Smoking by IV Pulsed Nicotine

NCT04488744 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: MS059
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

To establish a dose-effect curve for nicotine's abuse potential as a function of nicotine dose and delivery rate. Pulsed IV nicotine administration will be used as it closely matches nicotine delivery by inhaled tobacco use.

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

• Heart rate will be used to see the dose effect

  the dose-effect curves of nicotine dose and delivery rate in heart rate

  During nicotine infusion max of ten minutes

Study Arms (5)

nicotine infusion 0.2mg

EXPERIMENTAL

nicotine infusion 0.2 mg nicotine delivered over 2.5 minutes (5 pulsed-nicotine deliveries) The day order will be randomized over 5 days.

Drug: Nicotine 0.2mcg/kg/s and 1.0mcg/kg/s

nicotine infusion 2.0mg

EXPERIMENTAL

0.2mg nicotine delivered over 10 min (20 pulsed-nicotine deliveries),

Drug: Nicotine 0.2mcg/kg/s and 1.0mcg/kg/s

nicotine infusion 1.0mg

EXPERIMENTAL

1.0 mg nicotine delivered over 2.5 minutes (5 pulsed-nicotine deliveries)

Drug: Nicotine 0.2mcg/kg/s and 1.0mcg/kg/s

nicotine infuison 1.0mg

EXPERIMENTAL

1.0 mg nicotine delivered over 10 min (20 pulsed-nicotine deliveries).

Drug: Nicotine 0.2mcg/kg/s and 1.0mcg/kg/s

Saline

PLACEBO COMPARATOR

saline delivered over 2minutes ,2.5minutes,10 minutes

Drug: Nicotine 0.2mcg/kg/s and 1.0mcg/kg/s

Interventions

Nicotine 0.2mcg/kg/s and 1.0mcg/kg/s DRUG

Nicotine infusion 0.2 mg nicotine delivered over 2.5 minutes (5 pulsed-nicotine deliveries), 0.2mg nicotine delivered over 10 min (20 pulsed-nicotine deliveries), 1.0 mg nicotine delivered over 2.5 minutes (5 pulsed-nicotine deliveries) and 1.0 mg nicotine delivered over 10 min (20 pulsed-nicotine deliveries).

Also known as: nicotine infusion

Saline; nicotine infuison 1.0mg; nicotine infusion 0.2mg; nicotine infusion 1.0mg; nicotine infusion 2.0mg

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female and male smokers, aged 18 to 35 years, who have been smoking tobacco cigarettes for at least a year
• smoke ≥ 5 and less than 20 cigarettes per day
• urine cotinine levels \> 100 ng/mL consistent with nicotine intake of an active smoker
• not seeking treatment at the time of the study for nicotine dependence
• in good health as verified by medical history, screening examination, and screening laboratory tests; and 6) for women, not pregnant as determined by pregnancy screening, nor breast feeding, and using acceptable birth control methods.

You may not qualify if:

• History of major medical or psychiatric disorders that the physician investigator deems as contraindicated for the subject to be in the study
• regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics)
• current alcohol or substance dependence for any other recreational or prescription drugs other than nicotine
• use of e-cigarettes more than 10 days in the past 30 days
• urine drug screening indicating recent illicit drugs use (with the exception of marijuana)

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Veterans Affairs Hospital

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Interventions

Nicotine

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Mehmet Sofuoglu, M.D.,Ph.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participant will not know nicotine dose or rate of infusion.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Model Details: placebo-controlled, mixed-design with nicotine dose as a between-subject and nicotine delivery rate as a within-subject factor.

Study Record Dates

• First Submitted: July 23, 2020
• First Posted: July 28, 2020
• Study Start: November 15, 2019
• Primary Completion: April 28, 2021
• Study Completion: May 31, 2021
• Last Updated: July 20, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)