Nicotine Delivery Rate and Its Abuse Potential: Impact of Menthol

NCT ID: NCT03580525

Last Updated: 2024-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-14
• Study Completion Date: 2020-11-19

Brief 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).

Detailed Description

A placebo-controlled study that will enroll male and female tobacco smokers' menthol to participate in five experimental sessions. During the experimental session, 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). The infusion conditions for each experimental session will be determined in random order. Aim 1 is to establish a dose-effect curve for positive subjective effects (drug liking and good drug effects) and alleviation of smoking urges, as a function of nicotine delivery rate in menthol and non-menthol cigarette preferring smokers Aim 2 is to establish a dose-effect curve positive subjective effects and alleviation of smoking urges as a function of nicotine delivery rate. Aim 3 is to establish a dose-effect curve for nicotine's effect to alleviate symptoms of nicotine withdrawal in abstinent smokers as a function of nicotine delivery rate. Aim 4 is to establish a dose-effect curve for nicotine's acute cardiovascular health effects. Data from this project will help to establish benchmark values for nicotine's threshold effects that will guide policies on the nicotine yield of tobacco products. Presented is the time frame at which the peak change was strongest by treatment arm. The possible peak numbers could be 1, 3, 5, 7 and 10 minutes."

Conditions

Nicotine Dependence

Study Design

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

Study Groups

nicotine saline infusion 0.00mcg/kg/s

0.00 mcg/kg/s The day order will be randomized per day

Group Type: EXPERIMENTAL

Nicotine saline infusion 0.00mcg/kg/s

Intervention Type: DRUG

saline 0.00mcg/kg/s

nicotine infusion 0.24mcg/kg/s

0.24mcg/kg/s The day order will be randomized per day

Group Type: EXPERIMENTAL

Nicotine infusion 0.24mcg/kg/s

Intervention Type: DRUG

nicotine 0.24mcg/kg/s

nicotine infusion 0.096mcg/kg/s

0.096mcg/kg/s The day order will be randomized per day

Group Type: EXPERIMENTAL

Nicotine infusion 0.096mcg/kg/s

Intervention Type: DRUG

nicotine 0.096mcg/kg/s

nicotine infusion 0.048mcg/kg/s

0.048mcg/kg/s The day order will be randomized per day

Group Type: EXPERIMENTAL

Nicotine infusion 0.048 mcg/kg/s

Intervention Type: DRUG

nicotine 0.048mcg/kg/s

nicotine infusion 0.024mcg/kg/s

0.048mcg/kg/s The day order will be randomized per day

Group Type: EXPERIMENTAL

Nicotine infusion 0.024mcg/kg/s

Intervention Type: DRUG

nicotine 0.024mcg/kg/s

Interventions

Nicotine saline infusion 0.00mcg/kg/s

saline 0.00mcg/kg/s

Intervention Type: DRUG

Nicotine infusion 0.24mcg/kg/s

nicotine 0.24mcg/kg/s

Intervention Type: DRUG

Nicotine infusion 0.096mcg/kg/s

nicotine 0.096mcg/kg/s

Intervention Type: DRUG

Nicotine infusion 0.048 mcg/kg/s

nicotine 0.048mcg/kg/s

Intervention Type: DRUG

Nicotine infusion 0.024mcg/kg/s

nicotine 0.024mcg/kg/s

Intervention Type: DRUG

Other Intervention Names

nicotine infusion; nicotine infusion; nicotine infusion; nicotine infusion; 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 (23)
• 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
• 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

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

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

Professor of Psychiatry

Locations

Veterans Affairs Hospital

West Haven, Connecticut, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R03DA043004-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000023289

Identifier Type: -

Identifier Source: org_study_id