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NIDA-CTO-0011

Division

DTMC

HEAL Study

Investigator(s)

Bankole Johnson, DSc., M.D., Ph.D.

Title

Double-Blind, Placebo-Controlled, Dose Response Trial Of Ondansetron For The Treatment Of Methamphetamine Dependence

Short Description

This study was designed to be a preliminary assessment of the efficacy and safety of 3-wide range doses of ondansetron (0.25, 1.0 and 4.0 mg taken orally twice per day) to reduce methamphetamine use in subjects with methamphetamine dependence and to determine the optimal dose of ondansetron.

Release Date

Jan 15, 2019

Description

The primary objective of this study is to conduct a preliminary assessment of the possible efficacy of ondansetron to reduce methamphetamine use in outpatients with methamphetamine dependence. The hypothesis is that ondansetron treatment compared to placebo will decrease the weekly proportion of methamphetamine positive urines. The results of this study will be used to design subsequent larger studies to confirm the efficacy of ondansetron. This study is also intended to gather preliminary information on biological or psychosocial characteristics of patients who may show better ondansetron treatment responsiveness.

Keywords

Assessments

Addiction Severity Index Lite

Brief Substance Craving Scale

Clinical Global Impression Scales

Hamilton – Depression Rating Scale

Methamphetamine Withdrawal Questionnaire

Stroop Color Word Task