IV Pulsed-Nicotine as a Model of Smoking: The Effects of Dose and Delivery Rate

April 12, 2024 updated by: Mehmet Sofuoglu, Yale University
This project will examine the impact of the nicotine dose and delivery rate on nicotine's abuse potential, versus its potentially beneficial effects on smoking urges and withdrawal. Will use pulsed IV nicotine administration which closely matches nicotine delivery by inhaled tobacco use.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Seventy smokers will be randomized to nicotine doses of either 0.2 or 1 mg per 70 kg body weight. Across 5 test sessions, within each dose group, participants will be randomly assigned to a sequence of 5 treatment conditions: placebo (saline) and 4 different delivery rates of nicotine. In each session, participants will receive either nicotine- or saline-pulsed infusions that will be delivered every 30 seconds for a total of 10 pulsed infusions. While receiving the pulsed infusions, participants will inhale a tobacco-flavored EC without nicotine, which will allow for a closer matching of the sensory aspects of inhaled tobacco use. There are four pulse duration conditions for the nicotine sessions: 2-, 4-, 6- and 8-second pulses. For those assigned to 1.0 mg/70kg nicotine dose, the pulse duration conditions correspond to nicotine delivery rates of 50, 25, 16.6, and 12.5 mcg nicotine/second. For those assigned to 0.2 mg/70 kg dose, the corresponding delivery rates will be 10, 5, 3.3 and 2.5 mcg nicotine/second. Participants in both nicotine dose groups will each have one placebo test session wherein they will receive 10 pulsed-saline infusions.

Study Type

Interventional

Enrollment (Estimated)

70

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 Contact

Study Locations

  • United States
    • Connecticut
      • West Haven, Connecticut, United States, 06516
        • Recruiting
        • VA Healthcare System
        • Contact:

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

21 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Female and male, aged 21 to 55 years;
  • past year daily cigarette use, verified by urine cotinine levels above 100 ng/ml -lifetime history of e-cigarette use; in good health as verified by medical history -screening examination, and screening laboratory tests
  • women, -using acceptable birth control methods.

Exclusion Criteria:

  • History of major medical or psychiatric disorders that the physician investigator deems as contraindicated for the participant to be in the study
  • risk factors for EVALI (E-cigarette or Vaping Product Use-Associated Lung Injury) including history of lung diseases (e.g., asthma or COPD), vaping THC or CBD
  • regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics)
  • current alcohol or substance use disorder for any other recreational or prescription drugs other than nicotine
  • for women, pregnant as determined by pregnancy screening, or breast feeding
  • seeking (or undergoing) treatment for tobacco dependence or smoking; reported aversion to e-cigarettes, or tobacco flavored e-liquid.

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: delivery rate for nicotine dose 1mg/70kg
delivery rate 50,35, 16.6 and 12.5 ug per second
Drug: low dose Nicotine
IV nicotine infused over different delivery rates
Other Names:
  • IV nicotine 1mg/70kg
Active Comparator: Delivery rate for nicotine dose 0.2mg/70kg
delivery rate 10,5, 3.3 and 2.5
Drug: high dose Nicotine
IV Nicotine infused over different delivery rates
Other Names:
  • IV Nicotine 0.2/70kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Drug Effects Questionnaire mean score
Time Frame: up to five years
The DEQ measures Good Drug Effect and consists of 11 questions with total score range from 0-100. Higher scores indicate more positive effects.
up to five years

Collaborators and Investigators

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

Sponsor

Yale University

Investigators

  • Principal Investigator: Mehmet Sofuoglu, M.D.,Ph.D, 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)

September 9, 2022

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

November 19, 2021

First Submitted That Met QC Criteria

December 14, 2021

First Posted (Actual)

January 4, 2022

Study Record Updates

Last Update Posted (Estimated)

April 15, 2024

Last Update Submitted That Met QC Criteria

April 12, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HIC 2000032210

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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