Healthy Highly Dependant SmokersPhase 2NCT02357888
Assessment of V0018 2.5 mg Effect on Craving
A Phase 2 study testing V0018 in people with Healthy Highly Dependant Smokers, run by Pierre Fabre Medicament at 1 site in France.
Trial summary
The purpose of this study is to evaluate the reduction of craving and its time course after administration of V0018 2.5 mg compared to placebo in healthy highly dependant smokers. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Highly Dependant Smokers
- What is being tested?
- V0018
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2015to May 2015
- Phase
- Phase 2
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female aged 18 to 64 years
- Smoking ≥ 20 cigarettes/day continuously for the last two years
- With a first cigarette smoked within 30 min after waking
- Not currently in the process of quitting smoking
Who cannot join
- Related to pathologies
- Current or recurrent buccal lesions which, in the opinion of the investigator, would interfere with the assessment of the different parameters
- Hyposalivation or asialia
- Intolerance to lactose, or any pathology that could cause endogenous production of carbon monoxide (CO)
- Related to treatments
- Use of antidepressants within the last three months
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- Use of sedatives, hypnotics, tranquilizers or any other addictive agents within the last 3 months
- Routine use of tobacco other than cigarettes
- Regular use for more than one week of any treatment for smoking cessation (gum, patch, inhaler, lozenge, tablet, bupropion, varenicline) and other smokeless tobacco products (including e-cigarettes) within three months
- History of hypersensitivity to nicotine, peanut, soya or to any of the excipients of study treatment
- Intolerance to fructose
- History of phenylketonuria (aspartame)
- For women of childbearing potential:
- Is pregnant or in post-partum period or a nursing mother
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-blind, Randomized, Placebo-controlled, Cross-over Study of the Effect of a 2.5 mg Nicotine Lozenge on Smoking Craving
The purpose of this study is to evaluate the reduction of craving and its time course after administration of V0018 2.5 mg compared to placebo in healthy highly dependant smokers.
- Conditions
- Healthy Highly Dependant Smokers
- Being tested
- V0018, Placebo
- Keywords
- Nicotine replacement therapy, craving
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V0018Drug
Oromucosal - Single dose
PlaceboDrug
Oromucosal - Single dose
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | Treatment group sequence: Test Product on Day 1 and Placebo on Day 2 Receives: Drug: V0018; Drug: Placebo |
| Sequence 2 | Experimental | Treatment group sequence: Placebo on Day 1 and Test Product on Day 2 Receives: Drug: V0018; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire for Smoking Urges Brief (QSU-Brief) (10 items)
Change from study baseline to 15 minutes after treatment intake for the QSU-brief total score and demonstrate any earlier effect.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2015 (estimated)
- Study startFeb 2015
- 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 Healthy Highly Dependant SmokersStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Medicament
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Françoise MD TONNER, Study director, Pierre Fabre Medicament
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02357888
- Sponsor's protocol ID
- V00018 PC 2 06
- Other IDs
- 2014-004387-38, 2014
- Status last verified
- Oct 2015
- First submitted
- 3 Feb 2015
- Last updated
- 8 Oct 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomized, Placebo-controlled, Cross-over Study of the Effect of a 2.5 mg Nicotine Lozenge on Smoking Craving
- ClinicalTrials.gov ID
- NCT02357888
- Acronym / sponsor ID
- V00018 PC 2 06
- Conditions
- Healthy Highly Dependant Smokers
- Keywords
- Nicotine replacement therapy, craving
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Pierre Fabre MedicamentIndustry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 6 Feb 2015 (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 evaluate the reduction of craving and its time course after administration of V0018 2.5 mg compared to placebo in healthy highly dependant smokers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: V0018, Drug: PlaceboTreatment group sequence: Test Product on Day 1 and Placebo on Day 2 |
| Sequence 2 | Experimental | Drug: V0018, Drug: PlaceboTreatment group sequence: Placebo on Day 1 and Test Product on Day 2 |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male and female aged 18 to 64 years
- Smoking ≥ 20 cigarettes/day continuously for the last two years
- With a first cigarette smoked within 30 min after waking
- Not currently in the process of quitting smoking
Key exclusion criteria (14 listed)
- Related to pathologies
- Current or recurrent buccal lesions which, in the opinion of the investigator, would interfere with the assessment of the different parameters
- Hyposalivation or asialia
- Intolerance to lactose, or any pathology that could cause endogenous production of carbon monoxide (CO)
- Related to treatments
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 |
|---|---|---|
| V0018Oromucosal - Single dose | Drug | Sequence 1, Sequence 2 |
| PlaceboOromucosal - Single dose | Drug | Sequence 1, Sequence 2 |
Primary outcome
Questionnaire for Smoking Urges Brief (QSU-Brief) (10 items)
Time frame: 15 minutes
Change from study baseline to 15 minutes after treatment intake for the QSU-brief total score and demonstrate any earlier effect.
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 8 Oct 2015.
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.
Françoise MD TONNER study director
Pierre Fabre Medicament
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing V0018 in people with Healthy Highly Dependant Smokers, run by Pierre Fabre Medicament at 1 site in France.
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 4 inclusion and 14 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 8 Oct 2015. 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 France. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Questionnaire for Smoking Urges Brief (QSU-Brief) (10 items) (time frame: 15 minutes). 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 8 Oct 2015.