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 - Tabular View

Tracking Information

First Received Date ^ICMJE

December 20, 2005

Last Updated Date

October 25, 2007

Start Date ^ICMJE

January 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Craving
Cardiovascular
Subjective symptoms/Mood Effects
CNS norepinephrine turnover

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00267657 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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 ^ICMJE

Assessment of Interactions Between IV Methamphetamine and Reserpine

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

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study

Condition ^ICMJE

Amphetamine-Related Disorders

Intervention ^ICMJE

Drug: Reserpine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

November 2004

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Please contact site for more details

Exclusion Criteria:

Please contact site for more details

Gender

Both

Ages

21 Years to 45 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00267657

Responsible Party

Study ID Numbers ^ICMJE

NIDA-CPU-0006-1

Study Sponsor ^ICMJE

National Institute on Drug Abuse (NIDA)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Reese Jones, M.D.

Langley Porter Psychiatric Institute

Information Provided By

National Institute on Drug Abuse (NIDA)

Verification Date

December 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP