Back to resultsComparative Pharmacokinetics and Pharmacodynamics of Synthetic Nicotine
Primary Purpose
Nicotine Dependence, Nicotine Vaping
Status
Not yet recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
(S)-Nicotine
(R)- nicotine
Racemic nicotine
Sponsored by
About this trial
This is an interventional basic science trial for Nicotine Dependence focused on measuring Nicotine Pharmacokinetics, Nicotine Pharmacodynamics, Vaping, E-cigarettes
Eligibility Criteria
Inclusion Criteria: Healthy on the basis of medical history and limited physical examination. Current regular user of E-Cigarettes (≥ 15 days in the past 30 days) Exclusion Criteria: • Medications Use of medications that are inducers of nicotine metabolizing enzyme CYP2A6 (Example: rifampicin, carbamazepine, phenobarbital, and other anticonvulsant drugs). Use of sympatholytic medications for cardiovascular conditions including hypertension (Example: beta and alpha-blockers). Concurrent use of nicotine-containing medications (Example: nicotine patch, lozenge, gum). Any stimulant medications (example: Adderall) generally given for ADHD treatment. • Pregnancy Pregnancy (self-reported and urine pregnancy test) Breastfeeding (determined by self-report) Women of childbearing potential must be using an acceptable method of contraception Inability to read and write in English A known propylene glycol/vegetable glycerin allergy Uncomfortable with getting blood drawn
Sites / Locations
- Zuckerberg San Francisco General Hospital (ZSFG)
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
S-nicotine (tobacco) as the starting condition
R-nicotine (synthetic) as the starting condition
Racemic (50:50 S- and R- nicotine) as the starting condition
Arm Description
Participants will spend 8 hours in the hospital research ward where they will vape e-liquid containing 100% (S)-nicotine.
Participants will spend 8 hours in the hospital research ward where they will vape e-liquid containing 100% (R)-nicotine.
Participants will spend 8 hours in the hospital research ward where they will vape e-liquid containing 50% (S)-nicotine and 50% (R)-nicotine.
Outcomes
Primary Outcome Measures
Mean Nicotine Exposure Over Time
Plasma nicotine area under the concentrated time curve (AUC) (ng/ml*h)
Secondary Outcome Measures
Mean Amount of Nicotine Consumed Over Time
Nicotine self-administration determined by device weight change before and after use multiplied by the nicotine concentration in the e-liquid
Full Information
NCT ID
NCT05962229
First Posted
July 17, 2023
Last Updated
July 17, 2023
Sponsor
University of California, San Francisco
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT05962229
Brief Title
Comparative Pharmacokinetics and Pharmacodynamics of Synthetic Nicotine
Official Title
Comparative Pharmacokinetics and Pharmacodynamics of Synthetic Nicotine
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Institute on Drug Abuse (NIDA)
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
In a crossover study, experienced electronic cigarette users will vape 3 different forms of nicotine: natural (derived from tobacco), synthetic, or a 50:50 mixture of both natural and synthetic. The investigators will compare nicotine metabolism, cardiovascular effects, patterns of self-administration, and participants' feelings of craving/withdrawal and enjoyment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence, Nicotine Vaping
Keywords
Nicotine Pharmacokinetics, Nicotine Pharmacodynamics, Vaping, E-cigarettes
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Model Description
Within-subject, single-blinded crossover study. Participants will be randomized to the order of the 3 conditions using a Latin Square design.
Masking
Participant
Allocation
Randomized
Enrollment
18 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
S-nicotine (tobacco) as the starting condition
Arm Type
Experimental
Arm Description
Participants will spend 8 hours in the hospital research ward where they will vape e-liquid containing 100% (S)-nicotine.
Arm Title
R-nicotine (synthetic) as the starting condition
Arm Type
Experimental
Arm Description
Participants will spend 8 hours in the hospital research ward where they will vape e-liquid containing 100% (R)-nicotine.
Arm Title
Racemic (50:50 S- and R- nicotine) as the starting condition
Arm Type
Experimental
Arm Description
Participants will spend 8 hours in the hospital research ward where they will vape e-liquid containing 50% (S)-nicotine and 50% (R)-nicotine.
Intervention Type
Drug
Intervention Name(s)
(S)-Nicotine
Intervention Description
Participants will spend 8 hours in the hospital research ward and will vape e-liquid containing 100% (S)-nicotine. They will vape following a standardized session, followed by a 4 hour abstinence period. Participants will then vape as they wish (ad libitum) for 90 minutes.
Intervention Type
Drug
Intervention Name(s)
(R)- nicotine
Intervention Description
Participants will spend 8 hours in the hospital research ward and will vape e-liquid containing 100% (R)-nicotine. They will vape following a standardized session, followed by a 4 hour abstinence period. Participants will then vape as they wish (ad libitum) for 90 minutes.
Intervention Type
Drug
Intervention Name(s)
Racemic nicotine
Other Intervention Name(s)
50:50 mixture of (S)- and (R)-nicotine
Intervention Description
Participants will spend 8 hours in the hospital research ward and will vape e-liquid containing 50% (R)-nicotine and 50% (S)-nicotine. They will vape following a standardized session, followed by a 4 hour abstinence period. Participants will then vape as they wish (ad libitum) for 90 minutes.
Primary Outcome Measure Information:
Title
Mean Nicotine Exposure Over Time
Description
Plasma nicotine area under the concentrated time curve (AUC) (ng/ml*h)
Time Frame
Up to 7 hours
Secondary Outcome Measure Information:
Title
Mean Amount of Nicotine Consumed Over Time
Description
Nicotine self-administration determined by device weight change before and after use multiplied by the nicotine concentration in the e-liquid
Time Frame
120 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy on the basis of medical history and limited physical examination.
Current regular user of E-Cigarettes (≥ 15 days in the past 30 days)
Exclusion Criteria:
• Medications
Use of medications that are inducers of nicotine metabolizing enzyme CYP2A6 (Example: rifampicin, carbamazepine, phenobarbital, and other anticonvulsant drugs).
Use of sympatholytic medications for cardiovascular conditions including hypertension (Example: beta and alpha-blockers).
Concurrent use of nicotine-containing medications (Example: nicotine patch, lozenge, gum).
Any stimulant medications (example: Adderall) generally given for ADHD treatment.
• Pregnancy
Pregnancy (self-reported and urine pregnancy test)
Breastfeeding (determined by self-report)
Women of childbearing potential must be using an acceptable method of contraception
Inability to read and write in English
A known propylene glycol/vegetable glycerin allergy
Uncomfortable with getting blood drawn
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa Lawrence
Phone
628-206-4204
Email
lisa.lawrence@ucsf.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Armando Barraza
Phone
510-560-4842
Email
armando.barraza@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neal Benowitz, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zuckerberg San Francisco General Hospital (ZSFG)
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Lawrence
Phone
628-206-4204
Email
lisa.lawrence@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Armando Barraza
Phone
510-560-4842
Email
armando.barraza@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Neal Benowitz, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparative Pharmacokinetics and Pharmacodynamics of Synthetic Nicotine
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