Nicotine Reinforcement and Aversion in Young Adult Light Smokers
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Nicotine Reinforcement and Aversion in Young Adult Light Smokers|
- DEQ [ Time Frame: 3 years to complete ] [ Designated as safety issue: No ]ratings DEQ among smokers
|Study Start Date:||October 2011|
|Estimated Study Completion Date:||December 2020|
|Estimated Primary Completion Date:||June 2019 (Final data collection date for primary outcome measure)|
Active Comparator: Nicotine
subjects will be randomly assigned to one of the five doses of nicotine (0.0125, 0.025, 0.0.5, 0.1 and 0.2 mg/70 kg or about 0.18, 0.36, 0.7, 1.4 and 2.8 µg/kg). At the beginning of each experimental session, subjects will first sample the assigned nicotine dose and placebo (saline) condition that are randomly labeled as A or B. which may be nicotine or saline. This procedure will allow subjects to sample the nicotine and saline that will be available during that session. In addition, subjective and physiological responses to the sample nicotine dose and saline will be assessed.
(0.0125, 0.025, 0.0.5, 0.1 and 0.2 mg/70 kg or about 0.18, 0.36, 0.7, 1.4 and 2.8 µg/kg).
Other Name: IV nicotine
Placebo Comparator: Saline
Subjects will have sample A and B, one being nicotine and one being saline. The doses will be blinded from PI, subject and staff. The subject must choose A or B for the next ten choices.
5cc's of saline give at least once.
Other Name: Placebo
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 to 0.1 mg/70 kg.
Hypothesis #1B: The dose-effect curve for NSA will differ between males and females with relatively flat curve in female smokers.
Aim #2: To assess the threshold and dose-effect curve for the positive and negative/aversive subjective effects of IV nicotine at low doses and its relationship to nicotine reinforcement.
Hypothesis #2 A: The threshold for the positive effects will be between 0.0125 to 0.1 mg/70 kg, for the negative/aversive effect it will be ≥ 0.1 mg/70 kg.
Hypothesis #2B: Nicotine reinforcement will be positively correlated with the positive and negatively correlated with the negative/aversive subjective effects of IV nicotine.
Exploratory Aims: To examine the influence of nicotine clearance rate on nicotine reinforcement threshold and dose-effect curve.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01495819
|United States, Connecticut|
|Department of Veterans Affairs|
|West Haven, Connecticut, United States, 06516|
|Principal Investigator:||Mehmet Sofuoglu, M.D,Ph.D.||Yale University|