Search / Trial NCT00000289

Role of Metabolites in Nicotine Dependence (3) - 6

Launched by NATIONAL INSTITUTE ON DRUG ABUSE (NIDA) · Sep 20, 1999

Trial Information

Current as of December 05, 2024

Completed

Keywords

ClinConnect Summary

Previous studies have shown that cotinine, a metabolite of nicotine, antagonizes the beneficial effects of the nicotine patch in redugin withdrawal symptoms. Studies have also shown that cotinine enhances serotonin levels. This study examined the effects of several doses of a 5HT3 antagonist, ondanstron, in combination with the nicotine patch. This medication has been observed to reduce nicotine withdrawal symptoms in rats. These effects were compared to the nicotine patch alone. The results of this study produced some modest effects showing that the 8mg dose of ondansetron suppressed tobac...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Male/Female subjects ages 21-45 years inclusive, with a smoking history of at least 15 cigarettes daily (greater than or equal to 50) for at least 1 yr. Subject is in good health as verified by medical history, screening examination, and screening laboratory tests as outlined above. Subject has provided written informed consent to participate in the study and is motivated to stop smoking. Subject has experienced at least 4 withdrawal symptoms upon abstinence.
  • Exclusion Criteria:
  • History of myocardial infarction, angina pectoris, sustained or episodic cardiac arrhythmias, symptomatic peripheral vascular disease, current peptic ulcer disease or any other medical condition which the physician investigator deems inappropriate for subject 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 (less than 1yr). Chronic use of systemic steroids or antihistamines. Abuse of alcohol or any other recreational or prescription drug (more than 3 drinks per day or 21 drinks per wk). use of any other nicotine products, including smokeless tobacco, cigars and nicotine replacement products. Inability to fulfill all scheduled visits and examination procedures throughout the study period. History of schizophrenia or manic depressive disorder. Recent history of other psychiatric illness (less than 1yr since last episode of major depressive episode).

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.

Locations

Minneapolis, Minnesota, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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