Overview

Nicotine Differences in Smokers

Status:
Not yet recruiting
Trial end date:
2023-03-01
Target enrollment:
0
Participant gender:
All
Summary
The primary aim of this project is to determine the threshold dose of nicotine, which the smokers will be able to differentiate from placebo (saline). Will use IV pulsed-nicotine infusion that closely matches nicotine delivery by inhaled tobacco use (i.e., tobacco cigarette or electronic cigarette), allowing precise and reproducible nicotine delivery. Four nicotine doses (0.1, 0.05, 0.025, and 0.0125 mg nicotine/pulse) which are within the range of nicotine doses that are delivered by cigarettes with very low to regular nicotine content. These doses will be delivered as a cluster of 4 pulsed-nicotine infusions of 2 sec duration with a 28 sec interval between each dose.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Yale University
Treatments:
Nicotine
Criteria
Inclusion criteria:

- Female and male smokers, aged 18 to 65 years veterans and non-veterans who have been
smoking tobacco cigarettes for at least a year

- smoke ≥ 5 cigs/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

- 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).