SmokingNCT00525928
Mood and Anti-craving Effects of Varenicline in Psychiatric Inpatients
A study testing varenicline in people with Smoking and Depressive Disorder, run by Butler Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Smoking, Depressive Disorder
- What is being tested?
- varenicline
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Oct 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admission to Butler Hospital during study period.
- Current tobacco users ages 18-65.
- Able to give written, informed consent.
Who cannot join
- Past adverse reaction to varenicline.
- Treatment with varenicline on admission to Butler Hospital.
- Renal failure or dialysis
- Current pregnancy or breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Response to Open-label Treatment With Varenicline in Psychiatric Inpatients
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.
Read the 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.
- Conditions
- Smoking, Depressive Disorder
- Being tested
- varenicline
- Keywords
- craving, smoking, depression
- Medical subject headings
- Smoking, Depressive Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vareniclineDrug
Also called Chantix
varenicline 0.5mg daily for days 1-3, 0.5mg twice daily for days 3-7, then 1mg twice daily for length of hospitalization
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement in Quick Inventory of Depressive Symptoms (QIDS-SR)
Measured: duration of hospitalization
improvement in Minnesota Nicotine Withdrawal Scale
Measured: 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)
Measured: duration of hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2007 (estimated)
- Study startOct 2007
- Primary completionOct 2008
- Study completionOct 2008 (estimated)
Why it stopped: insufficient recuirment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Butler Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Brown University
- Investigators
- Noah S Philip, MD, Principal investigator, Butler HospitalLawrence H Price, MD, Study director, Butler Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00525928
- Sponsor's protocol ID
- 0707-003
- Status last verified
- Jul 2015
- First submitted
- 4 Sep 2007
- Last updated
- 21 Jul 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Response to Open-label Treatment With Varenicline in Psychiatric Inpatients
- ClinicalTrials.gov ID
- NCT00525928
- Acronym / sponsor ID
- 0707-003
- Conditions
- Smoking, Depressive Disorder
- Keywords
- craving, smoking, depression
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: insufficient recuirment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Butler HospitalUniversity, hospital or other
- Collaborators
- Brown University
- Study start
- Oct 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (estimated)
- First posted
- 6 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Admission to Butler Hospital during study period.
- Current tobacco users ages 18-65.
- Able to give written, informed consent.
Key exclusion criteria (4 listed)
- Past adverse reaction to varenicline.
- Treatment with varenicline on admission to Butler Hospital.
- Renal failure or dialysis
- Current pregnancy or breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vareniclineAlso: Chantixvarenicline 0.5mg daily for days 1-3, 0.5mg twice daily for days 3-7, then 1mg twice daily for length of hospitalization | Drug | – |
Primary outcome
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)
1 secondary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noah S Philip, MD principal investigator
Butler Hospital
Lawrence H Price, MD study director
Butler Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing varenicline in people with Smoking and Depressive Disorder, run by Butler Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improvement in Quick Inventory of Depressive Symptoms (QIDS-SR) (time frame: duration of hospitalization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2015.