Recruiting
Early Phase 1

Nicotine

Sponsor:

Yale University

Code:

NCT06096714

Conditions

Smoking Addiction

Eligibility Criteria

Sex: All

Age: 21 - 59

Healthy Volunteers: Not accepted

Interventions

Nicotine

Saline

Study Details

Brief summary:

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

Conditions

Smoking Addiction

Study ID

NCT06096714

Start date

Feb 27, 2024

Status verified date

Jun, 2026

Completion date

Oct 1, 2027

Anticipated

Primary completion date

Sep 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 59

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

45 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

active comparator: Nicotine

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).

placebo comparator: saline

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.

Interventions

Nicotine

Nicotine will be infused using a pump.

Saline

Saline with be used to compare Nicotine, Saline will be infused using a pump

Primary outcome measure

  • correctly identifying nicotine [ Time Frame: up to 8 weeks ]

Central Contacts and Locations

Central contacts

Stacy Minnix, B.S

203-932-5711stacy.minnix@yale.edu

Mehmet S Sofuoglu, M.D.,Ph.D.

203-932-5711Mehmet.sofuoglu@yale.edu

Locations

VA Healthcare System

Recruiting

West Haven, Connecticut, United States, 06516

Principal Investigator:

Mehmet Sofuoglu, M.D.,Ph.D.

More Information

Sponsor

Yale University

Last update posted

Jun 11, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-06-11.