"The Evaluation of Stimulant Withdrawal" - Full Text View

"The Evaluation of Stimulant Withdrawal" (MARC)

This study has been withdrawn prior to enrollment.

( This study was withdrawn for lack of progress.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

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

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind
Official Title:	Scientific Component IV: Pharmacotherapy to Prevent Methamphetamine Relapse

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Methamphetamine

Drug Information available for: Methamphetamine hydrochloride Carvedilol Amphetamine Methamphetamine

U.S. FDA Resources

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

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

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

Methamphetamine
Coreg
Withdrawal
anxiety
Substance Addiction

Additional relevant MeSH terms:

Anxiety Disorders
Recurrence
Substance-Related Disorders
Behavior, Addictive
Mental Disorders
Disease Attributes
Pathologic Processes
Compulsive Behavior
Impulsive Behavior
Methamphetamine
Amphetamine
Carvedilol
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
Adrenergic beta-Antagonists
Adrenergic Antagonists
Antihypertensive Agents

ClinicalTrials.gov processed this record on February 09, 2012