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Nicotine Thresholds for Smoking Addiction

Phase < 1
Recruiting
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adults, aged 21 to 59 years
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 8 weeks
Awards & highlights

Study Summary

This trial tests how much nicotine smokers need to feel a reward, and how that differs for smokers of different levels of dependency.

Who is the study for?
This trial is for adults aged 21 to 59 who have been smoking at least once a week for over a year. Participants must be in good health, not seeking treatment for tobacco dependence, and women should use birth control. Smokers will be categorized by their level of addiction using the FTND scores.Check my eligibility
What is being tested?
The study aims to find out the lowest amount of nicotine that can still produce noticeable effects, feelings of reward, and desire to continue use in smokers with varying levels of addiction.See study design
What are the potential side effects?
While specific side effects are not listed here, nicotine can typically cause dizziness, nausea, increased heart rate or blood pressure changes among others. The exact side effects will depend on the dose used in this trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 21 and 59 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
correctly identifying nicotine

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: NicotineActive Control2 Interventions
Adaptation Session followed by 4 Test Days. The Adaptation Session will familiarize the participants with study procedures. In each Test Day, a different nicotine dose (0.1, 0.05, 0.025, and 0.0125 mg nicotine/pulse) will be compared to saline for nicotine discrimination, subjective effects, and reinforcement. Participants will first sample the assigned nicotine dose and saline, followed by 4 trials to test their ability to discriminate it from saline. This will be followed by 4 Choice trials where participants will be able to choose between nicotine (at the session-assigned dose) or saline (A or B).
Group II: salinePlacebo Group2 Interventions
Subjects will have sample A and B, one being nicotine and one being saline. The doses will be blinded from PI, subject and staff. The subject must choose A or B for the next ten choices.

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,470 Previous Clinical Trials
2,619,695 Total Patients Enrolled
1 Trials studying Smoking Addiction
218 Patients Enrolled for Smoking Addiction
Yale UniversityLead Sponsor
1,853 Previous Clinical Trials
2,738,525 Total Patients Enrolled

Frequently Asked Questions

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

Does your research encompass individuals of elder age?

"The requirements for participation in this clinical trial necessitate that patients be between 21 and 59 years old."

Answered by AI

Could I qualify for inclusion in this research endeavor?

"Patient selection for the trial necessitates that they have a smoking habit and are between 21 to 59 years old. The experiment is looking to procure 36 individuals."

Answered by AI

Is the recruitment process for this research still ongoing?

"As per clinicaltrials.gov, this trial is no longer accepting applicants. The initial post date was November 1st 2023 and it last saw an update on October 17th of the same year; nonetheless, 51 other trials are currently searching for participants."

Answered by AI
~24 spots leftby Jan 2027