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New treatment option for Adverse Childhood Experiences
Official title Neurobehavioral Mechanisms Linking Childhood Adversity to Increased Risk for Smoking
ClinicalTrials.gov ID: NCT05665465
What this study is testing
What is Nicotine nasal spray 0.5 mg?
Nicotine nasal spray 0.5 mg is an investigational medicine, being studied as a potential treatment for adverse childhood experiences.
Also referred to as Nicotrol.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 21. Healthy volunteers may be eligible.
You may be able to join if
- 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
- expired air CO level ≤ 3 ppm
You likely can't join if
- 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
- history of serious mental illness including bipolar or psychotic disorders
- significant medical or unstable psychiatric disorders
See the full eligibility criteria
- 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
- expired air CO level ≤ 3 ppm
- corroboration of non-smoking status from 2 collateral reporters
- breath alcohol value = 0.000
- 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
- history of serious mental illness including bipolar or psychotic disorders
- significant medical or unstable psychiatric disorders
- systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg
- heart rate ≥ 100 bpm
- use of psychoactive medications (e.g., antidepressants, opioid analgesics, etc.) in the past 6 months
- presence of conditions that would make fMRI unsafe (e.g., pacemaker)
- brain abnormality (including but not limited to stroke, brain tumor, and seizure disorder)
- history of serious traumatic brain injury
- claustrophobia
- lack of firm resolve to refrain from cigarette, e-cigarette or other tobacco use in the coming year
- pregnant, trying to become pregnant, or breastfeeding
- inability to understand written and/or spoken English language
- inability to attend all experimental sessions
The study team makes the final eligibility decision.
Where it's taking place
- Durham, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 21 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Durham, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.