Status:
COMPLETED
Nicotine Reinforcement and Aversion in Young Adult Light Smokers
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Nicotine Addiction
Eligibility:
All Genders
18-30 years
Phase:
EARLY_PHASE1
Brief Summary
The proposed study will examine the threshold for nicotine self-administration (NSA) using five different nicotine doses in young adult male and female non-dependent smokers (light and intermittent sm...
Detailed Description
Aim #1: To assess the threshold reinforcing dose and dose-effect curve for IV NSA at low doses in young adult LITS. Hypothesis #1A: The threshold reinforcing doses for IV NSA will be between 0.0125 t...
Eligibility Criteria
Inclusion
- Inclusion criteria: 1) Female and male smokers, aged 18 to30 years, who have been smoking for at least a year, and a life-time consumption of at least 100 cigarettes; 2) smoke more frequently than once a week and ≤5 cpd; 3) FTND score \<3 indicating no or minimal evidence for nicotine dependence; 4) urine cotinine levels \>100 ng/mL indicating smoking status and a level \<1000 mg/mL consistent with nicotine intake of LITS; 5) not seeking treatment at the time of the study for nicotine dependence; 6) in good health as verified by medical history, screening examination, and screening laboratory tests; 7) 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 illnesses that the physician investigator deems as contraindicated for the subject to be in the study; 2) requirement of any form of regular psychotropic medication (antidepressants, antipsychotics, or anxiolytics) or psychiatric diagnosis and treatment for psychiatric disorders including major depression, bipolar disorder, schizophrenia in the past 6 months; and 3) current dependence to alcohol or any other recreational or prescription drugs and; 4) daily use of smokeless tobacco products or exclusive daily use of e-cigarettes (non-daily users will be included).
Exclusion
Key Trial Info
Start Date :
January 4 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2020
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT01495819
Start Date
January 4 2017
End Date
March 31 2020
Last Update
August 31 2021
Active Locations (1)
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1
Department of Veterans Affairs
West Haven, Connecticut, United States, 06516