NCT02129387

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
115

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2014

Longer than P75 for all trials

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

April 1, 2014

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

April 30, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 2, 2014

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
Last Updated

November 1, 2022

Status Verified

October 1, 2022

Enrollment Period

7.6 years

First QC Date

April 30, 2014

Last Update Submit

October 28, 2022

Conditions

Keywords

NicotineSmoking ProgressionEEGYoung adultsLight smokersrs1051730 genotype

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • reason for change in smoke rate

    18 months after initial assessment

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Community sample of young light smokers

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southern Illinois University Carbondale Department of Psychology

Carbondale, Illinois, 62901-6502, United States

Location

Related Publications (2)

  • Gunn MP, Rose GM, Whitton AE, Pizzagalli DA, Gilbert DG. Smoking Progression and Nicotine-Enhanced Reward Sensitivity Predicted by Resting-State Functional Connectivity in Salience and Executive Control Networks. Nicotine Tob Res. 2024 Sep 23;26(10):1305-1312. doi: 10.1093/ntr/ntae084.

  • Whitton AE, Rabinovich NE, Lindt JD, Pergadia ML, Pizzagalli DA, Gilbert DG. Genetic and Depressive Traits Moderate the Reward-Enhancing Effects of Acute Nicotine in Young Light Smokers. Nicotine Tob Res. 2021 Aug 29;23(10):1779-1786. doi: 10.1093/ntr/ntab072.

Biospecimen

Retention: SAMPLES WITH DNA

blood, saliva

MeSH Terms

Conditions

Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • David G Gilbert, PhD

    Southern Illinois University Carbondale

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2014

First Posted

May 2, 2014

Study Start

April 1, 2014

Primary Completion

October 31, 2021

Study Completion

November 30, 2021

Last Updated

November 1, 2022

Record last verified: 2022-10

Locations