"The Evaluation of Stimulant Withdrawal"

NCT ID: NCT00442923

Last Updated: 2019-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-01

Study Completion Date

2011-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Anxiety Relapse Substance Addiction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Study Groups

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CTRL

Group Type PLACEBO_COMPARATOR

Coreg

Intervention Type DRUG

TREAT

Group Type EXPERIMENTAL

Coreg

Intervention Type DRUG

Interventions

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Coreg

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Aaron J. Janowsky

OTHER

Sponsor Role lead

Responsible Party

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Aaron J. Janowsky

Director, Methamphetamine Abuse Research Center

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Paul S Berger, M.D.

Role: PRINCIPAL_INVESTIGATOR

OHSU/ US VA

Locations

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US Veterans Hospital

Portland, Oregon, United States

Site Status

Countries

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United States

Other Identifiers

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1P50DA018165

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1P50DA018165

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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