Neurobehavioral Mechanisms Linking Childhood Adversity to Increased Risk for Smoking
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-21
SponsorDuke University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
generally healthy
18-21 years of age
never smoked a full cigarette or used an equivalent amount of other nicotine or tobacco products
no tobacco exposure in the past 3 years
Disqualifiers
use of illegal drugs as measured by urine drug screen
reported history of illicit drug use > 10 times lifetime
lifetime history of alcohol use disorder
binge drinking > 5 times per month over the past 3 months
Trial design
Design model
Crossover
Treatments tested in this trial
Nicotine nasal spray 0.5 mg
DrugParticipants will be administered nicotine nasal spray and provide subjective reactions
Placebo
DrugParticipants will be administered placebo nasal spray and provide subjective reactions
Treatment groups
150 Participants
are divided into 3 treatment groupsGroup A: PlaceboPlacebo comparator 1 intervention
Group B: 0.5mg nicotineExperimental treatment 2 interventions
Group C: 1mg nicotineExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Subjective effects of nicotine nasal spray as measured by the Nicotine Effects Questionnaire
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.
Time frame
during fixed dose session, approximately 3 hrs2
Subjective effects of nicotine nasal spray as measured by a visual analog scale
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.
Time frame
during fixed dose session, approximately 3 hrs3
Reinforcing effects of nicotine nasal spray
reinforcing effects will be measured by the number of choices for nicotine spray (range 0-8) during the forced choice session.
Time frame
during choice session, approximately 4 hrs4
Percent BOLD signal change in ventral striatum
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
Time frame
baseline, prior to interventionSponsors and contacts
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Duke University
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov