Back to resultsNicotine Differences in Smokers
Primary Purpose
Nicotine Dependence
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
0.05, 0.025, and 0.0125 mg nicotine/pulse of nicotine
Saline
Sponsored by
About this trial
This is an interventional health services research trial for Nicotine Dependence
Eligibility Criteria
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).
Sites / Locations
- Veterans Affairs HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Nicotine
saline
Arm Description
Experimental Session 2 will determine if smokers can discriminate 0.05, 0.025, and 0.0125 mg nicotine/pulse of nicotine from saline.
Saline will compared to different nicotine doses. Nicotine doses: 0.05, 0.025, and 0.0125 mg nicotine/pulse of nicotine from saline.
Outcomes
Primary Outcome Measures
Drug Effect Questionnaire
Liking effect
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05159934
Brief Title
Nicotine Differences in Smokers
Official Title
Nicotine Discrimination in Smokers
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 16, 2022 (Actual)
Primary Completion Date
September 28, 2023 (Anticipated)
Study Completion Date
October 2, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yale University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Model Description
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.
Masking
ParticipantInvestigator
Masking Description
Nicotine dose will be prepared by pharmacy
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nicotine
Arm Type
Active Comparator
Arm Description
Experimental Session 2 will determine if smokers can discriminate 0.05, 0.025, and 0.0125 mg nicotine/pulse of nicotine from saline.
Arm Title
saline
Arm Type
Placebo Comparator
Arm Description
Saline will compared to different nicotine doses. Nicotine doses: 0.05, 0.025, and 0.0125 mg nicotine/pulse of nicotine from saline.
Intervention Type
Drug
Intervention Name(s)
0.05, 0.025, and 0.0125 mg nicotine/pulse of nicotine
Intervention Description
Determine if smokers can discriminate 0.05, 0.025, and 0.0125 mg nicotine/pulse of nicotine from saline.
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
Saline will be use to determine if smokers can discriminate from the nicotine/pulse of nicotine and saline
Primary Outcome Measure Information:
Title
Drug Effect Questionnaire
Description
Liking effect
Time Frame
over 3 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mehmet Sofuoglu, M.D.,Ph.D.
Phone
203-932-5711
Ext
4809
Email
Mehmet.sofuoglu@yale.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehmet Sofuoglu, M.D.,Ph.D.
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Veterans Affairs Hospital
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brendan Sullivan
Phone
203-932-5711
Ext
3350
Email
brendan.sullivan@va.gov
First Name & Middle Initial & Last Name & Degree
Lori Parente
Phone
203-932-5711
Ext
3389
Email
lori.parente@va.gov
First Name & Middle Initial & Last Name & Degree
Mehmet Sofuoglu, M.D.,Ph.D.
12. IPD Sharing Statement
Learn more about this trial
Nicotine Differences in Smokers
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