Role of Metabolites in Nicotine Dependence (2) - 5
Launched by NATIONAL INSTITUTE ON DRUG ABUSE (NIDA) · Sep 20, 1999
Trial Information
Current as of December 09, 2024
Completed
Keywords
ClinConnect Summary
Previous studies have shown that cotinine, a metabolite of nicotine, antagonizes some of the effects of nicotine. One study showed that nicotine eliminates some of the beneficial effects of the nicotine patch in reducing withdrawal symptoms. The purpose of this study was to examine the effects of cotinine. The results generally showed no effects on self-administration of cigarettes, although higher serum nicotine levels were observed on the highest doses of cotinine compared to placebo or lower doses of cotinine.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Male/Female subjects ages 21-45 yrs. inclusive, with a smoking history of at least 1 pack of cigarettes daily for at least 1 year. Subject must be in good health as verified by medical history, screening examination, and screening laboratory tests. Subject must provide written informed consent to participate in the study and be motivated to stop smoking for a short term.
- Exclusion Criteria:
- • History of myocardial infarction, angina pectoris, sustained or episodic cardiac arrhythmias, symptomatic peripheral vascular disease, peptic ulcer disease or any other medical condition which the physician or investigator deems inappropriate for participation. Insulin-dependent diabetes. Pregnant or lactating, or not using adequate birth control methods. Requirement of any form of regular psychotropic medication (antidepressants, antipsychotics, or anxiolytics) and recent psychiatric history). Chronic use of systemic steroids or antihistamines. Skin sensitivity which would preclude use of a transdermal system. Abuse of alcohol or any other recreational or prescription drug. Use of any other tobacco products including smokeless tobacco and nicotine products. Previous use of transdermal nicotine system. Inability to fulfill all scheduled visits and examination procedures throughout the study period.
Trial Officials
Dorothy Hatsukami, Ph.D.
Principal Investigator
University of Minnesota
About National Institute On Drug Abuse (Nida)
The National Institute on Drug Abuse (NIDA) is a leading federal agency within the U.S. Department of Health and Human Services, dedicated to advancing the understanding of drug abuse and addiction through rigorous scientific research. NIDA's mission encompasses the exploration of the biological, behavioral, and social aspects of substance use disorders, facilitating the development of effective prevention and treatment strategies. By funding and conducting innovative clinical trials, NIDA aims to translate research findings into practical solutions that improve public health and inform policy, ultimately contributing to the reduction of substance-related harm in communities across the nation.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Minneapolis, Minnesota, United States
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
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