Assessment of Interactions Between Intravenous Methamphetamine and Modafinil - 1
Sponsor
National Institute on Drug Abuse (NIDA) (NIH)
Overall Status
Unknown status
CT.gov ID
NCT00265278
Collaborator
(none)
16
1
12
1.3
Study Details
Study Description
Brief Summary
The purpose of this study is to assess the potential interactions between intravenous methamphetamine and oral Modafinil.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
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).
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
Double-Blind, Placebo-Controlled Assessment of Interactions Between Intravenous Methamphetamine and Modafinil
Study Start Date
:
Mar 1, 2005
Study Completion Date
:
Mar 1, 2006
Outcome Measures
Primary Outcome Measures
- Cardiovascular []
- Subjective symptoms/Mood Effects []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | U of CA, San Francisco | San Francisco | California | United States | 94143 |
Sponsors and Collaborators
- National Institute on Drug Abuse (NIDA)
Investigators
- Principal Investigator: Reese Jones, M.D., Langley Porter Psychiatric Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00265278
Other Study ID Numbers:
- NIDA-CPU-0008-1
First Posted:
Dec 14, 2005
Last Update Posted:
Jan 11, 2017
Last Verified:
Dec 1, 2005