Smoking by IV Pulsed Nicotine

Smoking Cessation Clinical Trial

Official title:

Modeling Tobacco Smoking by IV Pulsed Nicotine in Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04488744
• Other study ID #: MS059
• Status: Completed
• Phase: Early Phase 1
• Start date: November 15, 2019
• Est. completion date: May 31, 2021

Study information

• Verified date: July 2021
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: May 31, 2021
• Est. primary completion date: April 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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)

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Drug:
• 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), 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).

Locations

Country	Name	City	State
United States	Veterans Affairs Hospital	West Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate will be used to see the dose effect	the dose-effect curves of nicotine dose and delivery rate in heart rate	During nicotine infusion max of ten minutes