Smoking Cessation
Conditions
Brief summary
To establish a dose-effect curve for nicotine's abuse potential as a function of nicotine dose and delivery rate. Pulsed IV nicotine administration will be used as it closely matches nicotine delivery by inhaled tobacco use.
Detailed description
Both sub-studies will enroll male and female tobacco cigarette smokers. This study will examine the feasibility of the proposed study parameters in a total of 10 completers. In a crossover design, participants will be tested under 5 conditions: 0.2 mg nicotine delivered over 2.5 minutes (5 pulsed-nicotine deliveries), 0.2mg nicotine delivered over 10 min (20 pulsed-nicotine deliveries), 1.0 mg nicotine delivered over 2.5 minutes (5 pulsed-nicotine deliveries) and 1.0 mg nicotine delivered over 10 min (20 pulsed-nicotine deliveries). The main outcome measures will be self-report drug effects and urges to smoke cigarettes. The investigators hypothesize that the abuse potential and alleviation of smoking urges are produced by nicotine as a function of nicotine dose and delivery rate. This study is complete with 13 enrolled and 10 completers
Interventions
DRUGNicotine 0.2mcg/kg/s and 1.0mcg/kg/s
Nicotine infusion 0.2 mg nicotine delivered over 2.5 minutes (5 pulsed-nicotine deliveries), 0.2mg nicotine delivered over 10 min (20 pulsed-nicotine deliveries), 1.0 mg nicotine delivered over 2.5 minutes (5 pulsed-nicotine deliveries) and 1.0 mg nicotine delivered over 10 min (20 pulsed-nicotine deliveries).
Sponsors
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Investigator)
Masking description
Participant will not know nicotine dose or rate of infusion.
Intervention model description
placebo-controlled, mixed-design with nicotine dose as a between-subject and nicotine delivery rate as a within-subject factor.
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* Female and male smokers, aged 18 to 35 years, who have been smoking tobacco cigarettes for at least a year * smoke ≥ 5 and less than 20 cigarettes per day * urine cotinine levels \> 100 ng/mL consistent with nicotine intake of an active smoker * not seeking treatment at the time of the study for nicotine dependence * in good health as verified by medical history, screening examination, and screening laboratory tests; and 6) for women, not pregnant as determined by pregnancy screening, nor breast feeding, and using acceptable birth control methods.
Exclusion criteria
* History of major medical or psychiatric disorders that the physician investigator deems as contraindicated for the subject to be in the study * regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics) * current alcohol or substance dependence for any other recreational or prescription drugs other than nicotine * use of e-cigarettes more than 10 days in the past 30 days * urine drug screening indicating recent illicit drugs use (with the exception of marijuana)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Heart rate will be used to see the dose effect | During nicotine infusion max of ten minutes | the dose-effect curves of nicotine dose and delivery rate in heart rate |
Countries
United States
Outcome results
None listed