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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified December 2005 by National Institute on Drug Abuse (NIDA). Recruitment status was Active, not recruiting

First Received on December 20, 2005. Last Updated on October 25, 2007 History of Changes

Sponsor:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00267657

Purpose

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.

Condition	Intervention	Phase
Amphetamine-Related Disorders	Drug: Reserpine	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Assessment of Interactions Between IV Methamphetamine and Reserpine

Resource links provided by NLM:

MedlinePlus related topics: Drug Reactions Methamphetamine

Drug Information available for: Reserpine Methamphetamine hydrochloride Amphetamine Methamphetamine

U.S. FDA Resources

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

Craving
Cardiovascular
Subjective symptoms/Mood Effects
CNS norepinephrine turnover

Estimated Enrollment:	30
Study Start Date:	January 2004
Estimated Study Completion Date:	November 2004

Detailed Description:

Eligibility

Ages Eligible for Study:	21 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Please contact site for more details

Exclusion Criteria:

Please contact site for more details

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00267657

Locations

United States, California
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

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00267657 History of Changes
Other Study ID Numbers:	NIDA-CPU-0006-1
Study First Received:	December 20, 2005
Last Updated:	October 25, 2007
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Amphetamine-Related Disorders
Substance-Related Disorders
Mental Disorders
Methamphetamine
Amphetamine
Reserpine
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Dopamine Uptake Inhibitors
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Antihypertensive Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on February 09, 2012