Trial intelligence / Profile preview

Ondansetron and Nicotine Patch for Tobacco Withdrawal

NCT00000289Phase 2

Key facts

Status
Completed
Start
May 1998
Countries
1
Sponsor
National Institute on Drug Abuse
Modality
Small Molecules
Conditions
Tobacco Use Disorder (TUD)
01

Overview

Phase 2 trial of ondansetron in Tobacco Use Disorder (TUD) (2 arms), sponsored by National Institute on Drug Abuse. Primary endpoints: Subjective effects, Physiological effects and 1 more. Started May 1998; status: completed.

02

Design

2 arms
  • Ondansetron + Nicotine Patch

    Subjects receive various doses of ondansetron in combination with the nicotine patch.

  • Nicotine Patch Alone

    Subjects receive the nicotine patch alone as an active control.

03

Who it enrols

Male/Female subjects ages 21-45 years inclusive, with a smoking history of at least 15 cigarettes daily for at least 1 yr, in good health, motivated to stop smoking, and having experienced at least 4 withdrawal symptoms upon abstinence.

04

Endpoints

Primary

  • Subjective effects

  • Physiological effects

  • Performance effects

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