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Childhood trauma may rewire brain to crave nicotine

NCT ID NCT05665465

Knowledge-focused Sponsor: Duke University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at how difficult childhood experiences might change brain function and make people more likely to start smoking. Researchers will give a small dose of nicotine or a placebo to 150 nonsmoking young adults aged 18-21, then use brain scans and questionnaires to measure their reactions. The goal is to understand the link between childhood adversity and nicotine addiction risk.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Nicotine nasal spray (Nicotrol) and placebo nasal spray
What this could lead to
If successful, this study could help explain why some childhood experiences increase the risk of smoking, potentially guiding future prevention efforts.
What could go wrong
This is an early-phase study with only 150 participants, so findings may not apply broadly. It measures brain activity and subjective effects, not long-term smoking behavior.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2024

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 21 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

nicotine dependence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Adverse childhood experiences Nicotine dependence, cigarettes

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Duke University Medical Center

    RECRUITING

    Durham, North Carolina, 27710, United States

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