotine Withdrawal Scale | days (duration of hospitalization) |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
(3) Current pregnancy or breastfeeding.
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| Name | Affiliation | Role |
|---|---|---|
| Noah S Philip, MD | Butler Hospital | Principal Investigator |
| Lawrence H Price, MD | Butler Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Butler Hospital | Providence | Rhode Island | 02906 | United States |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| D003866 | Depressive Disorder |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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| ID | Term |
|---|---|
| D000068580 | Varenicline |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| D011810 | Quinoxalines |