"The Evaluation of Stimulant Withdrawal" (MARC)

January 29, 2019 updated by: Aaron J. Janowsky

Scientific Component IV: Pharmacotherapy to Prevent Methamphetamine Relapse

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: CTRL
Drug: Coreg
Experimental: TREAT
Drug: Coreg

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aaron J. Janowsky

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Paul S Berger, M.D., OHSU/ US VA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2007

Primary Completion (Anticipated)

June 30, 2010

Study Completion (Anticipated)

June 30, 2011

Study Registration Dates

First Submitted

March 2, 2007

First Submitted That Met QC Criteria

March 2, 2007

First Posted (Estimate)

March 5, 2007

Study Record Updates

Last Update Posted (Actual)

January 31, 2019

Last Update Submitted That Met QC Criteria

January 29, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1P50DA018165 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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