NCT06096714 Addictive Threshold of Nicotine
| NCT ID | NCT06096714 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Yale University |
| Condition | Smoking Addiction |
| Study Type | INTERVENTIONAL |
| Enrollment | 45 participants |
| Start Date | 2024-02-27 |
| Primary Completion | 2027-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 45 participants in total. It began in 2024-02-27 with a primary completion date of 2027-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To determine the nicotine threshold dose(s) for discrimination, subjective-rewarding effects, -and reinforcement in smokers with different levels of dependence.
Eligibility Criteria
Inclusion Criteria: * to contact their primary care provider when necessary. * Adults, aged 21 to 59 years. Individuals less than 21 will be excluded because the minimum age for purchasing tobacco products is 21 in our state. The upper age is set at 59 because there are no previous IV nicotine studies that enrolled smokers over the age of 59. * Smoking at least for one year and more frequently than once a week, smoking status confirmed with a semi-quantitative urine nicotine test. Smokers will be stratified based on the level of dependence, assessed with the FTND scores (Heatherton et al. 1991) (low or no dependence 4 and moderate or high level of dependence 5. * In good health as verified by medical history, screening examination, and screening laboratory tests. * For women, report using acceptable birth control methods. Exclusion Criteria: * History of major medical or psychiatric disorders that the physician investigator deems as contraindicated for the participant to be in the study * regular current use of certain psychotropic medications (such as mood stabilizers, antipsychotics, or anxiolytics being prescribed to treat bipolar disorder, psychosis or anxiety spectrum disorders, respectively) * current untreated alcohol or substance use disorder for any other recreational or prescription drugs other than nicotine * for women, pregnant as determined by pregnancy screening, or breastfeeding * seeking (or undergoing) treatment for tobacco dependence or smoking.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06096714 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 59 Years, studying Smoking Addiction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06096714 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06096714 currently recruiting?
Yes, NCT06096714 is actively recruiting participants. Contact the research team at stacy.minnix@yale.edu for enrollment information.
Where is the NCT06096714 trial being conducted?
This trial is being conducted at West Haven, United States.
Who is sponsoring the NCT06096714 clinical trial?
NCT06096714 is sponsored by Yale University. The trial plans to enroll 45 participants.
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