Determining the nicotine threshold for smokers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.