Comparative Pharmacokinetics and Pharmacodynamics of Synthetic Nicotine

Nicotine Dependence Clinical Trial

Official title:

Comparative Pharmacokinetics and Pharmacodynamics of Synthetic Nicotine

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05962229
• Other study ID #: 22-36348
• Secondary ID: 1R01DA057282-01
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: June 1, 2024
• Est. completion date: September 2025

Study information

• Verified date: April 2024
• Source: University of California, San Francisco
• Contact: Lisa Lawrence
• Phone: 628-206-4204
• Email: lisa.lawrence[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 18
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Nicotine Dependence
• Tobacco Use Disorder

Intervention

Drug:
• (S)-Nicotine
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.
• (R)- nicotine
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.
• Racemic nicotine
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.

Locations

Country	Name	City	State
United States	Zuckerberg San Francisco General Hospital (ZSFG)	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Nicotine Exposure Over Time	Plasma nicotine area under the concentrated time curve (AUC) (ng/ml*h)	Up to 7 hours
Secondary	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	120 minutes