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

NCT01495819

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 Email
Department of Veterans Affairs - West Haven, Connecticut 15.6 miles None None None

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