A Phase 1 interventional study of Nicotrol in Drug Addiction and Nicotine Dependence, sponsored by National Institute on Drug Abuse (NIDA). Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-12-16.
Sponsored by National Institute on Drug Abuse (NIDA) · Phase 1, Interventional, and Other
Background:
Objectives:
Eligibility:
Design:
Objective:
The objective is to investigate the dose-response effect of nicotine on the top-down and bottom-up mechanisms of attention in cigarette smokers.
Study population:
Male and nonpregnant-female smokers 18 to 55 years of age.
Design:
This study is a double-blind, placebo controlled trial of nicotine or placebo nasal sprays. Participants have five visits: a training session and four experimental sessions. Each participant receives a test dose of the nasal spray immediately following the training session to ascertain tolerability and become familiarized with the effect of the spray. One dose (0, 1.0, 2.0 or 3.0 mg) of nicotine nasal spray is administered at the beginning of each experimental session followed by the test battery.
Outcome Measures:
Outcome measures are vital signs, ratings of mood and drug effect, and performance (accuracy, response time) on a test of selective attention.
968 studies on the registry are indexed under Tobacco Use Disorder; 128 are open to participants now.
This study's enrollment of 43 is below the median of 90 across 851 interventional studies indexed under Tobacco Use Disorder.
Browse Tobacco Use Disorder studies →National Institute on Drug Abuse (NIDA) is the lead sponsor of 388 studies on the registry; 19 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.
Counted across the registry records on this site, refreshed daily.
18-55 year old male and female cigarette smokers
smoke a minimum of 10 cigarettes per day for at least 1 year
--Drug Use Survey
estimated IQ score greater than or equal to 85
--Weschsler Abbreviated Scale of Intelligence (WASI; raw vocabulary cutoff 49)
urine cotinine concentration greater than or equal 100 ng/ml
EXCLUSION CRITERIA:
use of any illicit drugs more than twice per week during the past month
--Drug Use Survey (items 2-4)
pregnant or nursing
--Urine pregnancy test
HIV positive
--Oral HIV test
Past history of schizophrenia or bipolar disorder.
Current Major Depression Disorder, Diagnosis or treatment for Major Depressive Disorder in past 12 months. (H\&P)
Evidence of current ADHD by current diagnosis or medication or score on Adult Symptom Rating Scale; (> 16 on pt A or B must be evaluated by a counselor)
vital signs (must be outside these parameters on more than two occasions separated by at least one day):
Performance (accuracy response time) on a test of selective attention.
Vital signs, ratings of mood and drug effect.
This study is completed, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.
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National Institute on Drug Abuse (NIDA)