RECRUITING

Neurobehavioral Mechanisms Linking Childhood Adversity to Increased Risk for Smoking

Conditions

Adverse Childhood Experiences Nicotine Dependence, Cigarettes

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to evaluate how certain childhood experiences influences brain function and responses to nicotine exposure in a group of nonsmoking young adults. The investigators assess responses to nicotine exposure by giving participants a small amount of nicotine or placebo, and then asking them to answer questionnaires. The investigational drugs used in this study are a nicotine nasal spray (i.e., Nicotrol) and/or a nasal spray placebo (made of common kitchen ingredients, including a very tiny amount of pepper extract also called capsaicin). The investigators assess brain function through function magnetic resonance imaging (fMRI), which is a noninvasive procedure that uses a magnetic field to take pictures of your brain while you are performing certain tasks. This study will help us to learn more about why some childhood experiences (adverse childhood experiences, or ACEs) contribute to increased risk for smoking and other substance use.

Official Title

Neurobehavioral Mechanisms Linking Childhood Adversity to Increased Risk for Smoking

Quick Facts

Study Start:2024-01-19

Study Completion:2027-03-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05665465

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
1. generally healthy 2. 18-21 years of age 3. never smoked a full cigarette or used an equivalent amount of other nicotine or tobacco products 4. no tobacco exposure in the past 3 years 5. expired air CO level ≤ 3 ppm 6. corroboration of non-smoking status from 2 collateral reporters 7. breath alcohol value = 0.000	1. use of illegal drugs as measured by urine drug screen 2. reported history of illicit drug use \> 10 times lifetime 3. lifetime history of alcohol use disorder 4. binge drinking \> 5 times per month over the past 3 months 5. history of serious mental illness including bipolar or psychotic disorders 6. significant medical or unstable psychiatric disorders 7. systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg 8. heart rate ≥ 100 bpm 9. use of psychoactive medications (e.g., antidepressants, opioid analgesics, etc.) in the past 6 months 10. presence of conditions that would make fMRI unsafe (e.g., pacemaker) 11. brain abnormality (including but not limited to stroke, brain tumor, and seizure disorder) 12. history of serious traumatic brain injury 13. claustrophobia 14. lack of firm resolve to refrain from cigarette, e-cigarette or other tobacco use in the coming year 15. pregnant, trying to become pregnant, or breastfeeding 16. inability to understand written and/or spoken English language 17. inability to attend all experimental sessions

Inclusion Criteria

Exclusion Criteria

1. generally healthy
2. 18-21 years of age
3. never smoked a full cigarette or used an equivalent amount of other nicotine or tobacco products
4. no tobacco exposure in the past 3 years
5. expired air CO level ≤ 3 ppm
6. corroboration of non-smoking status from 2 collateral reporters
7. breath alcohol value = 0.000

1. use of illegal drugs as measured by urine drug screen
2. reported history of illicit drug use \> 10 times lifetime
3. lifetime history of alcohol use disorder
4. binge drinking \> 5 times per month over the past 3 months
5. history of serious mental illness including bipolar or psychotic disorders
6. significant medical or unstable psychiatric disorders
7. systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg
8. heart rate ≥ 100 bpm
9. use of psychoactive medications (e.g., antidepressants, opioid analgesics, etc.) in the past 6 months
10. presence of conditions that would make fMRI unsafe (e.g., pacemaker)
11. brain abnormality (including but not limited to stroke, brain tumor, and seizure disorder)
12. history of serious traumatic brain injury
13. claustrophobia
14. lack of firm resolve to refrain from cigarette, e-cigarette or other tobacco use in the coming year
15. pregnant, trying to become pregnant, or breastfeeding
16. inability to understand written and/or spoken English language
17. inability to attend all experimental sessions

Contacts and Locations

Study Contact

Maggie Sweitzer, PhD

CONTACT

919-668-0094

maggie.sweitzer@duke.edu

Principal Investigator

Maggie Sweitzer, PhD

PRINCIPAL_INVESTIGATOR

Duke University

Study Locations (Sites)

Duke University Medical Center

Durham, North Carolina, 27710

United States

Collaborators and Investigators

Sponsor: Duke University

Maggie Sweitzer, PhD, PRINCIPAL_INVESTIGATOR, Duke University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-19

Study Completion Date2027-03-31

Study Record Updates

Study Start Date2024-01-19

Study Completion Date2027-03-31

Terms related to this study

Additional Relevant MeSH Terms

Adverse Childhood Experiences
Nicotine Dependence, Cigarettes