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OpenTrials
Completed

NCT Number: NCT04488744

Smoking by IV Pulsed Nicotine

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.

Completed

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Veterans Affairs Hospital

West Haven, Connecticut, 06516, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Nicotine 0.2mcg/kg/s and 1.0mcg/kg/s

Drug

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).

Other names: nicotine infusion

Primary outcomes

  1. Heart rate will be used to see the dose effect

    Time frame: During nicotine infusion max of ten minutes

    the dose-effect curves of nicotine dose and delivery rate in heart rate

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study title

Modeling Tobacco Smoking by IV Pulsed Nicotine in Smokers

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 28, 2020
Registry last updated
Jul 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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