NCT01785147

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
219

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

February 5, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 7, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

January 21, 2015

Status Verified

January 1, 2015

Enrollment Period

1.4 years

First QC Date

February 5, 2013

Last Update Submit

January 20, 2015

Conditions

Tobacco Addiction

Keywords

Tobacco addition

Outcome Measures

Primary Outcomes (1)

  • 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.

    4 weeks

Secondary Outcomes (3)

  • 7-day tobacco Point Prevalence Abstinence (PPA)

    7 days

  • Number of adverse events

    26 weeks

  • Vital signs measures

    26 weeks

Study Arms (4)

BP1.4979 3mg

EXPERIMENTAL

BP1.4979 3mg during 3 months

Drug: BP1.4979

BP1.4979 10mg

EXPERIMENTAL

BP1.4979 10mg during 3 months

Drug: BP1.4979

BP1.4979 15mg

EXPERIMENTAL

BP1.4979 15mg during 3 months

Drug: BP1.4979

Placebo

PLACEBO COMPARATOR

Placebo during 3 months

Drug: Placebo

Interventions

BP1.4979DRUG

BP1.4979 at 3mg, 10mg, 15mg or placebo during 3 months.

BP1.4979 10mgBP1.4979 15mgBP1.4979 3mg
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • any significant psychiatric illness or mood disorder, assessed by the BDI
  • AUDIT ≥ 8
  • subject smoking cigars or pipes exclusively
  • subject taking any antismoking medication and/ or Nicotine Replacement Therapy (NRT) in the previous month.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Paul Brousse

Villejuif, Île-de-France Region, 94800, France

Location

Study Officials

  • Henri-Jean AUBIN, MD, Ph.D

    Hôpital Paul Brousse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2013

First Posted

February 7, 2013

Study Start

February 1, 2013

Primary Completion

July 1, 2014

Study Completion

October 1, 2014

Last Updated

January 21, 2015

Record last verified: 2015-01

Locations

FR(1)