Smoking by IV Pulsed Nicotine

Early Phase 1

Completed

• Conditions: Smoking Cessation
• Interventions: Drug: Nicotine 0.2mcg/kg/s and 1.0mcg/kg/s

• Registration Number: NCT04488744
• Lead Sponsor: Yale University

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

Study Timeline

• Study Start: 2019-11-15
• Study First Submitted: 2020-07-23
• Study First Submitted QC: 2020-07-23
• Study First Posted: 2020-07-28
• Primary Completion: 2021-04-28
• Study Completion: 2021-05-31
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-13
• Last Update Posted: 2021-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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.

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
nicotine infusion 2.0mg	Nicotine 0.2mcg/kg/s and 1.0mcg/kg/s	0.2mg nicotine delivered over 10 min (20 pulsed-nicotine deliveries),
Saline	Nicotine 0.2mcg/kg/s and 1.0mcg/kg/s	saline delivered over 2minutes ,2.5minutes,10 minutes
nicotine infusion 0.2mg	Nicotine 0.2mcg/kg/s and 1.0mcg/kg/s	nicotine infusion 0.2 mg nicotine delivered over 2.5 minutes (5 pulsed-nicotine deliveries) The day order will be randomized over 5 days.
nicotine infusion 1.0mg	Nicotine 0.2mcg/kg/s and 1.0mcg/kg/s	1.0 mg nicotine delivered over 2.5 minutes (5 pulsed-nicotine deliveries)
nicotine infuison 1.0mg	Nicotine 0.2mcg/kg/s and 1.0mcg/kg/s	1.0 mg nicotine delivered over 10 min (20 pulsed-nicotine deliveries).

Primary Outcome Measures

Name	Time	Method
Heart rate will be used to see the dose effect	During nicotine infusion max of ten minutes	the dose-effect curves of nicotine dose and delivery rate in heart rate

Trial Locations

Locations (1)

Veterans Affairs Hospital; 🇺🇸 West Haven, Connecticut, United States