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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
Must not have
For women, pregnant as determined by pregnancy screening, or breastfeeding
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 8 weeks
Awards & highlights

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am not pregnant or breastfeeding.

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
2,503 Previous Clinical Trials
2,625,547 Total Patients Enrolled
1 Trials studying Smoking Addiction
218 Patients Enrolled for Smoking Addiction
Yale UniversityLead Sponsor
1,874 Previous Clinical Trials
2,953,520 Total Patients Enrolled
~24 spots leftby Jan 2027