Back to resultsAssessment of Interactions Between Intravenous Methamphetamine and Modafinil - 1
Primary Purpose
Amphetamine-Related Disorders
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Modafinil
Sponsored by
About this trial
This is an interventional treatment trial for Amphetamine-Related Disorders
Eligibility Criteria
Inclusion Criteria: normotensive good physical and mental health body mass index between 18 and 30 if female, using an acceptable method of contraception and are not pregnant able to give voluntary informed consent Exclusion Criteria: Please contact site for further details
Sites / Locations
- U of CA, San Francisco
Outcomes
Primary Outcome Measures
Cardiovascular
Subjective symptoms/Mood Effects
Secondary Outcome Measures
Full Information
NCT ID
NCT00265278
First Posted
December 13, 2005
Last Updated
January 10, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00265278
Brief Title
Assessment of Interactions Between Intravenous Methamphetamine and Modafinil - 1
Official Title
Double-Blind, Placebo-Controlled Assessment of Interactions Between Intravenous Methamphetamine and Modafinil
Study Type
Interventional
2. Study Status
Record Verification Date
December 2005
Overall Recruitment Status
Unknown status
Study Start Date
March 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute on Drug Abuse (NIDA)
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to assess the potential interactions between intravenous methamphetamine and oral Modafinil.
Detailed Description
The primary aims of this experiment are to determine if there are significant safety interactions between oral modafinil and intravenous methamphetamine. Safety will be assessed by measuring adverse events and cardiovascular responses of heart rate (HR), blood pressure (BP), and electrocardiogram (ECG) and stroke distance (ICG).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amphetamine-Related Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
16 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Modafinil
Primary Outcome Measure Information:
Title
Cardiovascular
Title
Subjective symptoms/Mood Effects
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
normotensive
good physical and mental health
body mass index between 18 and 30
if female, using an acceptable method of contraception and are not pregnant
able to give voluntary informed consent
Exclusion Criteria:
Please contact site for further details
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reese Jones, M.D.
Organizational Affiliation
Langley Porter Psychiatric Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
U of CA, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Assessment of Interactions Between Intravenous Methamphetamine and Modafinil - 1
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