Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
National Institute on Drug Abuse (NIDA) University of Minnesota |
---|---|
Information provided by: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00000296 |
The purpose of this study is to determine the effects of cotinine with or without a transdermal nicotine replacement on tobacco withdrawal symptoms.
Condition | Intervention | Phase |
---|---|---|
Tobacco Use Disorder |
Drug: Cotinine fumarate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Double-Blind, Placebo Control, Crossover Assignment |
Official Title: | Role of Metabolites in Nicotine Dependence (4) |
Estimated Enrollment: | 0 |
Study Start Date: | November 1997 |
Estimated Study Completion Date: | December 2001 |
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 replicate and extend these findings and examine the effects of various doses of cotinine base compared placebo on withdrawal symptom as well as drug preference among abstinent smokers while using the nicotine patch. We hypothesized that cotinine will reduce the beneficial effects of the nicotine patch in reducing withdrawal symptoms and that placebo will be preferred over cotinine during the forced drug choice period.
Ages Eligible for Study: | 21 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Male/Female subjects, aged 21-45 years inclusive, with a smoking history of at least 20 cigarettes daily (greater than or equal to 50) for at lease 1 year. 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 recreation aor prescription drug (more tha 3 drinks per day or 21 drinks per week). 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 1 year since last episode of major depressive episode.
United States, Minnesota | |
University of Minnesota | |
Minneapolis, Minnesota, United States, 55455 |
Principal Investigator: | Dorothy Hatsukami, Ph.D. | University of Minnesota |
Study ID Numbers: | NIDA-09259-13, P50-09259-13 |
Study First Received: | September 20, 1999 |
Last Updated: | November 3, 2005 |
ClinicalTrials.gov Identifier: | NCT00000296 |
Health Authority: | United States: Federal Government |
Nicotine polacrilex Nicotine Mental Disorders |
Tobacco Use Disorder Substance-Related Disorders Disorders of Environmental Origin |