Nicotine Delivery Rate and Its Abuse Potential: Impact of Menthol

NCT03580525 | Completed Early Phase 1 Results DMC FDA Drug

• 2 other identifiers: 2000023289R03DA043004-01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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).

Conditions

Nicotine Dependence

Outcome Measures

Primary Outcomes (2)

• Peak Changes on Items of the Drug Effects Questionnaire (DEQ) - Stimulatory Effects

  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 updated.

  up to 10 minutes

• Peak Changes on Items of the Drug Effects Questionnaire (DEQ) - Pleasurable Effects

  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 updated.

  up to 10 minutes post infusion

Study Arms (5)

nicotine saline infusion 0.00mcg/kg/s

EXPERIMENTAL

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

Drug: Nicotine saline infusion 0.00mcg/kg/s

nicotine infusion 0.24mcg/kg/s

EXPERIMENTAL

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

Drug: Nicotine infusion 0.24mcg/kg/s

nicotine infusion 0.096mcg/kg/s

EXPERIMENTAL

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

Drug: Nicotine infusion 0.096mcg/kg/s

nicotine infusion 0.048mcg/kg/s

EXPERIMENTAL

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

Drug: Nicotine infusion 0.048 mcg/kg/s

nicotine infusion 0.024mcg/kg/s

EXPERIMENTAL

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

Drug: Nicotine infusion 0.024mcg/kg/s

Interventions

Nicotine saline infusion 0.00mcg/kg/s DRUG

saline 0.00mcg/kg/s

Also known as: nicotine infusion

nicotine saline infusion 0.00mcg/kg/s

Nicotine infusion 0.24mcg/kg/s DRUG

nicotine 0.24mcg/kg/s

Also known as: nicotine infusion

nicotine infusion 0.24mcg/kg/s

Nicotine infusion 0.096mcg/kg/s DRUG

nicotine 0.096mcg/kg/s

Also known as: nicotine infusion

nicotine infusion 0.096mcg/kg/s

Nicotine infusion 0.048 mcg/kg/s DRUG

nicotine 0.048mcg/kg/s

Also known as: nicotine infusion

nicotine infusion 0.048mcg/kg/s

Nicotine infusion 0.024mcg/kg/s DRUG

nicotine 0.024mcg/kg/s

Also known as: nicotine infusion

nicotine infusion 0.024mcg/kg/s

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 (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.

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
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Veterans Affairs Hospital

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Mehmet Sofuoglu, M.D.,Ph.D.
• Organization: Yale University

mehmet.sofuoglu@yale.edu

203-932-5711

Study Officials

• Mehmet Sofuoglu, M.D.,Ph.D.

  Professor of Psychiatry

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: Single blind, placebo-controlled, mixed-design with nicotine delivery as a within-subjects factor.

Study Record Dates

• First Submitted: June 26, 2018
• First Posted: July 9, 2018
• Study Start: February 14, 2019
• Primary Completion: November 19, 2020
• Study Completion: November 19, 2020
• Last Updated: March 12, 2024
• Results First Posted: October 3, 2023

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)