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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02129387
Other study ID # 1R01DA036032-01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 2014
Est. completion date November 30, 2021

Study information

Verified date October 2022
Source Southern Illinois University Carbondale
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 115
Est. completion date November 30, 2021
Est. primary completion date October 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 25 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Southern Illinois University Carbondale Department of Psychology Carbondale Illinois

Sponsors (1)

Lead Sponsor Collaborator
Southern Illinois University Carbondale

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary change in smoking and salivary cotinine concentration 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. 18 months
Secondary reason for change in smoke rate 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. 18 months after initial assessment
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