Back to resultsOndansetron for the Treatment of Methamphetamine Dependence - 1
Primary Purpose
Amphetamine-Related Disorders
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ondansetron
Sponsored by
About this trial
This is an interventional treatment trial for Amphetamine-Related Disorders focused on measuring amphetamine dependence
Eligibility Criteria
Inclusion Criteria: 18 years of age. Treatment seeking for meth dependence. Exclusion Criteria: Please contact site director for more details.
Sites / Locations
- South Bay Treatment Center
- Matrix Institute on Addictions
- John A. Burns School of Medicine
- Powell Chemical Dependency Center
- University of Missouri - Kansas City
- University of Texas Health Science Center
Outcomes
Primary Outcome Measures
Clinicial improvement
Secondary Outcome Measures
Full Information
NCT ID
NCT00040053
First Posted
June 18, 2002
Last Updated
January 11, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
University of Texas
1. Study Identification
Unique Protocol Identification Number
NCT00040053
Brief Title
Ondansetron for the Treatment of Methamphetamine Dependence - 1
Official Title
Double-Blind, Placebo-Controlled, Dose Response Trial of Ondansetron for the Treatment of Methamphetamine Dependence.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
University of Texas
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amphetamine-Related Disorders
Keywords
amphetamine dependence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Masking
Double
Allocation
Randomized
Enrollment
154 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Ondansetron
Primary Outcome Measure Information:
Title
Clinicial improvement
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years of age. Treatment seeking for meth dependence.
Exclusion Criteria:
Please contact site director for more details.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Newton, M.D.
Organizational Affiliation
National Institute on Drug Abuse (NIDA)
Official's Role
Principal Investigator
Facility Information:
Facility Name
South Bay Treatment Center
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Facility Name
Matrix Institute on Addictions
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92627
Country
United States
Facility Name
John A. Burns School of Medicine
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Powell Chemical Dependency Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50316
Country
United States
Facility Name
University of Missouri - Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
University of Texas Health Science Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77225
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Ondansetron for the Treatment of Methamphetamine Dependence - 1
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