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Nicotine Delivery Rate and Its Abuse Potential: Impact of Menthol

NCT03580525 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-03-12

Study results available
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Summary

A placebo-controlled study to enroll male and female tobacco smokers who will participate in five experimental sessions. subjects will be given an IV infusion of either saline or 1 mg nicotine at rapid, moderate or slow infusion rates (nicotine at 0.24,0.096, 0.048 and 0.024, mcg per kg body weight per sec).

Conditions

  • Nicotine Dependence

Interventions

DRUG

Nicotine saline infusion 0.00mcg/kg/s

saline 0.00mcg/kg/s

DRUG

Nicotine infusion 0.24mcg/kg/s

nicotine 0.24mcg/kg/s

DRUG

Nicotine infusion 0.096mcg/kg/s

nicotine 0.096mcg/kg/s

DRUG

Nicotine infusion 0.048 mcg/kg/s

nicotine 0.048mcg/kg/s

DRUG

Nicotine infusion 0.024mcg/kg/s

nicotine 0.024mcg/kg/s

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Yale University

    lead OTHER

Principal Investigators

  • Mehmet Sofuoglu, M.D.,Ph.D. · Professor of Psychiatry

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2019-02-14
Primary Completion
2020-11-19
Completion
2020-11-19
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 NCT03580525 on ClinicalTrials.gov