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Nicotine Differences in Smokers

NCT ID: NCT05159934

Last Updated: 2023-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-16

Study Completion Date

2023-08-01

Brief Summary

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The primary aim of this project is to determine the threshold dose of nicotine, which the smokers will be able to differentiate from placebo (saline). Will use IV pulsed-nicotine infusion that closely matches nicotine delivery by inhaled tobacco use (i.e., tobacco cigarette or electronic cigarette), allowing precise and reproducible nicotine delivery. Four nicotine doses (0.1, 0.05, 0.025, and 0.0125 mg nicotine/pulse) which are within the range of nicotine doses that are delivered by cigarettes with very low to regular nicotine content. These doses will be delivered as a cluster of 4 pulsed-nicotine infusions of 2 sec duration with a 28 sec interval between each dose.

Detailed Description

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Twenty participants will have 2 Experimental Session on 2 separate days. Experimental Session 1 will determine if smokers can reliably discriminate 0.1mg nicotine/pulse nicotine from saline. Experimental Session 2 will determine if smokers can discriminate 0.05, 0.025, and 0.0125 mg nicotine/pulse of nicotine from saline.

Hypothesis: The threshold for discrimination will be 0.05 mg nicotine/pulse and the doses below that (0.025, and 0.0125 mg nicotine/pulse) will be subthreshold.

Exploratory Aim: To explore the relationship between the threshold for subjective drug effects and drug discrimination.

Conditions

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Nicotine Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Twenty participants will have 2 Experimental Session on 2 separate days. Experimental Session 1 will determine if smokers can reliably discriminate 0.1mg nicotine/pulse nicotine from saline. Experimental Session 2 will determine if smokers can discriminate 0.05, 0.025, and 0.0125 mg nicotine/pulse of nicotine from saline.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Investigators
Nicotine dose will be prepared by pharmacy

Study Groups

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Nicotine

Experimental Session 2 will determine if smokers can discriminate 0.05, 0.025, and 0.0125 mg nicotine/pulse of nicotine from saline.

Group Type ACTIVE_COMPARATOR

Saline

Intervention Type DRUG

Saline will be use to determine if smokers can discriminate from the nicotine/pulse of nicotine and saline

saline

Saline will compared to different nicotine doses. Nicotine doses: 0.05, 0.025, and 0.0125 mg nicotine/pulse of nicotine from saline.

Group Type PLACEBO_COMPARATOR

0.05, 0.025, and 0.0125 mg nicotine/pulse of nicotine

Intervention Type DRUG

Determine if smokers can discriminate 0.05, 0.025, and 0.0125 mg nicotine/pulse of nicotine from saline.

Interventions

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0.05, 0.025, and 0.0125 mg nicotine/pulse of nicotine

Determine if smokers can discriminate 0.05, 0.025, and 0.0125 mg nicotine/pulse of nicotine from saline.

Intervention Type DRUG

Saline

Saline will be use to determine if smokers can discriminate from the nicotine/pulse of nicotine and saline

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Female and male smokers, aged 18 to 65 years veterans and non-veterans who have been smoking tobacco cigarettes for at least a year
* smoke ≥ 5 cigs/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
* 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

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yale University

OTHER

Sponsor Role lead

Responsible Party

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Mehmet Sofuoglu

Professor of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Veterans Affairs Hospital

West Haven, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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MS063

Identifier Type: -

Identifier Source: org_study_id