Status:
COMPLETED
Effects of Varenicline on Smoking Lapse in Smokers With and Without Schizophrenia
Lead Sponsor:
Centre for Addiction and Mental Health
Collaborating Sponsors:
Pfizer
Conditions:
Craving
Smoking
Eligibility:
All Genders
18-55 years
Phase:
PHASE4
Brief Summary
The objective of this study is to determine the mechanisms by which varenicline, an effective smoking cessation treatment, protects against relapse. Varenicline will be administered in smokers with sc...
Detailed Description
One way to facilitate medication development for smoking cessation is through the use of human laboratory paradigms that can provide an efficient, cost-effective and mechanistic evaluation of a medica...
Eligibility Criteria
Inclusion
- Cigarette Smokers (smoke ≥ 10 cigarettes per day)
- non-treatment seeking (i.e., not trying to quit as indicated by \<7 on the contemplation ladder)
- aged 18-55
- Intelligence Quotient (IQ) ≥80 on the Wechsler Test of Adult Reading \[89\]
- Fagerstrom Test of Nicotine Dependence (FTND) ≥4 \[90\]
- Patients must meet Structured Clinical Interview for the diagnostic and Statistical Manual for Mental Disorders (SCID-IV) diagnosis criteria for schizophrenia or schizoaffective disorder; be in stable remission from positive symptoms of psychosis as judged by a Positive and Negative Syndrome Scale (PANSS) positive score total score \<70, and receiving a stable dose of antipsychotics for \>1month.
- Control participants will not be taking any psychotropic medications at the time of enrollment and will not meet diagnostic criteria for any Axis I disorder, except past history of major depression or an anxiety disorder if in remission for at least one year.
Exclusion
- substance use (except nicotine or caffeine) in the last month
- a history of alcohol/drug abuse in the 3 months before study enrollment
- use of opioids (meperidine, oxycodone, methadone, etc)
- current use of smoking cessation aids (e.g., nicotine replacement therapy, bupropion or varenicline
- pregnancy or nursing
- a history of renal insufficiency or a hypersensitivity to varenicline (Champix®)
- a history of neurological illness like epilepsy or medical condition known to significantly influence neurocognitive function
- any other medical condition deemed relevant by the Qualified Investigator.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01850953
Start Date
June 1 2013
End Date
May 1 2015
Last Update
January 27 2017
Active Locations (1)
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1
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M5S 2S1