Neurobehavioral Mechanisms Linking Childhood Adversity to Increased Risk for Smoking
This study is looking for young adults (ages 18-21) who have never smoked to understand how childhood experiences might affect brain function and responses to nicotine. Researchers will give participants either nicotine nasal spray (Nicotrol) or a placebo nasal spray and ask about their reactions. They will also use fMRI (functional magnetic resonance imaging), a non-invasive brain scan, to see how your brain works during certain tasks. The goal is to learn why adverse childhood experiences (ACEs) might increase the risk of smoking later in life. The study aims to enroll 150 participants, but its current status is unclear.
- Study design
- This interventional study plans to enroll 150 participants, who will receive either nicotine nasal spray or a placebo nasal spray.
- What's involved
- You would attend 7 visits, including an MRI scan and several sessions where you'll receive nasal spray and answer questionnaires.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoints measure subjective effects and reinforcing effects of nicotine nasal spray during sessions lasting approximately 3-4 hours.
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Neurobehavioral Mechanisms Linking Childhood Adversity to Increased Risk for Smoking
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Maggie Sweitzer, PhD · PRINCIPAL_INVESTIGATOR · Duke University
Who to contact
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What this trial measures
- Subjective effects of nicotine nasal spray as measured by the Nicotine Effects Questionnaireduring fixed dose session, approximately 3 hrs
subjective effects will be measured by the Nicotine Effects Questionnaire at the end of each fixed dose session. This scale measure positive reactions, negative reactions, and dizziness on a scale from 0-3 where 0 is none and 3 is intense.
- Subjective effects of nicotine nasal spray as measured by a visual analog scaleduring fixed dose session, approximately 3 hrs
subjective effects will be measured on a visual analog scale at the end of each fixed dose session. Ratings will be provided on a scale of 0=not at all to 100=an awful lot.
- Reinforcing effects of nicotine nasal sprayduring choice session, approximately 4 hrs
reinforcing effects will be measured by the number of choices for nicotine spray (range 0-8) during the forced choice session.
- Percent BOLD signal change in ventral striatumbaseline, prior to intervention
Percent blood oxygen level-dependent (BOLD) signal change during anticipation of monetary gain versus baseline during the Reward Guessing Task will be extracted from the bilateral ventral striatum
- Percent BOLD signal change in inferior frontal gyrusbaseline, prior to intervention
Percent BOLD signal change during "rare go" versus "no-go" trials during the Go/No-Go Task will be extracted from the right inferior frontal gyrus