Addictive Threshold of Nicotine

Recruiting now · Early Phase 1

Conditions studied: Smoking Addiction

In brief

To determine the nicotine threshold dose(s) for discrimination, subjective-rewarding effects, -and reinforcement in smokers with different levels of dependence.

Key facts

Study ID

NCT06096714

Run by

Yale University

People needed

45

Starts

2024-02-27

Expected to finish

2027-10-01

Last updated by the study team

2026-06-11

Who can join

Age: 21 and older, up to 59. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• VA Healthcare System — West Haven, Connecticut, United States (enrolling)

Full record on ClinicalTrials.gov

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