Early Phase 1
N=23
Nicotine Delivery Rate and Its Abuse Potential: Impact of Menthol
Nicotine Dependence
Bottom Line
View on ClinicalTrials.gov: NCT03580525 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcome: Primary: Peak Changes on Items of the Drug Effects Questionnaire (DEQ) - Stimulatory Effects — 7.03; 37.48; 41.91; 28.22 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Nicotine saline infusion 0.00mcg/kg/s (Drug); Nicotine infusion 0.24mcg/kg/s (Drug); Nicotine infusion 0.096mcg/kg/s (Drug); Nicotine infusion 0.048 mcg/kg/s (Drug); Nicotine infusion 0.024mcg/kg/s (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Nov 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Peak Changes on Items of the Drug Effects Questionnaire (DEQ) - Stimulatory Effects |
7.03; 37.48; 41.91; 28.22; 22.12 | — |
| PRIMARY Peak Changes on Items of the Drug Effects Questionnaire (DEQ) - Pleasurable Effects |
8.83; 30.36; 36.73; 26; 21.19 | — |
Summary
A placebo-controlled study to enroll male and female tobacco smokers who will participate in five experimental sessions. subjects will be given an IV infusion of either saline or 1 mg nicotine at rapid, moderate or slow infusion rates (nicotine at 0.24,0.096, 0.048 and 0.024, mcg per kg body weight per sec).
Eligibility Criteria
Inclusion criteria
- Female and male smokers, aged 18 to 35 years, who have been smoking tobacco cigarettes for at least a year
- Smoke ≥ 5 and less than 20 cigarettes per day;
- Urine cotinine levels > 100 ng/mL consistent with nicotine intake of an active smoker (23)
- Not seeking treatment at the time of the study for nicotine dependence;
- In good health as verified by medical history, screening examination, and screening laboratory tests
- For women, not pregnant as determined by pregnancy screening, nor breast feeding, and using acceptable birth control methods.
Exclusion criteria
- History of major medical or psychiatric disorders that the physician investigator deems as contraindicated for the subject to be in the study
- Regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics)
- Current alcohol or substance dependence for any other recreational or prescription drugs other than nicotine
- Use of e-cigarettes more than 10 days in the past 30 days
- Urine drug screening indicating recent illicit drugs use (with the exception of marijuana).
Data sourced from ClinicalTrials.gov (NCT03580525). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.