CravingPhase 4NCT01850953
Effects of Varenicline on Smoking Lapse in Smokers With and Without Schizophrenia
A Phase 4 study testing Varenicline in people with Craving and Smoking, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Craving, Smoking, Schizophrenia
- What is being tested?
- Varenicline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2013to May 2015
- Phase
- Phase 4
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Effects of Varenicline on Smoking Lapse in Smokers With and Without Schizophrenia: Implications for Treatment
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.
Read the 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.
- Conditions
- Craving, Smoking, Schizophrenia
- Being tested
- Varenicline, Placebo
- Keywords
- Varenicline, Schizophrenia, smoking, Lapse
- Medical subject headings
- Smoking, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VareniclineDrug
Also called Champix, Chantix
This is an approved smoking cessation medication.
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Sugar Pill | Placebo comparator | This is a sugar pill that will be used as a placebo comparator. Receives: Drug: Placebo |
| Varenicline | Active comparator | 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. Receives: Drug: Varenicline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Lapse
The objective of this study is to determine the effect of varenicline versus placebo, on time to lapse using a lapse paradigm.
Measured: Day 6 of week 1 and week 2
Secondary outcomes (4)
Cognitive Function
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
Measured: Day 6 of week 1 and week 2
Tobacco craving
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
Measured: Day 6 of week 1 and week 2
Tobacco withdrawal
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
Measured: Day 6 of week 1 and week 2
Tobacco Reinforcement
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
Measured: Day 6 of week 1 and week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2013 (estimated)
- Study startJun 2013
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CravingStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Tony George, Centre for Addiction and Mental Health
- Investigators
- Tony George, M.D., Study director, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01850953
- Sponsor's protocol ID
- 225/2012
- Other IDs
- GRAND 2012
- Status last verified
- Jan 2017
- First submitted
- 6 May 2013
- Last updated
- 27 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effects of Varenicline on Smoking Lapse in Smokers With and Without Schizophrenia: Implications for Treatment
- ClinicalTrials.gov ID
- NCT01850953
- Acronym / sponsor ID
- 225/2012
- Conditions
- Craving, Smoking, Schizophrenia
- Keywords
- Varenicline, Schizophrenia, smoking, Lapse
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Jun 2013
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 10 May 2013 (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.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sugar Pill | Placebo comparator | Drug: PlaceboThis is a sugar pill that will be used as a placebo comparator. |
| Varenicline | Active comparator | Drug: VareniclineVarenicline 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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]
Key exclusion criteria (8 listed)
- 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
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: Champix, ChantixThis is an approved smoking cessation medication. | Drug | Varenicline |
| Placebo | Drug | Sugar Pill |
Primary outcome
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.
4 secondary outcomes
Cognitive Function
Time frame: Day 6 of week 1 and week 2
Tobacco craving
Time frame: Day 6 of week 1 and week 2
Tobacco withdrawal
Time frame: Day 6 of week 1 and week 2
Tobacco Reinforcement
Time frame: Day 6 of week 1 and week 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2017.
- Information about research at the Centre for Addiction and Mental HealthLink provided by the sponsor.
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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.
Tony George, M.D. study director
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Varenicline in people with Craving and Smoking, run by Centre for Addiction and Mental Health at 1 site in Canada.
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 7 inclusion and 8 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: finished, as of the sponsor's last update on 27 Jan 2017. 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 Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to Lapse (time frame: Day 6 of week 1 and week 2). 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 27 Jan 2017.