Role of Metabolites in Nicotine Dependence (3) - 6
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00000289 |
Recruitment Status :
Completed
First Posted : September 21, 1999
Last Update Posted : January 12, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Tobacco Use Disorder | Drug: Ondansetron | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 0 participants |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | Role of Metabolites in Nicotine Dependence (3) |
Study Start Date : | May 1998 |
Study Completion Date : | December 2001 |

- Subjective effects
- Physiological effects
- Performance effects

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Ages Eligible for Study: | 21 Years to 45 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000289
United States, Minnesota | |
University of Minnesota | |
Minneapolis, Minnesota, United States, 55455 |
Principal Investigator: | Dorothy Hatsukami, Ph.D. | University of Minnesota |
ClinicalTrials.gov Identifier: | NCT00000289 |
Other Study ID Numbers: |
NIDA-09259-6 P50-09259-6 |
First Posted: | September 21, 1999 Key Record Dates |
Last Update Posted: | January 12, 2017 |
Last Verified: | December 1998 |
Tobacco Use Disorder Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Ondansetron Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Antipruritics |
Dermatologic Agents Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Anti-Anxiety Agents |