Effects of IV Nicotine Dose and Delivery Rate on Smoking Behavior
IV Pulsed-Nicotine as a Model of Smoking: The Effects of Dose and Delivery Rate
This study is testing how different amounts and speeds of nicotine delivered through an IV can help smokers manage their cravings and withdrawal symptoms.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 21 Years to 55 Years |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 1 site (West Haven, Connecticut) |
| Trial ID | NCT05176418 on ClinicalTrials.gov |
What this trial studies
This project investigates how different doses and delivery rates of intravenous nicotine affect its potential for abuse and its ability to alleviate smoking urges and withdrawal symptoms. Seventy smokers will be randomized into two nicotine dose groups and will participate in five test sessions where they receive either nicotine or saline infusions. The study will utilize a tobacco-flavored e-cigarette to simulate the sensory experience of smoking while administering pulsed nicotine infusions at varying rates. The goal is to better understand the relationship between nicotine delivery and its effects on smoking behavior.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 21 to 55 who are daily smokers with a history of e-cigarette use.
Not a fit: Patients with major medical or psychiatric disorders, or those with a history of lung diseases, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatments for nicotine dependence and smoking cessation.
How similar studies have performed: Previous studies have explored nicotine delivery methods, but this specific approach using pulsed IV administration is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female and male, aged 21 to 55 years; * past year daily cigarette use, verified by urine cotinine levels above 100 ng/ml -lifetime history of e-cigarette use; in good health as verified by medical history -screening examination, and screening laboratory tests * women, -using acceptable birth control methods. Exclusion Criteria: * History of major medical or psychiatric disorders that the physician investigator deems as contraindicated for the participant to be in the study * risk factors for EVALI (E-cigarette or Vaping Product Use-Associated Lung Injury) including history of lung diseases (e.g., asthma or COPD), vaping THC or CBD * regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics) * current alcohol or substance use disorder for any other recreational or prescription drugs other than nicotine * for women, pregnant as determined by pregnancy screening, or breast feeding * seeking (or undergoing) treatment for tobacco dependence or smoking; reported aversion to e-cigarettes, or tobacco flavored e-liquid.
Where this trial is running
West Haven, Connecticut
- VA Healthcare System — West Haven, Connecticut, United States (Recruiting)
Study contacts
- Principal investigator: Mehmet Sofuoglu, M.D.,Ph.D — Yale University
- Study coordinator: Mehmet Sofuoglu,, M.D.,Ph.D.
- Email: mehmet.sofuoglu@yale.edu
- Phone: 203-932-5711
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.