The Effect of Nicotine Delivery Rate on Reinforcement
| Status: | Completed |
|---|---|
| Conditions: | Smoking Cessation |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 30 |
| Updated: | 10/24/2018 |
| Start Date: | January 5, 2017 |
| End Date: | January 29, 2018 |
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.
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.
A placebo-controlled study that will recruit male and female nicotine dependent smokers/EC
users (n=18) to complete four separate experimental sessions. Each session will include one
randomly assigned infusion that will be either saline or a single dose of nicotine (1 mg per
70 kg body weight) delivered at three different infusion rates, rapid, moderate or slow
(0.24, 0.048 or 0.024 mcg per kg body weight per second). A total infusion duration of 10 min
will be maintained during each session by adding saline infusions of variable duration after
nicotine delivery. This will be achieved by two separate infusion pumps, one for saline and
one for nicotine. For example, the rapid 0.24 mcg/kg/s condition will include a 1 min
infusion of nicotine followed by a 9 min infusion of saline. The subjects will be blinded to
the infusion pump procedures. The rapid delivery rate, which we have used in our prior
studies, induces positive subjective drug effects and suppresses symptoms of nicotine
withdrawal. The moderate delivery rate,0.048 mcg/kg/s, approximates the rate of nicotine
intake encountered while smoking a typical cigarette over 5 min (4). The slowest nicotine
delivery rate, 0.024mcg/kg/s, was chosen to approximate the rate of nicotine intake
encountered while using a newer EC (5).
users (n=18) to complete four separate experimental sessions. Each session will include one
randomly assigned infusion that will be either saline or a single dose of nicotine (1 mg per
70 kg body weight) delivered at three different infusion rates, rapid, moderate or slow
(0.24, 0.048 or 0.024 mcg per kg body weight per second). A total infusion duration of 10 min
will be maintained during each session by adding saline infusions of variable duration after
nicotine delivery. This will be achieved by two separate infusion pumps, one for saline and
one for nicotine. For example, the rapid 0.24 mcg/kg/s condition will include a 1 min
infusion of nicotine followed by a 9 min infusion of saline. The subjects will be blinded to
the infusion pump procedures. The rapid delivery rate, which we have used in our prior
studies, induces positive subjective drug effects and suppresses symptoms of nicotine
withdrawal. The moderate delivery rate,0.048 mcg/kg/s, approximates the rate of nicotine
intake encountered while smoking a typical cigarette over 5 min (4). The slowest nicotine
delivery rate, 0.024mcg/kg/s, was chosen to approximate the rate of nicotine intake
encountered while using a newer EC (5).
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).
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