Nicotine DependenceNCT02129387
EEG & Behavioral Predictors of Changes in Smoking Trajectories in Young Light Smokers
An observational study of Nicotine Dependence, run by Southern Illinois University Carbondale at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence
- How many people
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to 30 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Community sample of young light smokers
Who may be able to join
- smokers of 3 to 30 cigarettes per week for past 6 months
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Southern Illinois University Carbondale Department of Psychology
Carbondale, Illinois, 62901-6502
About this study
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.
Read the 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.
- Conditions
- Nicotine Dependence
- Keywords
- Nicotine, Smoking Progression, EEG, Young adults, Light smokers, rs1051730 genotype
- Medical subject headings
- Tobacco Use Disorder
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Secondary outcomes (1)
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.
Measured: 18 months after initial assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2014 (estimated)
- Study startApr 2014
- Primary completion31 Oct 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southern Illinois University Carbondale
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David G Gilbert, PhD, Principal investigator, Southern Illinois University Carbondale
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02129387
- Sponsor's protocol ID
- 1R01DA036032-01
- Status last verified
- Oct 2022
- First submitted
- 30 Apr 2014
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 38624067Whitton 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.
PubMed 33844007
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EEG & Behavioral Predictors of Changes in Smoking Trajectories in Young Light Smokers
- ClinicalTrials.gov ID
- NCT02129387
- Acronym / sponsor ID
- 1R01DA036032-01
- Conditions
- Nicotine Dependence
- Keywords
- Nicotine, Smoking Progression, EEG, Young adults, Light smokers, rs1051730 genotype
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Southern Illinois University CarbondaleUniversity, hospital or other
- Study start
- Apr 2014 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 2 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Community sample of young light smokers
Key inclusion criteria (1 listed)
- smokers of 3 to 30 cigarettes per week for past 6 months
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
reason for change in smoke rate
Time frame: 18 months after initial assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Derived from this study: PubMed 38624067Gunn 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.
- Derived from this study: PubMed 33844007Whitton 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David G Gilbert, PhD principal investigator
Southern Illinois University Carbondale
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nicotine Dependence, run by Southern Illinois University Carbondale at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in smoking and salivary cotinine concentration (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02129387, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2022.