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Nicotine Dosing for Nicotine Addiction

Phase < 1
Recruiting
Led By Mehmet Sofuoglu, M.D.,Ph.D
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female and male, aged 21 to 55 years
Be between 18 and 65 years old
Must not have
For women, pregnant as determined by pregnancy screening, or breastfeeding
Risk factors for EVALI including history of lung diseases (e.g., asthma or COPD), vaping THC or CBD
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to five years
Awards & highlights
No Placebo-Only Group

Summary

This trial will study the effects of different levels of nicotine on smokers' urges and withdrawal symptoms.

Who is the study for?
This trial is for adults aged 21 to 55 who smoke cigarettes daily, as confirmed by urine tests. Participants must be in good health and not seeking treatment for tobacco dependence. Women should use birth control methods. People with major medical or psychiatric issues, substance abuse other than nicotine, or risks for vaping-related lung injury cannot join.
What is being tested?
The study investigates how different doses and delivery rates of IV pulsed-nicotine affect its potential for abuse versus its benefits on reducing smoking urges and withdrawal symptoms. It mimics the nicotine hit from smoking tobacco.
What are the potential side effects?
While specific side effects are not listed here, generally nicotine can cause dizziness, nausea, increased heart rate or blood pressure changes among others. The trial will monitor these effects closely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 21 and 55 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant or breastfeeding.
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I have lung conditions like asthma or COPD, or I vape THC or CBD.
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I regularly take medication for mental health issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to five years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to five years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Drug Effects Questionnaire mean score

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: delivery rate for nicotine dose 1mg/70kgActive Control1 Intervention
delivery rate 50,35, 16.6 and 12.5 ug per second
Group II: Delivery rate for nicotine dose 0.2mg/70kgActive Control1 Intervention
delivery rate 10,5, 3.3 and 2.5

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,930 Previous Clinical Trials
3,033,404 Total Patients Enrolled
1 Trials studying Smoking Addiction
36 Patients Enrolled for Smoking Addiction
Mehmet Sofuoglu, M.D.,Ph.DPrincipal InvestigatorYale University

Media Library

Nicotine (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05176418 — Phase < 1
Smoking Addiction Research Study Groups: delivery rate for nicotine dose 1mg/70kg, Delivery rate for nicotine dose 0.2mg/70kg
Smoking Addiction Clinical Trial 2023: Nicotine Highlights & Side Effects. Trial Name: NCT05176418 — Phase < 1
Nicotine (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05176418 — Phase < 1
~14 spots leftby Aug 2025
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