NCT00000296

Role of Metabolites in Nicotine Dependence (4) - 13

Role of Metabolites in Nicotine Dependence (4)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (planned)
• Sponsor: National Institute on Drug Abuse (NIDA) · NIH
• Sex: All
• Age: 21 Years – 45 Years
• Healthy volunteers: Not accepted

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

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.

Conditions

• Tobacco Use Disorder

Interventions

Type	Name	Description
DRUG	Cotinine fumarate

Timeline

• Start date: 1997-11-01
• Completion: 2001-12-01
• First posted: 1999-09-21
• Last updated: 2017-01-12

Locations

1 site across 1 country: United States