NCT00525928

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2007

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 6, 2007

Completed
25 days until next milestone

Study Start

First participant enrolled

October 1, 2007

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

July 21, 2015

Status Verified

July 1, 2015

Enrollment Period

1 year

First QC Date

September 4, 2007

Last Update Submit

July 20, 2015

Conditions

SmokingDepressive Disorder

Keywords

cravingsmokingdepression

Outcome Measures

Primary Outcomes (2)

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

    duration of hospitalization

  • improvement in Minnesota Nicotine Withdrawal Scale

    days (duration of hospitalization)

Secondary Outcomes (1)

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

    duration of hospitalization

Interventions

vareniclineDRUG

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

Also known as: Chantix

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Admission to Butler Hospital during study period.
  • Current tobacco users ages 18-65.
  • Able to give written, informed consent.

You may not qualify if:

  • Past adverse reaction to varenicline.
  • Treatment with varenicline on admission to Butler Hospital.
  • Renal failure or dialysis
  • (3) Current pregnancy or breastfeeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

SmokingDepressive DisorderDepression

Interventions

Varenicline

Condition Hierarchy (Ancestors)

BehaviorMood DisordersMental DisordersBehavioral Symptoms

Intervention Hierarchy (Ancestors)

BenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsQuinoxalines

Study Officials

  • Noah S Philip, MD

    Butler Hospital

    PRINCIPAL INVESTIGATOR

  • Lawrence H Price, MD

    Butler Hospital

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 4, 2007

First Posted

September 6, 2007

Study Start

October 1, 2007

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

July 21, 2015

Record last verified: 2015-07

Locations

US(1)