Addictive Threshold of Nicotine

Conditions

• Smoking Addiction

Eligibility Criteria

Sex

ALL

Age

21 Years - 59 Years

Healthy Volunteers

Not accepted

Interventions

• Nicotine — DRUG
  Nicotine will be infused using a pump.
• Saline — OTHER
  Saline with be used to compare Nicotine, Saline will be infused using a pump

Study Details

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

Key Dates

Start date

Feb 27, 2024

Status verified

Jun 2026

Primary completion

Sep 1, 2027

Completion

Oct 1, 2027

Study Design

Enrollment

45 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

HEALTH_SERVICES_RESEARCH

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.

Primary Outcome Measure

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

Central Contacts

• Stacy Minnix, B.S
  203-932-5711
  [email protected]
• Mehmet S Sofuoglu, M.D.,Ph.D.
  203-932-5711
  [email protected]

Locations (1)

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