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Effects of Labetalol on Nicotine Administration in Humans - 14
This study has been completed.
Study NCT00000297   Information provided by National Institute on Drug Abuse (NIDA)
First Received: September 20, 1999   Last Updated: November 3, 2005   History of Changes

September 20, 1999
November 3, 2005
October 1998
 
  • Subjective
  • Physiologic measures
Same as current
Complete list of historical versions of study NCT00000297 on ClinicalTrials.gov Archive Site
 
 
 
Effects of Labetalol on Nicotine Administration in Humans - 14
Effects of Labetalol on Nicotine Administration in Humans

The purpose of this study is to investigate the effects of labetalol in response to intravenous nicotine

The purpose of this study is to determine whether labetalol, an alpha and beta adrenergic blocker, will block the subjective and physiological effects of intravenously administered nicotine in humans. A total of 12 subjects will participate in the double blind placebo controlled, outpatient study. Subjects will have 3 separate experimental sessions 3-9 days apart. On each of the experimental sessions, a single oral dose of low (100mg) or high dose of labetalol (200mg ), or placebo will be administered. Two hours after labetalol or placebo treatment, subjects will receive 15 variance grams nicotine base/kg intravenously. Several physiological endocrine and subjective measures will be obtained during the sessions. We propose that blockage of adrenergic receptors by labetalol will significantly block the physological and subjective effects of nicotine.

Phase II
Interventional
Treatment, Double-Blind, Placebo Control
Tobacco Use Disorder
Drug: Labetalol
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
0
December 2001
 

Inclusion Criteria:

Male/Female, aged 21-55 years with a smoking history of at least 1 pack of cigarettes daily for at least 1 year. In good health as verified by medical history, screening examination, and screening laboratory tests.

Exclusion Criteria:

History of heart disease, peripheral vascular disease, COPD, any other medical condition which physician investigator deems inappropriate for subject participation. Pregnant or lactating or not using adequate birth control methods. Use of regular psychotropic medication (antidepressants, antipsychotics, or anxiolytics and recent psychiatric history). Chronic use of systemic steroids or antihistamines. Abuse of alcohol or any other recreational or prescription drug. Regular use of any other tobacco products, including smokeless tobacco and nicotine products.

Both
21 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00000297
 
NIDA-09259-14, P50-09259-14
National Institute on Drug Abuse (NIDA)
University of Minnesota
Principal Investigator: Dorothy Hatsukami, Ph.D. University of Minnesota
National Institute on Drug Abuse (NIDA)
October 1998

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP