Smoking by IV Pulsed Nicotine

July 13, 2021 updated by: Mehmet Sofuoglu, Yale University

Modeling Tobacco Smoking by IV Pulsed Nicotine in Smokers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

13

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • West Haven, Connecticut, United States, 06516
        • Veterans Affairs Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: nicotine infusion 0.2mg

nicotine infusion

0.2 mg nicotine delivered over 2.5 minutes (5 pulsed-nicotine deliveries) The day order will be randomized over 5 days.
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).
Other Names:
  • nicotine infusion
EXPERIMENTAL: nicotine infusion 2.0mg
0.2mg nicotine delivered over 10 min (20 pulsed-nicotine deliveries),
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).
Other Names:
  • nicotine infusion
EXPERIMENTAL: nicotine infusion 1.0mg
1.0 mg nicotine delivered over 2.5 minutes (5 pulsed-nicotine deliveries)
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).
Other Names:
  • nicotine infusion
EXPERIMENTAL: nicotine infuison 1.0mg
1.0 mg nicotine delivered over 10 min (20 pulsed-nicotine deliveries).
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).
Other Names:
  • nicotine infusion
PLACEBO_COMPARATOR: Saline
saline delivered over 2minutes ,2.5minutes,10 minutes
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).
Other Names:
  • nicotine infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
During nicotine infusion max of ten minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 15, 2019

Primary Completion (ACTUAL)

April 28, 2021

Study Completion (ACTUAL)

May 31, 2021

Study Registration Dates

First Submitted

July 23, 2020

First Submitted That Met QC Criteria

July 23, 2020

First Posted (ACTUAL)

July 28, 2020

Study Record Updates

Last Update Posted (ACTUAL)

July 20, 2021

Last Update Submitted That Met QC Criteria

July 13, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS059

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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