Clinical Trials Directory

Trials / Completed

CompletedNCT00000289

Role of Metabolites in Nicotine Dependence (3) - 6

Role of Metabolites in Nicotine Dependence (3)

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 various doses of ondansetron transdermal nicotine replacement on tobacco withdrawal symptoms.

Detailed description

Previous studies have shown that cotinine, a metabolite of nicotine, antagonizes the beneficial effects of the nicotine patch in redugin withdrawal symptoms. Studies have also shown that cotinine enhances serotonin levels. This study examined the effects of several doses of a 5HT3 antagonist, ondanstron, in combination with the nicotine patch. This medication has been observed to reduce nicotine withdrawal symptoms in rats. These effects were compared to the nicotine patch alone. The results of this study produced some modest effects showing that the 8mg dose of ondansetron suppressed tobacco withdrawal symptoms to a greater extent than the nicotine patch alone.

Conditions

Interventions

TypeNameDescription
DRUGOndansetron

Timeline

Start date
1998-05-01
Completion
2001-12-01
First posted
1999-09-21
Last updated
2017-01-12

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00000289. Inclusion in this directory is not an endorsement.

Role of Metabolites in Nicotine Dependence (3) - 6 (NCT00000289) · Clinical Trials Directory