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New treatment option for Nicotine Dependence
Official title Comparative Pharmacokinetics and Pharmacodynamics of Synthetic Nicotine
ClinicalTrials.gov ID: NCT05962229
What this study is testing
What is (S)-Nicotine?
(S)-Nicotine is an investigational medicine, being studied as a potential treatment for nicotine dependence.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 65. Healthy volunteers may be eligible.
You may be able to join if
- Healthy on the basis of medical history and limited physical examination.
- Current regular user of E-Cigarettes (≥ 15 days in the past 30 days)
You likely can't join if
- Medications
- Use of medications that are inducers of nicotine metabolizing enzyme CYP2A6 (Example: rifampicin, carbamazepine, phenobarbital, and other...
- 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
See the full eligibility 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)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.