NCT03580525

Nicotine Delivery Rate and Its Abuse Potential: Impact of Menthol

Completed EARLY_PHASE1 Results posted Last updated 12 March 2024

What this trial tests

EARLY_PHASE1 trial testing Nicotine saline infusion 0.00mcg/kg/s in Nicotine Dependence in 24 participants. Completed in 19 November 2020.

Timeline

14 February 2019

Primary endpoint
19 November 2020

19 November 2020

Quick facts

Lead sponsor	Yale University
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	health services research
Enrollment	24
Start date	14 February 2019
Primary completion	19 November 2020
Estimated completion	19 November 2020
Sites	1 location across United States

Drugs / interventions tested

• Nicotine saline infusion 0.00mcg/kg/s — full drug profile →
• Nicotine infusion 0.24mcg/kg/s — full drug profile →
• Nicotine infusion 0.096mcg/kg/s — full drug profile →
• Nicotine infusion 0.048 mcg/kg/s — full drug profile →
• Nicotine infusion 0.024mcg/kg/s — full drug profile →

Conditions studied

• Nicotine Dependence — all drugs for Nicotine Dependence →

Sponsor

Yale University

Who can join

Adults 18 to 35, any sex, with Nicotine Dependence. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Peak Changes on Items of the Drug Effects Questionnaire (DEQ) - Stimulatory Effects Primary · up to 10 minutes

The peak change in the intensity of subjective effects as measured by the DEQ: Drug stimulatory effects questionnaire; Eleven questions with a minimum score of 0 to a maximum score of 100. Presented is the DEQ score at which the peak change was strongest by treatment arm. Each session took approximately 60 minutes, however the measures were only collected up to 10 minutes post infusion. This correction to the outcome time frame was made when the results were entered. Data were collected at 1, 3, 5, 7 and 10 minute intervals. The outcome measure title DEQ Stimulatory Effects measure was also up

nicotine saline infusion 0.00mcg/kg/s

Group	Value	95% CI
Randomized Participants	7.03	± 5.34

nicotine infusion 0.24mcg/kg/s

Group	Value	95% CI
Randomized Participants	37.48	± 5.14

nicotine infusion 0.096mcg/kg/s

Group	Value	95% CI
Randomized Participants	41.91	± 5.15

nicotine infusion 0.048mcg/kg/s

Group	Value	95% CI
Randomized Participants	28.22	± 5.22

nicotine infusion 0.024mcg/kg/s

Group	Value	95% CI
Randomized Participants	22.12	± 5.05

Peak Changes on Items of the Drug Effects Questionnaire (DEQ) - Pleasurable Effects Primary · up to 10 minutes post infusion

The peak change in the intensity of subjective effects as measured by the DEQ: Drug pleasurable effects questionnaire; Eleven questions with a minimum score of 0 to a maximum score of 100. Presented is the DEQ score at which the peak change was strongest by treatment arm. Each session took approximately 60 minutes, however the measures were only collected up to 10 minutes post infusion. This correction to the outcome time frame was made when the results were entered. Data were collected at 1, 3, 5, 7 and 10 minute intervals. The outcome measure title DEQ Stimulatory Effects measure was also up

nicotine saline infusion 0.00mcg/kg/s

Group	Value	95% CI
Randomized Participants	8.83	± 5.09

nicotine infusion 0.24mcg/kg/s

Group	Value	95% CI
Randomized Participants	30.36	± 4.96

nicotine infusion 0.096mcg/kg/s

Group	Value	95% CI
Randomized Participants	36.73	± 4.97

nicotine infusion 0.048mcg/kg/s

Group	Value	95% CI
Randomized Participants	26	± 5

nicotine infusion 0.024mcg/kg/s

Group	Value	95% CI
Randomized Participants	21.19	± 4.89

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.