Determining the nicotine threshold for smokers
Addictive Threshold of Nicotine
This study is testing how different amounts of nicotine affect smokers' choices and feelings to see what levels are most rewarding for them.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 21 Years to 59 Years |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 1 site (West Haven, Connecticut) |
| Trial ID | NCT06096714 on ClinicalTrials.gov |
What this trial studies
This project aims to identify the nicotine threshold doses that influence discrimination, subjective-rewarding effects, and reinforcement in smokers with varying levels of dependence. Participants will undergo an Adaptation Session followed by four Test Days, where they will be exposed to different nicotine doses and saline. The study will assess their ability to distinguish between nicotine and saline, as well as their preferences for nicotine over saline. Reinforcement will be measured by the percentage of nicotine choices made during the trials, while subjective effects will be evaluated using a standardized questionnaire.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 to 59 who have been smoking for at least one year and have varying levels of nicotine dependence.
Not a fit: Patients with major medical or psychiatric disorders that could contraindicate participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help tailor smoking cessation strategies by understanding how different nicotine doses affect smokers' behavior and preferences.
How similar studies have performed: Other studies have explored nicotine dependence and its effects, but this specific approach to determining threshold doses is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
West Haven, Connecticut
- VA Healthcare System — West Haven, Connecticut, United States (Recruiting)
Study contacts
- Study coordinator: Stacy Minnix, B.S
- Email: stacy.minnix@yale.edu
- Phone: 203-932-5711
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.