Tobacco AddictionPhase 2NCT01785147
Efficacy and Safety of BP1.4979 in Smoking Cessation
A Phase 2 study testing BP1.4979 in people with Tobacco Addiction, run by Bioprojet at 1 site in France.
Trial summary
Clinical study which aim is to assess in heavy smokers willing to quit smoking the efficacy and the safety profile of BP1.4979 for smoking cessation on the total abstinence measured by subject diary and confirmed by exhaled CO (abstinent < 10 ppm). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tobacco Addiction
- What is being tested?
- BP1.4979
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 219 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2013to Oct 2014
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Main inclusion Criteria:
- a smoking history of at least 10 years
- subject smoking at least 15 cigarettes per day at the time being and for at least 30 days before selection.
- having already made at least 2 attempts to stop
- with no period of abstinence > 3 months in the previous year
- FTND ≥ 7
Main exclusion Criteria:
- any significant psychiatric illness or mood disorder, assessed by the BDI
- HAD scale (A + D ≥ 19, the day of the selection and inclusion)
- AUDIT ≥ 8
- subject smoking cigars or pipes exclusively
- subject taking any antismoking medication and/ or Nicotine Replacement Therapy (NRT) in the previous month.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Placebo Controlled Trial Assessing the Efficacy and Safety of BP1.4979 in Smoking Cessation
Clinical study which aim is to assess in heavy smokers willing to quit smoking the efficacy and the safety profile of BP1.4979 for smoking cessation on the total abstinence measured by subject diary and confirmed by exhaled CO (abstinent < 10 ppm).
Read the detailed description
BP1.4979 is a novel compound with promising efficacy on smoker which have been assessed on phase I studies.
This is a multicenter,randomized, double blind, placebo controlled, phase IIb trial with parallel group to assess safety and efficacy of BP1.4979 in smoker.
- Conditions
- Tobacco Addiction
- Being tested
- BP1.4979, Placebo
- Keywords
- Tobacco addition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BP1.4979Drug
BP1.4979 at 3mg, 10mg, 15mg or placebo during 3 months.
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| BP1.4979 3mg | Experimental | BP1.4979 3mg during 3 months Receives: Drug: BP1.4979 |
| BP1.4979 10mg | Experimental | BP1.4979 10mg during 3 months Receives: Drug: BP1.4979 |
| BP1.4979 15mg | Experimental | BP1.4979 15mg during 3 months Receives: Drug: BP1.4979 |
| Placebo | Placebo comparator | Placebo during 3 months Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
4-week prolonged abstinence from smoking cigarettes
The primary measure of efficacy will be 4-week prolonged abstinence from smoking cigarettes at the end of 12-week double-blind treatment phase (i.e. from V3 to V4).
The continuous abstinence measured by subject diary and verified by exhaled CO (abstinent < 10 ppm) will define response to the treatment.
Measured: 4 weeks
Secondary outcomes (3)
7-day tobacco Point Prevalence Abstinence (PPA)
7-day tobacco Point Prevalence Abstinence (PPA) will be assessed at each visit by analysis of cigarettes consumption using self-report diaries and measurement of exhaled CO
Measured: 7 days
Number of adverse events
Assessment of safety thanks to the number and clinical evaluation of the adverse events.
Measured: 26 weeks
Vital signs measures
Vital signs (measurement of heart rate, blood pressure, and body weight) will be assessed at each study visit, thanks to physical examinations (V0 and V4), ECG and laboratory tests (blood chemistry, haematology, urinanalysis tests, prolactin dosage) at screening (V0), after 4-week treatment (V2) and at V4.
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionJul 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco AddictionStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioprojet
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Henri-Jean AUBIN, MD, Ph.D, Principal investigator, Hôpital Paul Brousse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01785147
- Sponsor's protocol ID
- P12-01 / BP1.4979
- Other IDs
- 2012-002731-28
- Status last verified
- Jan 2015
- First submitted
- 5 Feb 2013
- Last updated
- 21 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Placebo Controlled Trial Assessing the Efficacy and Safety of BP1.4979 in Smoking Cessation
- ClinicalTrials.gov ID
- NCT01785147
- Acronym / sponsor ID
- P12-01 / BP1.4979
- Conditions
- Tobacco Addiction
- Keywords
- Tobacco addition
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- BioprojetUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 7 Feb 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.
Clinical study which aim is to assess in heavy smokers willing to quit smoking the efficacy and the safety profile of BP1.4979 for smoking cessation on the total abstinence measured by subject diary and confirmed by exhaled CO (abstinent < 10 ppm).
Detailed description
BP1.4979 is a novel compound with promising efficacy on smoker which have been assessed on phase I studies.
This is a multicenter,randomized, double blind, placebo controlled, phase IIb trial with parallel group to assess safety and efficacy of BP1.4979 in smoker.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BP1.4979 3mg | Experimental | Drug: BP1.4979BP1.4979 3mg during 3 months |
| BP1.4979 10mg | Experimental | Drug: BP1.4979BP1.4979 10mg during 3 months |
| BP1.4979 15mg | Experimental | Drug: BP1.4979BP1.4979 15mg during 3 months |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo during 3 months |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| BP1.4979BP1.4979 at 3mg, 10mg, 15mg or placebo during 3 months. | Drug | BP1.4979 10mg, BP1.4979 15mg, BP1.4979 3mg |
| Placebo | Drug | Placebo |
Primary outcome
4-week prolonged abstinence from smoking cigarettes
Time frame: 4 weeks
The primary measure of efficacy will be 4-week prolonged abstinence from smoking cigarettes at the end of 12-week double-blind treatment phase (i.e. from V3 to V4). The continuous abstinence measured by subject diary and verified by exhaled CO (abstinent < 10 ppm) will define response to the treatment.
3 secondary outcomes
7-day tobacco Point Prevalence Abstinence (PPA)
Time frame: 7 days
Number of adverse events
Time frame: 26 weeks
Vital signs measures
Time frame: 26 weeks
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 21 Jan 2015.
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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.
Henri-Jean AUBIN, MD, Ph.D principal investigator
Hôpital Paul Brousse
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 BP1.4979 in people with Tobacco Addiction, run by Bioprojet 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?
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 21 Jan 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. 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 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?
4-week prolonged abstinence from smoking cigarettes (time frame: 4 weeks). 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 21 Jan 2015.