Role of Metabolites in Nicotine Dependence (4) - 13
Completed · Phase 2
Conditions studied: Tobacco Use Disorder
In brief
The purpose of this study is to determine the effects of cotinine with or without a transdermal nicotine replacement on tobacco withdrawal symptoms.
Key facts
- Study ID
- NCT00000296
- Run by
- National Institute on Drug Abuse (NIDA)
- People needed
- 0
- Starts
- 1997-11-01
- Expected to finish
- 2001-12-01
- Last updated by the study team
- 2017-01-12
Who can join
Age: 21 and older, up to 45. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- University of Minnesota — Minneapolis, Minnesota, United States
Full record on ClinicalTrials.gov
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