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Nicotine Delivery Rate and Its Abuse Potential: Impact of Menthol

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ClinicalTrials.gov Identifier: NCT03580525
Recruitment Status : Not yet recruiting
First Posted : July 9, 2018
Last Update Posted : October 22, 2018
Sponsor:
Information provided by (Responsible Party):
Mehmet Sofuoglu, Yale University

Brief Summary:
A placebo-controlled study to enroll male and female tobacco smokers menthol (n=35) and non-menthol (n=35) 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).

Condition or disease Intervention/treatment Phase
Nicotine Dependence Drug: Nicotine saline infusion 0.00mcg/kg/s Drug: Nicotine infusion 0.24mcg/kg/s Drug: Nicotine infusion 0.096mcg/kg/s Drug: Nicotine infusion 0.048 mcg/kg/s Drug: Nicotine infusion 0.024mcg/kg/s Early Phase 1

Detailed Description:
A placebo-controlled study that will enroll male and female tobacco smokers menthol (n=35) and non-menthol (n=35) 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Single blind, placebo-controlled, mixed-design with nicotine delivery as a within-subjects factor.
Masking: Single (Participant)
Masking Description: Participant will not know nicotine dose or rate of infusion.
Primary Purpose: Health Services Research
Official Title: Nicotine Delivery Rate and Its Abuse Potential: Impact of Menthol
Estimated Study Start Date : December 1, 2018
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: nicotine saline infusion 0.00mcg/kg/s
0.00 mcg/kg/s The day order will be randomized per day
Drug: Nicotine saline infusion 0.00mcg/kg/s
saline 0.00mcg/kg/s
Other Name: nicotine infusion

Experimental: nicotine infusion 0.24mcg/kg/s
0.24mcg/kg/s The day order will be randomized per day
Drug: Nicotine infusion 0.24mcg/kg/s
nicotine 0.24mcg/kg/s
Other Name: nicotine infusion

Experimental: nicotine infusion 0.096mcg/kg/s
0.096mcg/kg/s The day order will be randomized per day
Drug: Nicotine infusion 0.096mcg/kg/s
nicotine 0.096mcg/kg/s
Other Name: nicotine infusion

Experimental: nicotine infusion 0.048mcg/kg/s
0.048mcg/kg/s The day order will be randomized per day
Drug: Nicotine infusion 0.048 mcg/kg/s
nicotine 0.048mcg/kg/s
Other Name: nicotine infusion

Experimental: nicotine infusion 0.024mcg/kg/s
0.048mcg/kg/s The day order will be randomized per day
Drug: Nicotine infusion 0.024mcg/kg/s
nicotine 0.024mcg/kg/s
Other Name: nicotine infusion




Primary Outcome Measures :
  1. Peak Changes on items of the Drug Effects Questionnaire (DEQ) [ Time Frame: up to 60 minutes post infusion ]
    The peak change in the intensity of subjective effects as measured by the DEQ: Drug effects questionnaire; Eleven questions with a minimum score of 0 to a maximum score of 100.



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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Female and male smokers, aged 18 to 30 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03580525


Contacts
Contact: Lance Barnes 203-932-5711 ext 4823 lance.barnes@yale.edu
Contact: Stacy Minnix, B.S. 203-932-5711 ext 4805 stacy.minnix@yale.edu

Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Mehmet Sofuoglu, M.D.,Ph.D. Professor of Psychiatry

Responsible Party: Mehmet Sofuoglu, Professor of Psychiatry, Yale University
ClinicalTrials.gov Identifier: NCT03580525     History of Changes
Other Study ID Numbers: HIC: 2000023289
First Posted: July 9, 2018    Key Record Dates
Last Update Posted: October 22, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Menthol
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipruritics
Dermatologic Agents