A Phase 1 interventional study of 0.05, 0.025, and 0.0125 mg nicotine/pulse of nicotine and Saline in Nicotine Dependence, sponsored by Yale University. Completed at 1 site in United States. Open to participants aged 21 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-12-11.
Sponsored by Yale University · Phase 1, Interventional, and Health services research
The primary aim of this project is to determine the threshold dose of nicotine, which the smokers will be able to differentiate from placebo (saline). Will use IV pulsed-nicotine infusion that closely matches nicotine delivery by inhaled tobacco use (i.e., tobacco cigarette or electronic cigarette), allowing precise and reproducible nicotine delivery. Four nicotine doses (0.1, 0.05, 0.025, and 0.0125 mg nicotine/pulse) which are within the range of nicotine doses that are delivered by cigarettes with very low to regular nicotine content. These doses will be delivered as a cluster of 4 pulsed-nicotine infusions of 2 sec duration with a 28 sec interval between each dose.
Twenty participants will have 2 Experimental Session on 2 separate days. Experimental Session 1 will determine if smokers can reliably discriminate 0.1mg nicotine/pulse nicotine from saline. Experimental Session 2 will determine if smokers can discriminate 0.05, 0.025, and 0.0125 mg nicotine/pulse of nicotine from saline.
Hypothesis: The threshold for discrimination will be 0.05 mg nicotine/pulse and the doses below that (0.025, and 0.0125 mg nicotine/pulse) will be subthreshold.
Exploratory Aim: To explore the relationship between the threshold for subjective drug effects and drug discrimination.
968 studies on the registry are indexed under Tobacco Use Disorder; 128 are open to participants now.
This study's enrollment of 11 is below the median of 90 across 851 interventional studies indexed under Tobacco Use Disorder.
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Exclusion criteria:
Experimental Session 2 will determine if smokers can discriminate 0.05, 0.025, and 0.0125 mg nicotine/pulse of nicotine from saline.
Drug: Saline
Saline will compared to different nicotine doses. Nicotine doses: 0.05, 0.025, and 0.0125 mg nicotine/pulse of nicotine from saline.
Drug: 0.05, 0.025, and 0.0125 mg nicotine/pulse of nicotine
Determine if smokers can discriminate 0.05, 0.025, and 0.0125 mg nicotine/pulse of nicotine from saline.
Saline will be use to determine if smokers can discriminate from the nicotine/pulse of nicotine and saline
Drug Effect Questionnaire
Liking effect
Time frame: over 3 hours
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Yale University