← Back to Search

0.5mg nicotine for Adverse Childhood Experiences

Q: Are there any ongoing efforts to enroll patients in this current medical study?

Indeed, the information available on clinicaltrials.gov indicates that this specific clinical trial is currently in the process of actively recruiting eligible candidates. The initial posting of the study occurred on January 10th, 2024 and it was last updated on January 11th, 2024. In order to complete the trial successfully, a total of 150 participants will be sought from one location.

Q: What is the current number of participants being recruited for this medical study?

Indeed, according to the information available on clinicaltrials.gov, this ongoing clinical trial is actively seeking eligible participants. It was initially listed on January 10th, 2024 and most recently updated on January 11th, 2024. The study aims to enroll a total of 150 individuals at one designated site.

Q: Is the age bracket for participants in this medical study inclusive of individuals who are 80 years or older?

Per the eligibility criteria outlined in this clinical trial, individuals between 18 and 21 years of age are eligible for participation.

Q: Am I eligible to be a participant in this clinical trial?

This research is currently open to enrollment for 150 individuals aged between 18 and 21 who have experienced adverse childhood events. The essential criteria that applicants need to fulfill include being in good overall health, having never consumed a full cigarette or an equivalent amount of other nicotine/tobacco products, no exposure to tobacco within the past three years, an expired air CO level ≤ 3 ppm (parts per million), confirmation of non-<a href="https://www.withpower.com/clinical-trials/smoking">smoking</a> status from two independent sources, and a breath alcohol value of zero.

Phase < 1

Recruiting

Led By Maggie Sweitzer, PhD

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18-21 years of age

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, prior to intervention

Awards & highlights

Study Summary

This trial aims to understand how certain childhood experiences affect brain function and how the brain responds to nicotine exposure in young adults who do not smoke. Participants will be given either a small amount of nicotine or a

Who is the study for?

This trial is for healthy young adults aged 18-21 who have never smoked a full cigarette or used nicotine/tobacco products, with no tobacco exposure in the last three years. Participants must have an expired air CO level ≤ 3 ppm and their non-smoking status confirmed by two people.Check my eligibility

What is being tested?

The study tests how childhood experiences affect brain function and reaction to nicotine using a nasal spray containing either nicotine (0.5 mg) or placebo. Brain function is monitored through fMRI scans while participants perform tasks after exposure.See study design

What are the potential side effects?

Possible side effects from the nicotine nasal spray may include irritation of the nose and throat, sneezing, coughing, watery eyes, or headache. The placebo could cause mild irritation due to a tiny amount of pepper extract.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 21 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, prior to intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, prior to intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, prior to intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percent BOLD signal change in inferior frontal gyrus

Percent BOLD signal change in ventral striatum

Reinforcing effects of nicotine nasal spray

+2 more

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: 1mg nicotineExperimental Treatment1 Intervention

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

Group II: 0.5mg nicotineExperimental Treatment2 Interventions

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

Group III: PlaceboPlacebo Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor

2,364 Previous Clinical Trials

3,420,492 Total Patients Enrolled

National Institute on Drug Abuse (NIDA)NIH

2,470 Previous Clinical Trials

2,619,581 Total Patients Enrolled

Maggie Sweitzer, PhDPrincipal InvestigatorDuke University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any ongoing efforts to enroll patients in this current medical study?

"Indeed, the information available on clinicaltrials.gov indicates that this specific clinical trial is currently in the process of actively recruiting eligible candidates. The initial posting of the study occurred on January 10th, 2024 and it was last updated on January 11th, 2024. In order to complete the trial successfully, a total of 150 participants will be sought from one location."

Answered by AI

What is the current number of participants being recruited for this medical study?

"Indeed, according to the information available on clinicaltrials.gov, this ongoing clinical trial is actively seeking eligible participants. It was initially listed on January 10th, 2024 and most recently updated on January 11th, 2024. The study aims to enroll a total of 150 individuals at one designated site."

Answered by AI

Is the age bracket for participants in this medical study inclusive of individuals who are 80 years or older?

"Per the eligibility criteria outlined in this clinical trial, individuals between 18 and 21 years of age are eligible for participation."

Answered by AI

Am I eligible to be a participant in this clinical trial?

"This research is currently open to enrollment for 150 individuals aged between 18 and 21 who have experienced adverse childhood events. The essential criteria that applicants need to fulfill include being in good overall health, having never consumed a full cigarette or an equivalent amount of other nicotine/tobacco products, no exposure to tobacco within the past three years, an expired air CO level ≤ 3 ppm (parts per million), confirmation of non-smoking status from two independent sources, and a breath alcohol value of zero."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Neurobehavioral Mechanisms Linking Childhood Adversity to Increased Risk for Smoking

2024. "Neurobehavioral Mechanisms Linking Childhood Adversity to Increased Risk for Smoking". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05665465.