Smoking by IV Pulsed Nicotine

NCT ID: NCT04488744

Last Updated: 2021-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-15
• Study Completion Date: 2021-05-31

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.

Detailed Description

Both sub-studies will enroll male and female tobacco cigarette smokers. This study will examine the feasibility of the proposed study parameters in a total of 10 completers. In a crossover design, participants will be tested under 5 conditions: 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). The main outcome measures will be self-report drug effects and urges to smoke cigarettes.

The investigators hypothesize that the abuse potential and alleviation of smoking urges are produced by nicotine as a function of nicotine dose and delivery rate.

This study is complete with 13 enrolled and 10 completers

Conditions

Smoking Cessation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

nicotine infusion 0.2mg

nicotine infusion

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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).

nicotine infusion 2.0mg

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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).

nicotine infusion 1.0mg

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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).

nicotine infuison 1.0mg

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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).

Saline

saline delivered over 2minutes ,2.5minutes,10 minutes

Group Type: PLACEBO_COMPARATOR

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

Intervention Type: 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).

Interventions

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

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).

Intervention Type: DRUG

Other Intervention Names

nicotine infusion

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Mehmet Sofuoglu

Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mehmet Sofuoglu, M.D.,Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Veterans Affairs Hospital

West Haven, Connecticut, United States

Countries

United States

Other Identifiers

MS059

Identifier Type: -

Identifier Source: org_study_id