NCT01554436

Brief Summary

The low overall effectiveness of available smoking cessation treatment so far, indicate the need for new and more efficacious ways to help smokers maintain abstinence. Smokers are a highly heterogeneous population. Identification of individual characteristics that predict success in smoking cessation is highly desirable to allow designing more specific strategies in order to enhance success in quitting tobacco.The main objective of this study is to assess whether the presence of certain neuropsychological deficits found before the initiation of smoking cessation is associated with a greater relapse rate.The secondary objectives concern how neuropsychological performance are involved in motivation and craving in the whole sample of smokers or in subsample. Long-term perspective is to define clinical or neuropsychological factors associated with agood or poor prognosis for success and provived more specific and therefore more effective care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
135

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2008

Typical duration for phase_4

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2012

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 15, 2012

Completed
Last Updated

December 31, 2014

Status Verified

March 1, 2012

Enrollment Period

2.4 years

First QC Date

February 24, 2012

Last Update Submit

December 30, 2014

Conditions

Smoking CessationNicotine Dependence

Keywords

SmokingNeuropsychologyAbstinencePrognosisNicotine Dependence, Cigarettes, with Other Nicotine-induced Disorders

Outcome Measures

Primary Outcomes (1)

  • neuropsychological test

    There primary outcome is to assess if smokers with low attentional level (defined has the median of the sample in Nback and RVIP tasks) are at higher level of relapse at 6 months.

    6 months

Secondary Outcomes (2)

  • Interactions neuropsychological performance and clinical conditions in patients with psychiatric desease

    6 months

  • Interactions neuropsychological performance and clinical conditions in patients with hyperactivity disorders

    6 months

Study Arms (1)

patients in smoking cessation

EXPERIMENTAL

patients in smoking cessation

Behavioral: neuropsychological assessment

Interventions

neuropsychological assessmentBEHAVIORAL

The main criterion of evaluation of the smoking abstinence will be made by the measure of the rate of carbon monoxide (CO) in the expired air between the study start and during the study until 6 months after inclusion. The secondary criteria of evaluation are criteria of neuropsychological order, namely the performances in the tests listed: result of NART test,Continuous Performance Test (CPT), Trail Making test, Stroop test, Iowa gambling task. (IGT), Hayling test, N back test, fluence verbal test

patients in smoking cessation

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Men and women aged 18-60 years old
  • Patient applying for withdrawal regardless of the number of P / A, the length of smoking.
  • Patient with nicotine dependence (Fagerstrom Test score \> or = 3)
  • Patient able to understand the nature, purpose and methodology of the study
  • Patient who gave written informed consent to participate in the study
  • Patient agree to cooperate in the clinical and neuropsychological evaluation
  • Patient affiliated to a French social security system

You may not qualify if:

  • Patient with a physical disease being able to interact with the cognitive performances: dysthyroidies, pituitary adenomas, neurodegenerative diseases, Parkinson's disease, neoplastic diseases with intellectual location, the central neurological disorders, the cranial traumas.
  • Patient in the incapacity to answer at neuropsychological tests
  • Patient who can't go back at visits in 6 months
  • Pregnancy women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Montpellier

Montpellier, 34295, France

Location

Related Publications (1)

  • Flaudias V, Picot MC, Lopez-Castroman J, Llorca PM, Schmitt A, Perriot J, Georgescu V, Courtet P, Quantin X, Guillaume S. Executive Functions in Tobacco Dependence: Importance of Inhibitory Capacities. PLoS One. 2016 Mar 8;11(3):e0150940. doi: 10.1371/journal.pone.0150940. eCollection 2016.

    PMID: 26953688DERIVED

MeSH Terms

Conditions

Smoking CessationTobacco Use DisorderSmoking

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and Activities

Study Officials

  • Guillaume Sébastien, MD

    CHRU de Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2012

First Posted

March 15, 2012

Study Start

December 1, 2008

Primary Completion

May 1, 2011

Study Completion

November 1, 2011

Last Updated

December 31, 2014

Record last verified: 2012-03

Locations

FR(1)