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The Effect of Nicotine Delivery Rate on Reinforcement

NCT03134339 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2018-10-22

No results posted yet for this study

Summary

The dose-effect curve to estimate a threshold delivery rate for reinforcement. The project addresses the FDA Center for Tobacco Products (CTP) interest #1: Nicotine dependence threshold among youth and adults and impact of nicotine reduction on tobacco product use behavior (e.g., topography, compensation, switching, multiple use, initiation, cessation and relapse). IV nicotine, in contrast to ECs, can deliver precise, reproducible dosing, which is necessary for accurately assessing dose-response and threshold effects. The estimated threshold for reinforcement will establish a benchmark for evaluating the addictive potential of ECs and other inhaled nicotine products.

Conditions

  • Nicotine

Interventions

DRUG

Nicotine saline 0.00mcg/kg/s

saline 0.00mcg/kg/s

DRUG

Nicotine 0.24 mcg/kg/s

nicotine 0.24 mcg/kg/s

DRUG

Nicotine 0.048 mcg/kg/s

nicotine 0.048 mcg/kg/s

DRUG

Nicotine 0.024 mcg/kg/s

nicotine 0.024 mcg/kg/s

Sponsors & Collaborators

  • Yale University

    lead OTHER

Principal Investigators

  • Kevin Jensen, Ph.D. · Yale University

  • Mehmet Sofuoglu, M.D.,Ph.D. · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-05
Primary Completion
2018-01-29
Completion
2018-01-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03134339 on ClinicalTrials.gov