Nicotine Reinforcement and Aversion in Young Adult Light Smokers
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|ClinicalTrials.gov Identifier: NCT01495819|
Recruitment Status : Recruiting
First Posted : December 20, 2011
Last Update Posted : January 30, 2018
|Condition or disease||Intervention/treatment||Phase|
|Nicotine Addiction||Drug: Saline Drug: Nicotine||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||64 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Nicotine Reinforcement and Aversion in Young Adult Light Smokers|
|Actual Study Start Date :||January 4, 2017|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||December 2020|
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
- DEQ [ Time Frame: 3 years to complete ]ratings DEQ among smokers
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01495819
|United States, Connecticut|
|Department of Veterans Affairs||Recruiting|
|West Haven, Connecticut, United States, 06516|
|Contact: Lance Barnes 203-937-4823 email@example.com|
|Contact: Marcedes Coffman, M.A. 203-932-5711 ext 4841 firstname.lastname@example.org|
|Principal Investigator: Mehmet Sofuoglu, M.D., Ph.D.|
|Principal Investigator:||Mehmet Sofuoglu, M.D,Ph.D.||Yale University|