The Effect of Nicotine Delivery Rate on Reinforcement

• Status: Completed
• Trial end date: 2018-01-29
• Target enrollment: 0
• Participant gender: All

Summary

The dose-effect curve to estimate a threshold delivery rate for reinforcement. The project addresses the FDA Center for Tobacco Products (CTP) interest #1: Nicotine dependence threshold among youth and adults and impact of nicotine reduction on tobacco product use behavior (e.g., topography, compensation, switching, multiple use, initiation, cessation and relapse). IV nicotine, in contrast to ECs, can deliver precise, reproducible dosing, which is necessary for accurately assessing dose-response and threshold effects. The estimated threshold for reinforcement will establish a benchmark for evaluating the addictive potential of ECs and other inhaled nicotine products.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Treatments: Nicotine

Criteria

Inclusion Criteria:

1. Female and male smokers that smoke ≥ 5 cigarettes per day for the past year

2. aged 18 to 30 years

3. urine cotinine levels > 100 ng/mL consistent with nicotine intake of an active smoker (23)

4. not seeking treatment at the time of the study for nicotine dependence

5. in good health as verified by medical history, screening examination, and screening laboratory tests

6. for women, not pregnant as determined by pregnancy screening, nor breast feeding, and using acceptable birth control methods.

Exclusion Criteria:

1. history of major medical or psychiatric disorders that the physician investigator deems as contraindicated for the subject to be in the study

2. regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics)

3. current alcohol or substance dependence for any other recreational or prescription drugs other than nicotine

4. urine drug screening indicating recent illicit drugs use (with the exception of marijuana).