Recruiting
Early Phase 1

Observational Study

Sponsor:

Duke University

Code:

NCT05665465

Conditions

Adverse Childhood Experiences

Nicotine Dependence, Cigarettes

Eligibility Criteria

Sex: All

Age: 18 - 21

Healthy Volunteers: Accepted

Interventions

Nicotine nasal spray 0.5 mg

Placebo

Study Details

Brief summary:

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.

Conditions

Adverse Childhood Experiences

Nicotine Dependence, Cigarettes

Study ID

NCT05665465

Start date

Jan 19, 2024

Status verified date

Apr, 2026

Completion date

May 31, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 21

Healthy Volunteers: Accepted

Inclusion 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

Exclusion Criteria:

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

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

Participants will be administered 2 nasal sprays with a combined nicotine content of 0mg nicotine, 0.1mL

experimental: 0.5mg nicotine

Participants will be administered 2 nasal sprays with a combined nicotine content of 0.5 mg nicotine, 0.1mL

experimental: 1mg nicotine

Participants will be administered 2 nasal sprays with a combined nicotine content of 1.0 mg nicotine, 0.1mL

Interventions

Nicotine nasal spray 0.5 mg

Participants will be administered nicotine nasal spray and provide subjective reactions

Placebo

Participants will be administered placebo nasal spray and provide subjective reactions

Primary outcome measure

  • Subjective effects of nicotine nasal spray as measured by the Nicotine Effects Questionnaire [ Time Frame: during fixed dose session, approximately 3 hrs ]
  • Subjective effects of nicotine nasal spray as measured by a visual analog scale [ Time Frame: during fixed dose session, approximately 3 hrs ]
  • Reinforcing effects of nicotine nasal spray [ Time Frame: during choice session, approximately 4 hrs ]
  • Percent BOLD signal change in ventral striatum [ Time Frame: baseline, prior to intervention ]
  • Percent BOLD signal change in inferior frontal gyrus [ Time Frame: baseline, prior to intervention ]

Central Contacts and Locations

Central contacts

Locations

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710

Contacts

More Information

Sponsor

Duke University

Last update posted

Apr 2, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-04-02.