Clinical trial NCT04488744: Smoking by IV Pulsed Nicotine
Official title: Modeling Tobacco Smoking by IV Pulsed Nicotine in Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Smoking Cessation
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2020-07-28
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: placebo-controlled, mixed-design with nicotine dose as a between-subject and nicotine delivery rate as a within-subject factor.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To establish a dose-effect curve for nicotine's abuse potential as a function of nicotine dose and delivery rate. Pulsed IV nicotine administration will be used as it closely matches nicotine delivery by inhaled tobacco use.

Detailed description: Both sub-studies will enroll male and female tobacco cigarette smokers. This study will examine the feasibility of the proposed study parameters in a total of 10 completers. In a crossover design, participants will be tested under 5 conditions: 0.2 mg nicotine delivered over 2.5 minutes (5 pulsed-nicotine deliveries), 0.2mg nicotine delivered over 10 min (20 pulsed-nicotine deliveries), 1.0 mg nicotine delivered over 2.5 minutes (5 pulsed-nicotine deliveries) and 1.0 mg nicotine delivered over 10 min (20 pulsed-nicotine deliveries). The main outcome measures will be self-report drug effects and urges to smoke cigarettes.

The investigators hypothesize that the abuse potential and alleviation of smoking urges are produced by nicotine as a function of nicotine dose and delivery rate.

This study is complete with 13 enrolled and 10 completers

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
* 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; and 6) 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)

Primary outcomes:
measure: Heart rate will be used to see the dose effect
timeFrame: During nicotine infusion max of ten minutes
Secondary outcomes:
Other outcomes:
Locations:
city: West Haven
country: United States
facility: Veterans Affairs Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Mehmet Sofuoglu, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: