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NCT00000297 Clinical Trial

Effects of Labetalol on Nicotine Administration in Humans - 14

Tobacco Use Disorder Clinical Trial

Official title:
Effects of Labetalol on Nicotine Administration in Humans

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00000297
Other study ID # NIDA-09259-14
Secondary ID P50-09259-14
Status Completed
Phase Phase 2
First received September 20, 1999
Last updated January 11, 2017
Start date October 1998
Est. completion date December 2001

Study information
Verified date October 1998
Source National Institute on Drug Abuse (NIDA)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date December 2001
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 21 Years to 55 Years
Eligibility 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.

Study Design

Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Labetalol

Locations
Country Name City State
United States University of Minnesota Minneapolis Minnesota

Sponsors (2)
Lead Sponsor Collaborator
National Institute on Drug Abuse (NIDA) University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Subjective
Primary Physiologic measures
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