Status:
COMPLETED
Assessing Top Down and Bottom Up Attention Mechanisms in Smokers Using Nicotine Nasal Spray
Lead Sponsor:
National Institute on Drug Abuse (NIDA)
Conditions:
Drug Addiction
Nicotine Dependence
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
Background: * Smoking is the leading cause of preventable death in the United States, and researchers are interested in gaining a better understanding of the perceived beneficial effects of nicotine ...
Detailed Description
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-fe...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- 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
- NicAlert reading greater than or equal to 3
- EXCLUSION CRITERIA:
- definite plan to quit smoking in next 30 days
- consumption of more than 15 alcoholic drinks per week during the past month
- 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
- untreated cardiovascular or pulmonary disease
- use of nicotine replacement products, bupropion or varenicline, in the past 3 months if specifically used to stop smoking
- 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)
- SCL-90 \> 65 (must be evaluated by a counselor)
- Beck Depression Inventory-II score greater than or equal to 14 (must be evaluated by a counselor)
- vital signs (must be outside these parameters on more than two occasions separated by at least one day):
- systolic blood pressure: minimum 95, maximum 160 mm Hg
- diastolic blood pressure: minimum 40, maximum 95 mm Hg
- pulse: minimum 50, maximum 105 bpm
- respirations: minimum 8, maximum 24 breaths per minute
- nasal passages: no pathology that would preclude administration of nasal spray
- under the influence of a drug or alcohol at experimental sessions
Exclusion
Key Trial Info
Start Date :
January 21 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 13 2012
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT01136642
Start Date
January 21 2010
End Date
November 13 2012
Last Update
December 16 2019
Active Locations (1)
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1
National Institute on Drug Abuse, Biomedical Research Center (BRC)
Baltimore, Maryland, United States, 21224