Clinical trial

Comparative Pharmacokinetics and Pharmacodynamics of Synthetic Nicotine

Name

22-36348

Description

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.

Trial arms

Trial start

2024-06-01

Estimated PCD

2025-09-01

Trial end

2025-09-01

Status

Not yet recruiting

Phase

Early phase I

Treatment

(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.

Arms:

R-nicotine (synthetic) as the starting condition, Racemic (50:50 S- and R- nicotine) as the starting condition, S-nicotine (tobacco) as the starting condition

(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.

Arms:

R-nicotine (synthetic) as the starting condition, Racemic (50:50 S- and R- nicotine) as the starting condition, S-nicotine (tobacco) as the starting condition

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.

Arms:

R-nicotine (synthetic) as the starting condition, Racemic (50:50 S- and R- nicotine) as the starting condition, S-nicotine (tobacco) as the starting condition

Other names:

50:50 mixture of (S)- and (R)-nicotine

Size

Primary endpoint

Mean Nicotine Exposure Over Time

Up to 7 hours

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Within-subject, single-blinded crossover study. Participants will be randomized to the order of the 3 conditions using a Latin Square design.', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 18, 'type': 'ESTIMATED'}}

Updated at

2024-05-01

1 organization

3 products

2 indications

Organization

University of California, San Francisco

Product

Indication

Indication

Product

Product