Smoking AbstinencePhase 1NCT00414752
Effects of AFQ056 and Nicotine in Reducing Cigarette Smoking
A Phase 1 study testing AFQ065 in people with Smoking Abstinence, run by Novartis at 1 site in Germany.
Trial summary
The purpose of this study is to assess the safety and efficacy of AFQ056 and nicotine compared to placebo on craving and withdrawal symptoms during voluntary smoking stoppage in healthy smokers. This study will also assess how the body interacts with AFQ056. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Abstinence
- What is being tested?
- AFQ065
- How many people
- 36 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2006to not given
- Phase
- Phase 1
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, male \& female subjects at least 18 years and ≤60 years of age
- In good health
- Female subjects must be surgically sterilized or postmenopausal.
- Current smokers not intending to quit
- Smoke on average 15 cigarettes or more and less than 60 cigarettes a day for the past year
- Fagerström Test for Nicotine Dependence score of at least 5 (indicates moderate to heavy smokers)
- Willing to refrain from smoking as required
- Written informed consent before entering the study
Who cannot join
- History of heart disease, septum defect and/or cardiac valves surgery; clinical relevant abnormality in the ECG
- Investigational drug treatment within 4 weeks prior to screening unless local health authority guidelines mandate a longer period
- Women of childbearing potential, pregnant or lactating females
- Donation of one unit (400mL) or more of blood, significant blood loss equaling at least one unit of blood within the past 2 months or a blood transfusion within 8 weeks prior to screening.
- Coffee consumption of more than 6 cups coffee/day
- Use of a medication within 2 weeks prior to Day 1 of each treatment period
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double Blind, Multiple Dose, Cross-Over, Placebo- and Active-Controlled Proof of Concept Study to Explore the Effects of AFQ056 and Nicotine (Active Comparator) on Craving and Withdrawal During Voluntary Smoking Abstinence in Healthy Smokers
The purpose of this study is to assess the safety and efficacy of AFQ056 and nicotine compared to placebo on craving and withdrawal symptoms during voluntary smoking stoppage in healthy smokers. This study will also assess how the body interacts with AFQ056.
- Conditions
- Smoking Abstinence
- Being tested
- AFQ065
- Keywords
- Smoking, abstinence, craving, smoker, AFQ056, nicotine, placebo
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AFQ065Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of craving by self-report questionnaires during 3 days of voluntary smoking stoppage
Secondary outcomes (6)
Reduction in symptoms of withdrawal during 3 days of voluntary smoking stoppage
Reduction in nicotine consumption during 6 days of free smoking
Reduction in impulsivity during 3 days of free smoking and during 3 days of voluntary smoking stoppage
Reduction in craving during 6 days of free smoking
Safety and tolerability of AFQ056 during treatment periods
Assessment of how the body interacts with AFQ056
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2006 (estimated)
- Study startSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking AbstinenceStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 36 participants
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis, Principal investigator, Investigator site
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00414752
- Sponsor's protocol ID
- CAFQ056A2109
- Status last verified
- Jun 2007
- First submitted
- 21 Dec 2006
- Last updated
- 22 Jun 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Multiple Dose, Cross-Over, Placebo- and Active-Controlled Proof of Concept Study to Explore the Effects of AFQ056 and Nicotine (Active Comparator) on Craving and Withdrawal During Voluntary Smoking Abstinence in Healthy Smokers
- ClinicalTrials.gov ID
- NCT00414752
- Acronym / sponsor ID
- CAFQ056A2109
- Conditions
- Smoking Abstinence
- Keywords
- Smoking, abstinence, craving, smoker, AFQ056, nicotine, placebo
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- First posted
- 22 Dec 2006 (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 purpose of this study is to assess the safety and efficacy of AFQ056 and nicotine compared to placebo on craving and withdrawal symptoms during voluntary smoking stoppage in healthy smokers. This study will also assess how the body interacts with AFQ056.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy, male \& female subjects at least 18 years and ≤60 years of age
- In good health
- Female subjects must be surgically sterilized or postmenopausal.
- Current smokers not intending to quit
- Smoke on average 15 cigarettes or more and less than 60 cigarettes a day for the past year
Key exclusion criteria (7 listed)
- History of heart disease, septum defect and/or cardiac valves surgery; clinical relevant abnormality in the ECG
- Investigational drug treatment within 4 weeks prior to screening unless local health authority guidelines mandate a longer period
- Women of childbearing potential, pregnant or lactating females
- Donation of one unit (400mL) or more of blood, significant blood loss equaling at least one unit of blood within the past 2 months or a blood transfusion within 8 weeks prior to screening.
- Coffee consumption of more than 6 cups coffee/day
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 |
|---|---|---|
| AFQ065 | Drug | – |
Primary outcome
Reduction of craving by self-report questionnaires during 3 days of voluntary smoking stoppage
6 secondary outcomes
Reduction in symptoms of withdrawal during 3 days of voluntary smoking stoppage
Reduction in nicotine consumption during 6 days of free smoking
Reduction in impulsivity during 3 days of free smoking and during 3 days of voluntary smoking stoppage
Reduction in craving during 6 days of free smoking
Safety and tolerability of AFQ056 during treatment periods
Assessment of how the body interacts with AFQ056
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 22 Jun 2007.
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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.
Novartis principal investigator
Investigator site
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AFQ065 in people with Smoking Abstinence, run by Novartis at 1 site in Germany.
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 8 inclusion and 7 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 22 Jun 2007. 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 Germany. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Reduction of craving by self-report questionnaires during 3 days of voluntary smoking stoppage. 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 22 Jun 2007.