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EEG & Behavioral Predictors of Changes in Smoking Trajectories in Young Light Smokers

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ClinicalTrials.gov Identifier: NCT02129387
Recruitment Status : Recruiting
First Posted : May 2, 2014
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
Southern Illinois University Carbondale

Brief Summary:
The purpose of the proposal is to identify new predictors of smoking progression in young light smokers (YLS: 18-25 years & cpd < 5) using an 18-month longitudinal design and to relate these predictors of progression to the genetic profile most highly associated with smoking progression. A number of novel predictors will be assessed in 128 YLS. Predictors will include individual differences (IDs) in EEG, reward sensitivity, attentional performance, and mood during abstinence and in response to standardized and to self-selected acute nicotine doses (ANIC), as well as genetically influenced affective traits, and smoking history. The associations of a compelling genetic functional variant polymorphism, rs16969968, in the alpha5 nicotinic receptor subunit will also be related to smoking progression and the novel predictors. The study is expected to provide insights into IDs in mechanisms and predictors that contribute to smoking trajectories in YLS and thereby lead to targeted pharmacotherapy and behavioral interventions for at-risk YLS.

Condition or disease
Nicotine Dependence

Detailed Description:
The purpose of the proposal is to identify new biobehavioral endophenotypes that predict smoking progression in young light smokers (YLS: 18-25 years & cpd < 5) using an 18-month longitudinal design and to relate these endophenotypes and progression to the genetic profile most highly associated with smoking progression. A number of novel predictors will be assessed in 128 YLS. Predictors will include individual differences (IDs) in EEG, reward sensitivity, attentional performance, and mood during abstinence and in response to standardized and to self-selected acute nicotine doses (ANIC), as well as genetically influenced affective traits, and smoking history. The associations of a compelling genetic functional variant polymorphism, rs16969968, in the alpha5 nicotinic receptor subunit will also be related to smoking progression and the novel predictors. The study is expected to provide insights into IDs in mechanisms and endophenotypes that contribute to smoking trajectories in YLS and thereby lead to targeted pharmacotherapy and behavioral interventions for at-risk YLS.

Study Type : Observational
Estimated Enrollment : 128 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: EEG & Behavioral Predictors of Changes in Smoking Trajectories in Young Light Smokers
Study Start Date : April 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking




Primary Outcome Measures :
  1. change in smoking and salivary cotinine concentration [ Time Frame: 18 months ]
    Change in smoking and salivary cotinine concentration from baseline to 18 months will be assessed at 3 month intervals-- 3, 6, 9, 12, 15, and 18 months after initial assessments.


Secondary Outcome Measures :
  1. reason for change in smoke rate [ Time Frame: 18 months after initial assessment ]
    Self-reported reasons for changing smoking or for continuing to smoke at the same rate will be assessed a 3-month intervals until 18 months after baseline assessment.


Biospecimen Retention:   Samples With DNA
blood, saliva


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Community sample of young light smokers
Criteria

Inclusion Criteria:

  • smokers of 3 to 30 cigarettes per week for past 6 months

Exclusion Criteria:

  • Smoking fewer than 3 or more than 30 tobacco cigarettes per week
  • Never smoked more than 30 cigarettes per week
  • Psychoactive drug use other than caffeine or occasional marijuana
  • Current serious psychiatric diagnosis (e.g., major depressive disorder)
  • Recent drug dependence
  • Left-handed
  • Color blind

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02129387


Contacts
Contact: David G Gilbert, PhD 618-453-3527 dgilbert@siu.edu
Contact: Norka E Rabinovich, BA 618-453-3527 norkar@siu.edu

Locations
United States, Illinois
Southern Illinois University Carbondale Department of Psychology Recruiting
Carbondale, Illinois, United States, 62901-6502
Contact: David G Gilbert, PhD    618-453-3527    dgilbert@siu.edu   
Contact: Norka E Rabinovich, BA    618-453-3527    norkar@siu.edu   
Principal Investigator: David G Gilbert, PhD         
Sub-Investigator: Michele Pergadia, PhD         
Sub-Investigator: Diego Pizzagalli, PhD         
Sponsors and Collaborators
Southern Illinois University Carbondale
Investigators
Principal Investigator: David G Gilbert, PhD Southern Illinois University Carbondale

Responsible Party: Southern Illinois University Carbondale
ClinicalTrials.gov Identifier: NCT02129387     History of Changes
Other Study ID Numbers: 1R01DA036032-01 ( U.S. NIH Grant/Contract )
First Posted: May 2, 2014    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018

Keywords provided by Southern Illinois University Carbondale:
Nicotine
Smoking Progression
EEG
Young adults
Light smokers
rs1051730 genotype

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders