"The Evaluation of Stimulant Withdrawal" - Full Text View

"The Evaluation of Stimulant Withdrawal" (MARC)

This study has been withdrawn prior to recruitment.

( This study was withdrawn for lack of progress. No subjects were recruited. )

First Received: March 2, 2007 Last Updated: December 3, 2007 History of Changes

Sponsored by:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00442923

Purpose

The purpose of this research study is to determine whether Carvedilol, an FDA approved beta blocker, when administered for an 8-week period to veterans currently undergoing treatment for methamphetamine dependence (1) improves their ability to stay in treatment longer, (2)eases the aversive symptoms that accompany stimulant withdrawal, and (3) increases the time they remain abstinent from methamphetamine.

Condition	Intervention	Phase
Anxiety Relapse Substance Addiction	Drug: Coreg	Phase II

MedlinePlus related topics: Anxiety Methamphetamine

Drug Information available for: Methamphetamine hydrochloride Carvedilol Amphetamine Methamphetamine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Scientific Component IV: Pharmacotherapy to Prevent Methamphetamine Relapse

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

Estimated Enrollment:

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Must have entered treatment into the outpatient Clinical Addiction Rehabilitation Section (CARS) through the US Portland Veterans Affairs Medical Center
Must meet the clinical definition for methamphetamine dependence
Self-reported methamphetamine use within 10 days of entering the study
Must be able to understand and sign the consent form

Exclusion Criteria:

Dependent on any other drug except nicotine, caffeine, marijuana and alcohol
Pregnant or nursing mothers
Psychosis
Dementia
Any serious medical condition that could be aggravated by the study protocol (Allergic reaction, Hypotension, Asthma, Bronchospastic conditions, Angina, Bronchitis, Emphysema, Bradycardia, Heart or blood vessel disease, Diabetes mellitus, Low blood sugar, Kidney disease, Liver disease or Overactive thyroid)
History of withdrawal seizures or delirium tremors
Use of MAO inhibitors within the last two weeks
Considerable hepatocellular injury, including cirrhosis of the liver or liver function test levels higher than 2 times normal

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00442923

Locations

United States, Oregon
US Veterans Hospital
Portland, Oregon, United States, 97239

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Paul S Berger, M.D.

OHSU/ US VA

More Information

No publications provided

Study ID Numbers:	1P50 DA018165
Study First Received:	March 2, 2007
Last Updated:	December 3, 2007
ClinicalTrials.gov Identifier:	NCT00442923 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Drug Abuse (NIDA):

Methamphetamine
Coreg
Withdrawal
anxiety
Substance Addiction

Study placed in the following topic categories:

Dopamine Uptake Inhibitors
Behavior, Addictive
Neurotransmitter Agents
Adrenergic Agents
Disorders of Environmental Origin
Central Nervous System Stimulants
Recurrence
Methamphetamine

Dopamine
Mental Disorders
Substance-Related Disorders
Amphetamine
Dopamine Agents
Peripheral Nervous System Agents
Carvedilol

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease Attributes
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Uptake Inhibitors
Sympathomimetics
Physiological Effects of Drugs
Disorders of Environmental Origin
Central Nervous System Stimulants

Recurrence
Pharmacologic Actions
Methamphetamine
Pathologic Processes
Mental Disorders
Autonomic Agents
Therapeutic Uses
Substance-Related Disorders
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009