Back to resultsA Phase 1 Parallel-Group, Double-Blind, Placebo-Controlled Cardiovascular and Behavioral Study Assessing Interactions Between Single Doses of Oral Reserpine and Intravenous Methamphetamine - 1
Primary Purpose
Amphetamine-Related Disorders
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Reserpine
Sponsored by
About this trial
This is an interventional treatment trial for Amphetamine-Related Disorders
Eligibility Criteria
Inclusion Criteria: Please contact site for more details Exclusion Criteria: Please contact site for more details
Sites / Locations
- U of CA, San Francisco
Outcomes
Primary Outcome Measures
Craving
Cardiovascular
Subjective symptoms/Mood Effects
CNS norepinephrine turnover
Secondary Outcome Measures
Full Information
NCT ID
NCT00267657
First Posted
December 20, 2005
Last Updated
January 10, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00267657
Brief Title
A Phase 1 Parallel-Group, Double-Blind, Placebo-Controlled Cardiovascular and Behavioral Study Assessing Interactions Between Single Doses of Oral Reserpine and Intravenous Methamphetamine - 1
Official Title
Assessment of Interactions Between IV Methamphetamine and Reserpine
Study Type
Interventional
2. Study Status
Record Verification Date
December 2005
Overall Recruitment Status
Unknown status
Study Start Date
January 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute on Drug Abuse (NIDA)
4. Oversight
5. Study Description
Brief Summary
In this parallel group clinical pharmacology laboratory experiment, we will assess pharmacodynamic interactions (with a focus on cardiovascular effects) of a 15 mg intravenous methamphetamine dose and single oral doses of reserpine (0.5 and 1.0 mg) or placebo.
Detailed Description
In this parallel group clinical pharmacology laboratory experiment, we will assess pharmacodynamic interactions (with a focus on cardiovascular effects) of a 15 mg intravenous methamphetamine dose and single oral doses of reserpine (0.5 and 1.0 mg) or placebo.
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
30 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Reserpine
Primary Outcome Measure Information:
Title
Craving
Title
Cardiovascular
Title
Subjective symptoms/Mood Effects
Title
CNS norepinephrine turnover
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Please contact site for more details
Exclusion Criteria:
Please contact site for more 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
A Phase 1 Parallel-Group, Double-Blind, Placebo-Controlled Cardiovascular and Behavioral Study Assessing Interactions Between Single Doses of Oral Reserpine and Intravenous Methamphetamine - 1
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