Intravenous (IV) Nicotine Self Administration: Dose Ranging and Sex Differences in Smokers
Description
The proposed study will examine the threshold for nicotine self-administration using four different nicotine doses in male and female smokers with or without nicotine dependence (light and intermittent smokers). The investigators propose a double-blind, placebo-controlled study that will enroll 150 individuals with 32 male and 32 female smokers with a total of 64 completers, (16 of each group will be dependent and 16 will be non-dependent). Smokers will participate in four sessions: four test sessions. In each of the four test sessions, smokers will be randomly assigned to one of the four doses of nicotine (1.5, 3.0, 4.5, and 6.0 mcg/kg, or about 0.1, 0.2, 0.3, and 0.4 mg/70 kg). At the beginning of each test session, smokers will sample the assigned nicotine dose and placebo (saline) and then have the opportunity to choose between nicotine and placebo for a total of five choices over a 90-minute period. The main outcomes will be threshold dose (the minimum dose of nicotine that is self-administered more than placebo) and the slope of dose-response for nicotine self-administration (changes in nicotine self-administration per unit change in nicotine dose).
Study Start Date
October 2011
Estimated Completion Date
December 2016
Interventions
- Drug: Nicotine
- Drug: Saline
Specialties
- Internal Medicine: Clinical Pharmacology,Psychiatry
- Psychiatry: Neuro/Psych Pharmacol,Substance Abuse
- Pharmacy: Neuro/Psych pharmacology
MeSH Terms
- Behavior, Addictive
- Nicotine Addiction
- Smoker
- Tobacco Use Disorder
Study ID
Yale University -- 1010007514
Status
Unknown
Trial ID
Study Type
Interventional
Trial Phase
N/A
Enrollment Quota
64
Sponsor
Yale University
Inclusion Criteria
- Female and male smokers, aged 18 to 50 years, who have been smoking for at least a year
- for non-dependent smokers, urine cotinine levels < 200 ng/mL and not-fulfill DSM-IV criteria for nicotine dependence
- for dependent smokers, urine cotinine levels ? 200 ng/mL and fulfill DSM-IV criteria for nicotine dependence
- 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
- for women, not pregnant as determined by pregnancy screening, nor breast feeding, and using acceptable birth control methods.
Exclusion Criteria
- history of major medical illnesses that the physician investigator deems as contraindicated for the subject to be in the study
- regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics) and recent psychiatric diagnosis and treatment for Axis I disorders including major depression, bipolar affective disorder, schizophrenia or panic disorder and
- abuse of alcohol or any other recreational or prescription drugs.
Gender
Both
Ages
18 Years to 50 Years
Accepts Healthy Volunteers
No
Study Locations and Contact Information (1)
Study Location | Distance | Name | Phone | |
---|---|---|---|---|
Department of Veterans Affairs - West Haven, Connecticut | 15.6 miles | None | None | None |