Role of Metabolites in Nicotine Dependence (1) - 1

NCT ID: NCT00000284

Last Updated: 2017-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 1995-02-28
• Study Completion Date: 2001-12-31

Brief Summary

The purpose of this study is to determine the effects of cotinine with or without a transdermal nicotine replacement on tobacco withdrawal symptoms.

Detailed Description

The purpose of this study was to determine the effects of a metabolite of nicotine, cotinine, on tobacco withdrawal symptoms. Cotinine has been shown to have psychoactive effects that are similar as well as different from those of nicotine, however, little research has been conducted examining the role cotinine plays in nicotine addiction. This study compared the effects of cotinine with the nicotine patch, and a combination thereof on tobacco withdrawal symptoms. The results showed that cotinine antagonizes the beneficial effects of the nicotine patch in reducing withdrawal symptoms.

Conditions

Tobacco Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Cotinine fumarate

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Male or female subjects, aged 21-45 yrs inclusive, with a smoking history of at least 1 pack of cigarettes daily for at least 1 year. Subject must be in good health as verified by medical history, screening exam, and screening laboratory tests. Subject must provide written informed consent to participate in the study and be motivated to stop smoking for a short term.

Exclusion Criteria

History of myocardial infarction, angina pectoris, sustained or episodic cardiac arrhythmias, symptomatic peripheral vascular disease, peptic ulcer disease or any other medical condition which the physician or investigator deems inappropriate for 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; chronic use of systemic steroids or antihistamines; skin sensitivity which would preclude use of a transdermal system; abuse of alcohol or any other recreational or prescription drug; use of any other tobacco products, including smokeless tobacco and nicotine products; previous use of transdermal nicotine system; inability to fulfill all scheduled visits and examination procedures throughout the study period.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: lead

Principal Investigators

Dorothy Hatsukami, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

References

presented at Society of Research on nicotine and tobacco Psychopharmacology 1998. Presented at Society of Research on Nicotine and Tobacco Psychopharmacology (in press)

Reference Type: BACKGROUND

Campos CM, Mehran R, Capodanno D, Owen R, Windecker S, Varenne O, Stone GW, Valgimigli M, Hajjar LA, Kalil Filho R, Oldroyd K, Morice MC, Urban P, Abizaid A. Risk Burden of Cancer in Patients Treated With Abbreviated Dual Antiplatelet Therapy After PCI: Analysis of Multicenter Controlled High-Bleeding Risk Trials. Circ Cardiovasc Interv. 2024 Apr;17(4):e013000. doi: 10.1161/CIRCINTERVENTIONS.122.013000. Epub 2024 Apr 16.

Reference Type: DERIVED

PMID: 38626080 (View on PubMed)

Other Identifiers

P50-09259-1

Identifier Type: -

Identifier Source: secondary_id

NIDA-09259-1

Identifier Type: -

Identifier Source: org_study_id