|
Role of Metabolites in Nicotine Dependence (4) - 13 Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about Role of Metabolites in Nicotine Dependence (4) - 13 conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Role of Metabolites in Nicotine Dependence (4) - 13 Clinical research trials and Role of Metabolites in Nicotine Dependence (4) - 13 health trials occur in a lot of of places throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as Role of Metabolites in Nicotine Dependence (4) - 13. Role of Metabolites in Nicotine Dependence (4) - 13 Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a Role of Metabolites in Nicotine Dependence (4) - 13 clinical trial. Human subjects frequently get the finest healthcare available for their Role of Metabolites in Nicotine Dependence (4) - 13 condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "R" Clinical Trials Conditions > Role of Metabolites in Nicotine Dependence (4) - 13  Role of Metabolites in Nicotine Dependence (4) - 13
Role of Metabolites in Nicotine Dependence (4) - 13
For Condition: Tobacco Use Disorder
Status: Completed
Sponsor(s): National Institute on Drug Abuse (NIDA) , University of Minnesota
Synopsis: To determine the effects of continine with or without a transdermal nicotine replacement on tobacco withdrawal symptoms.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Double-Blind, Placebo Control, Crossover Assignment
Minimum Age/Maximum Age: 21 Years/45 Years
Genders: Both
Protocol Entry Criteria: 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 ps ychiatric illness;less than 1 year since last episode of major depressive episode.
Total Enrollment: 0
Location and Contact Information:
Overall Study Official:
DorothyHatsukami, Principal Investigator, University of Minnesota
University of Minnesota
Minneapolis, Minnesota, 55455
United States
Additional Information:
Study ID Numbers: NIDA-09259-13; P50-09259-13
Study Start Date: November 1997
Record last reviewed: February 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000296
Other Tobacco Use Disorder Studies:
1. Incentive Programs for Female Substance Abusers Who Smoke - 3
2. Smoking Cessation Treatment with Transdermal Nicotine Replacement Therapy - 1
3. Maintenance treatment for Prevention of Smoking Relapse - 1
4. Role of Metabolites in Nicotine Dependence (1) - 1
5. Combining a Smoke Ending Aid with Behavioral Treatment - 1
Related Studies:
Other Tobacco Use Disorder Clinical Trials
Other Minnesota Clinical Trials
Other Minneapolis Clinical Trials
Role of Metabolites in Nicotine Dependence (4) - 13
|
|
|
|
|
|
|
|
