Ondansetron for the Treatment of Methamphetamine Dependen... | NCT00040053

Studies
Ondansetron for the Treatment of Methamphetamine Dependence - 1

NCT00040053

Sponsor

National Institute on Drug Abuse (NIDA)

Status

Completed

Last Update Posted

Jan 12, 2017Estimated

Enrollment

154

Phase

Phase 2

Conditions

Amphetamine-Related Disorders

Interventions

Ondansetron

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2002

Primary Completion Date

Not provided

Completion Date

Feb 2004Actual

First Submitted Date

Jun 18, 2002

First Submission Date that Met QC Criteria

Jun 17, 2002

First Posted Date

Jun 18, 2002Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 11, 2017

Last Update Posted Date

Jan 12, 2017Estimated

Name	Class
University of Texas	OTHER

Description Module

Brief Summary

The purpose of this study is to assess ondansetron for the treatment of methamphetamine dependence.

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

154

Name	Type	Description	Arm Group Labels	Other Names
Ondansetron	Drug

Measure	Description	Time Frame
Clinicial improvement

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years of age. Treatment seeking for meth dependence.

Exclusion Criteria:

Please contact site director for more details.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thomas Newton, M.D.	National Institute on Drug Abuse (NIDA)	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
South Bay Treatment Center		Chula Vista	California	91911	United States
Matrix Institute on Addictions

Condition Browse Module

MeSH Terms

ID	Term
D019969	Amphetamine-Related Disorders

Ancestor Terms

ID	Term
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017294	Ondansetron

Ancestor Terms

ID	Term
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided