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Mood and Anti-craving Effects of Varenicline in Psychiatric Inpatients

Primary Purpose

Smoking, Depressive Disorder

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

varenicline

About this trial

This is an interventional treatment trial for Smoking focused on measuring craving, smoking, depression

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Butler Hospital

Outcomes

Primary Outcome Measures

improvement in Quick Inventory of Depressive Symptoms (QIDS-SR)

improvement in Minnesota Nicotine Withdrawal Scale

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00525928

First Posted

September 4, 2007

Last Updated

July 20, 2015

Sponsor

Butler Hospital

Collaborators

Brown University

1. Study Identification

Unique Protocol Identification Number

NCT00525928

Brief Title

Mood and Anti-craving Effects of Varenicline in Psychiatric Inpatients

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Withdrawn

Why Stopped

insufficient recuirment

Study Start Date

October 2007 (undefined)

Primary Completion Date

October 2008 (Actual)

Study Completion Date

October 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Butler Hospital

Collaborators

Brown University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Smoking, Depressive Disorder

Keywords

craving, smoking, depression

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

varenicline

Other Intervention Name(s)

Chantix

Intervention Description

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

Primary Outcome Measure Information:

Title

improvement in Quick Inventory of Depressive Symptoms (QIDS-SR)

Time Frame

duration of hospitalization

Title

improvement in Minnesota Nicotine Withdrawal Scale

Time Frame

days (duration of hospitalization)

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Noah S Philip, MD

Organizational Affiliation

Butler Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Lawrence H Price, MD

Organizational Affiliation

Butler Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Butler Hospital

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02906

Country

United States

12. IPD Sharing Statement

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Mood and Anti-craving Effects of Varenicline in Psychiatric Inpatients

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