Effects of Varenicline on Smoking Lapse in Smokers With and Without Schizophrenia

• Status: Completed
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

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 schizophrenia and control smokers using a randomized, double-blind, cross-over design. Smokers will be asked to stop smoking overnight; the next day the ability to resist smoking will be assessed in a laboratory smoking lapse paradigm. Measures of tobacco craving, reinforcement and withdrawal-related cognitive dysfunction will be correlated with time to lapse. The results could have significant clinical implications by identifying mechanisms by which smokers with schizophrenia are at more risk for relapse than the general population, leading to the development of more effective smoking cessation therapies.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Centre for Addiction and Mental Health
• Collaborator: Pfizer
• Treatments: Varenicline

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.