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Nicotine Dosing for Nicotine Addiction

Phase < 1
Recruiting
Led By Mehmet Sofuoglu, M.D.,Ph.D
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female and male, aged 21 to 55 years
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to five years
Awards & highlights

Study Summary

This trial will study the effects of different levels of nicotine on smokers' urges and withdrawal symptoms.

Who is the study for?
This trial is for adults aged 21 to 55 who smoke cigarettes daily, as confirmed by urine tests. Participants must be in good health and not seeking treatment for tobacco dependence. Women should use birth control methods. People with major medical or psychiatric issues, substance abuse other than nicotine, or risks for vaping-related lung injury cannot join.Check my eligibility
What is being tested?
The study investigates how different doses and delivery rates of IV pulsed-nicotine affect its potential for abuse versus its benefits on reducing smoking urges and withdrawal symptoms. It mimics the nicotine hit from smoking tobacco.See study design
What are the potential side effects?
While specific side effects are not listed here, generally nicotine can cause dizziness, nausea, increased heart rate or blood pressure changes among others. The trial will monitor these effects closely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 21 and 55 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to five years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to five years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Drug Effects Questionnaire mean score

Trial Design

2Treatment groups
Active Control
Group I: delivery rate for nicotine dose 1mg/70kgActive Control1 Intervention
delivery rate 50,35, 16.6 and 12.5 ug per second
Group II: Delivery rate for nicotine dose 0.2mg/70kgActive Control1 Intervention
delivery rate 10,5, 3.3 and 2.5

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,848 Previous Clinical Trials
2,737,748 Total Patients Enrolled
4 Trials studying Nicotine Addiction
194 Patients Enrolled for Nicotine Addiction
Mehmet Sofuoglu, M.D.,Ph.DPrincipal InvestigatorYale University

Media Library

Nicotine (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05176418 — Phase < 1
Nicotine Addiction Research Study Groups: delivery rate for nicotine dose 1mg/70kg, Delivery rate for nicotine dose 0.2mg/70kg
Nicotine Addiction Clinical Trial 2023: Nicotine Highlights & Side Effects. Trial Name: NCT05176418 — Phase < 1
Nicotine (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05176418 — Phase < 1

Frequently Asked Questions

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

Who is eligible to enroll in this medical experiment?

"Candidates between the ages of 21 and 55, who present with nicotine dependence, are eligible to join this medical trial. To date, 70 individuals have been enrolled in the study."

Answered by AI

Are investigators currently enrolling participants in this research?

"The data posted on clinicaltrials.gov specifies that this medical experiment is actively searching for participants as of the date of this writing. It was first published in May 2022 and its information has been updated most recently in July 2022."

Answered by AI

What is the current enrollment size of this medical experiment?

"Affirmative. Clinicaltrials.gov reports that this trial, which was initially posted on May 30th 2022, is still recruiting patients. 70 individuals need to be enrolled in a single medical facility for the study's completion."

Answered by AI

Does this research encompass individuals who are in the geriatric age range?

"This clinical trial is only eligible for patients between the ages of 21 to 55. Conversely, 8 studies are available for minors and 131 studies accommodate elderly participants."

Answered by AI

What other research has been conducted to measure the efficacy of a 0.2mg/70kg nicotine dose?

"Presently, 71 clinical trials for Delivery rate for nicotine dose 0.2mg/70kg are underway with 5 of them in Phase 3. While the majority are based out of Augusta, Georgia there is a total 204 study locations to choose from."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
IV Pulsed-Nicotine as a Model of Smoking: The Effects of Dose and Delivery Rate
Mehmet Sofuoglu 2022. "IV Pulsed-Nicotine as a Model of Smoking: The Effects of Dose and Delivery Rate". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05176418.
~10 spots leftby Aug 2024
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