- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01850953
Effects of Varenicline on Smoking Lapse in Smokers With and Without Schizophrenia
Evaluating the Effects of Varenicline on Smoking Lapse in Smokers With and Without Schizophrenia: Implications for Treatment
Study Overview
Status
Conditions
Intervention / Treatment
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 medication signal on smoking behavior and bridge pre-clinical studies and costly clinical trials. This study will take advantage of the recent development and validation of a smoking lapse procedure to evaluate the effects of varenicline in smokers with and without schizophrenia. We will extend our recent work with varenicline by relating its effects on reinforcement, craving and cognition to clinical outcome (i.e., lapse - a strong predictor of relapse). It is pertinent to study smokers with schizophrenia because as smoking rates decline in the general population we will be left with a group of'hardcore' smokers for whom current smoking cessation strategies have limited efficacy.
The objective of this study is to determine the effect of varenicline versus placebo, on time to lapse, as a function of craving, reinforcement and cognitive dysfunction, in smokers with and without schizophrenia. We hypothesize that:
- Smokers with schizophrenia will have reduced ability to resist smoking during the placebo condition compared to controls; and secondarily, this will be related to the higher levels of cognitive dysfunction during abstinence.
- Varenicline will increase the ability to resist smoking in both control and schizophrenia smokers; and secondarily, this will be mediated via its effects on cognition in smokers with schizophrenia, and its effects on craving in control smokers.
The exploratory aims are to determine:
- Varenicline's effect on cue-reactivity in smokers with and without schizophrenia and its relationship to time to lapse.
- Varenicline's effects on tobacco reinforcement and its relationship to ad lib smoking in the lapse period
The current study will advance the development of tobacco addiction treatments in the following ways: 1) Identification of mechanisms by which varenicline facilitates abstinence in different subtypes of smokers (schizophrenia vs. controls) is critical to improve treatment response. 2) Identification of predictors of relapse in different subtypes of smokers (schizophrenia vs. controls) could guide future medication development efforts. 3) Relating measures of tobacco abstinence and addiction collected in the laboratory to proxy measures of treatment outcome (i.e., smoking lapse) will provide further validation that evaluation of medications in such paradigms is a useful and cost-effective screening strategy. 4) Our approach could also be used to identify smokers most at risk for tobacco abstinence symptoms who would benefit from treatments targeting the most prominent aspects of withdrawal. This could lead to improved health outcomes in smokers.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5S 2S1
- Centre for Addiction and Mental Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Sugar Pill
This is a sugar pill that will be used as a placebo comparator.
|
|
ACTIVE_COMPARATOR: Varenicline
Varenicline will be titrated to steady-state levels of 2mg/day over 4 days (0.5mg BID for day 1 and 1.0mg BID for days 2-4) before testing at 2mg/day on days 5 and 6.
|
This is an approved smoking cessation medication.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to Lapse
Time Frame: Day 6 of week 1 and week 2
|
The objective of this study is to determine the effect of varenicline versus placebo, on time to lapse using a lapse paradigm.
|
Day 6 of week 1 and week 2
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cognitive Function
Time Frame: Day 6 of week 1 and week 2
|
The secondary objectives of this study are to determine the effect of varenicline versus placebo, on time to lapse, as a function of craving, reinforcement and cognitive dysfunction, in smokers with and without schizophrenia
|
Day 6 of week 1 and week 2
|
Tobacco craving
Time Frame: Day 6 of week 1 and week 2
|
The secondary objectives of this study are to determine the effect of varenicline versus placebo, on time to lapse, as a function of craving, reinforcement and cognitive dysfunction, in smokers with and without schizophrenia
|
Day 6 of week 1 and week 2
|
Tobacco withdrawal
Time Frame: Day 6 of week 1 and week 2
|
The secondary objectives of this study are to determine the effect of varenicline versus placebo, on time to lapse, as a function of craving, reinforcement and cognitive dysfunction, in smokers with and without schizophrenia
|
Day 6 of week 1 and week 2
|
Tobacco Reinforcement
Time Frame: Day 6 of week 1 and week 2
|
The secondary objectives of this study are to determine the effect of varenicline versus placebo, on time to lapse, as a function of craving, reinforcement and cognitive dysfunction, in smokers with and without schizophrenia
|
Day 6 of week 1 and week 2
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Tony George, M.D., Centre for Addiction and Mental Health
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 225/2012
- GRAND 2012 (OTHER_GRANT: Pfizer)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Smoking
-
University of Southern CaliforniaAmerican Cancer Society, Inc.CompletedSmoking | Smoking Cessation | Smoking, Cigarette | Smoking Behaviors | Cessation, SmokingUnited States
-
University of VirginiaRecruitingSmoking | Smoking Cessation | Smoking Reduction | Smoking, Tobacco | Smoking, Cigarette | Quitting SmokingUnited States
-
University GhentRecruitingSmoking | Smoking Tobacco | Smoking Prevention | Smoking CigaretteBelgium
-
Medical University of South CarolinaCompletedSmoking | Smoking Cessation | Smoking, Tobacco | Smoking, CigaretteUnited States
-
Columbia UniversityNational Cancer Institute (NCI)RecruitingSmoking | Smoking Cessation | Smoking Reduction | Smoking BehaviorsUnited States
-
National Cancer Institute (NCI)CompletedSmoking | Smoking Cessation | Cigarette Smoking | Tobacco, SmokingUnited States
-
Maastricht University Medical CenterThe Investigative Desk; SEO Amsterdam Economics; IVO Research InstituteEnrolling by invitationSmoking Cessation | Smoking Reduction | Smoking, Tobacco | Smoking BehaviorsNetherlands
-
Jennifer Marler, MDCompletedSmoking Cessation | Smoking Reduction | Smoking, Tobacco | Smoking BehaviorsUnited States
-
Medical University of South CarolinaRecruitingSmoking | Smoking Cessation | Tobacco Smoking | Cigarette SmokingUnited States
-
Abramson Cancer Center at Penn MedicineNational Cancer Institute (NCI); New York University; Stanford UniversityRecruitingSmoking | Smoking, Tobacco | Smoking, CigaretteUnited States
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States