NCT03134339 is a EARLY_PHASE1 clinical trial of Nicotine saline 0.00mcg/kg/s in Nicotine, sponsored by Yale University.

Who is sponsoring NCT03134339?

NCT03134339 is sponsored by Yale University.

What drugs are being tested in NCT03134339?

Interventions in NCT03134339: Nicotine saline 0.00mcg/kg/s, Nicotine 0.24 mcg/kg/s, Nicotine 0.048 mcg/kg/s, Nicotine 0.024 mcg/kg/s.

Is NCT03134339 still recruiting?

NCT03134339 is currently completed. Last updated 22 October 2018.

Last reviewed 2018-10-22 · How we verify

NCT03134339

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

The Effect of Nicotine Delivery Rate on Reinforcement

Completed EARLY_PHASE1 Last updated 22 October 2018

What this trial tests

EARLY_PHASE1 trial testing Nicotine saline 0.00mcg/kg/s in Nicotine in 18 participants. Completed in 29 January 2018.

Timeline

5 January 2017

Primary endpoint
29 January 2018

29 January 2018

Quick facts

Lead sponsor	Yale University
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	basic science
Enrollment	18
Start date	5 January 2017
Primary completion	29 January 2018
Estimated completion	29 January 2018
Sites	1 location across United States

Drugs / interventions tested

Nicotine saline 0.00mcg/kg/s — full drug profile →
Nicotine 0.24 mcg/kg/s — full drug profile →
Nicotine 0.048 mcg/kg/s — full drug profile →
Nicotine 0.024 mcg/kg/s — full drug profile →

Conditions studied

Nicotine — all drugs for Nicotine →

Sponsor

Yale University

Who can join

Adults 18 to 30, any sex, with Nicotine. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Differential effects of nicotine delivery rate on subjective drug effects, urges to smoke, heart rate and blood pressure in tobacco smokers.
Jensen KP, Valentine G, Gueorguieva R, Sofuoglu M. · · 2020 · cited 11× · PMID 31996940 · DOI 10.1007/s00213-020-05463-6

Verify or expand the search:

Other recruiting trials for Nicotine

Currently open trials in the same condition.

NCT07459712 — Pharmacokinetics and Pharmacodynamics of THS With LEVIA Compared to THS With TEREA and to Cigarettes · NA · active not recruiting
NCT07135648 — Nicotine Pharmacokinetics and Pharmacodynamics of Two Variants of VM 1.0 Compared to Cigarettes in Adult Current Smokers · NA · active not recruiting

Other Yale University trials

Trials by the same sponsor.

NCT06900998 — Pilot Study: Effects of Nimodipine on Alcohol Drinking · Phase 2 · not yet recruiting
NCT04910984 — Developing a Chatbot to Promote HIV Testing · NA · not yet recruiting
NCT07458087 — Accuracy of the Accuro 3S · NA · not yet recruiting
NCT07398404 — A Multiple Health Behavior Change (MHBC) Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Pa · Phase 1, PHASE2 · not yet recruiting
NCT07305324 — Improving Liver Fibrosis Diagnosis in Primary Care Using FibroX AI · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03134339 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Yale University
Last refreshed: 22 October 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03134339.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing