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Synthetic Nicotine Comparison for Nicotine Addiction

Phase 1

Waitlist Available

Led By Neal Benowitz, MD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 120 minutes

Awards & highlights

Study Summary

This trial will compare the effects of vaping 3 different kinds of nicotine on metabolism, heart health, behavior, cravings, and enjoyment.

Who is the study for?

This trial is for regular e-cigarette users who are healthy based on medical history and a physical exam. It's not for those uncomfortable with blood draws, on certain heart meds or nicotine replacements, allergic to e-cig ingredients, pregnant/breastfeeding women not using contraception, non-English readers/writers, or stimulant medication users.Check my eligibility

What is being tested?

The study tests how the body processes three types of nicotine (natural from tobacco, synthetic, and a mix) in experienced vapers. It looks at metabolism rates, cardiovascular effects, usage patterns and feelings related to craving/withdrawal and pleasure.See study design

What are the potential side effects?

Potential side effects may include typical reactions to vaping such as throat irritation or coughing. Since it involves nicotine use; addiction risk persists. Cardiovascular changes like increased heart rate could occur due to the nature of substances tested.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 120 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~120 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and 120 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mean Nicotine Exposure Over Time

Secondary outcome measures

Mean Amount of Nicotine Consumed Over Time

Trial Design

3Treatment groups

Experimental Treatment

Group I: S-nicotine (tobacco) as the starting conditionExperimental Treatment3 Interventions

Participants will spend 8 hours in the hospital research ward where they will vape e-liquid containing 100% (S)-nicotine.

Group II: Racemic (50:50 S- and R- nicotine) as the starting conditionExperimental Treatment3 Interventions

Participants will spend 8 hours in the hospital research ward where they will vape e-liquid containing 50% (S)-nicotine and 50% (R)-nicotine.

Group III: R-nicotine (synthetic) as the starting conditionExperimental Treatment3 Interventions

Participants will spend 8 hours in the hospital research ward where they will vape e-liquid containing 100% (R)-nicotine.

Do I qualify?Apply below to find out

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor

2,500 Previous Clinical Trials

15,236,453 Total Patients Enrolled

2 Trials studying Nicotine Addiction

991 Patients Enrolled for Nicotine Addiction

National Institute on Drug Abuse (NIDA)NIH

2,464 Previous Clinical Trials

2,618,575 Total Patients Enrolled

15 Trials studying Nicotine Addiction

2,130 Patients Enrolled for Nicotine Addiction

Neal Benowitz, MDPrincipal InvestigatorUniversity of California, San Francisco

2 Previous Clinical Trials

20 Total Patients Enrolled

Media Library

S-nicotine (tobacco) as the starting condition Clinical Trial Eligibility Overview. Trial Name: NCT05962229 — Phase 1

Nicotine Addiction Research Study Groups: 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

Nicotine Addiction Clinical Trial 2023: S-nicotine (tobacco) as the starting condition Highlights & Side Effects. Trial Name: NCT05962229 — Phase 1

S-nicotine (tobacco) as the starting condition 2023 Treatment Timeline for Medical Study. Trial Name: NCT05962229 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it permissible for me to join in this medical research?

"To be eligible for this research initiative, participants must have a nicotine addiction and reside between the ages of 21 to 65. The protocol is recruiting approximately 18 volunteers."

Answered by AI

Is the FDA sanctioning S-nicotine (tobacco) as a baseline intervention?

"The safety of S-nicotine (tobacco) as the initial treatment was rated a 1 by Power due to its Phase 1 status, which implies that there is restricted data testifying to its efficacy and security."

Answered by AI

Does this clinical trial accept participants above the age of 40?

"To be eligible for inclusion in this trial, applicants must be between the ages of 21 and 65. For younger patients aged 18 or below, we have 6 clinical studies available while those over age 65 can choose from 79 different trials."

Answered by AI

Are new participants still being accepted for this research project?

"Clinicaltrials.gov information indicates this medical study is no longer recruiting patients, with the original post dating back to September 1st 2023 and the last update occurring on July 17th of that year. Nevertheless, there are 114 other clinical trials currently accepting participants at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Comparative Pharmacokinetics and Pharmacodynamics of Synthetic Nicotine

2024. "Comparative Pharmacokinetics and Pharmacodynamics of Synthetic Nicotine". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05962229.