"The Evaluation of Stimulant Withdrawal"

Verified by: National Institute on Drug Abuse (NIDA), December 2007
First Received: March 2, 2007 | Last Updated: December 3, 2007 | Phase: Phase 2 | Start Date: 
Overall Status: Withdrawn | Estimated Enrollment: 80
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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...

Brief Summary

Official Title: “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 Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind

Intervention(s) in this Clinical Trial

  • Drug: Coreg

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Clinical Trial Investigator Information

Lead Investigator: National Institute on Drug Abuse (NIDA) NIH

Overall Clinical Trial Officials and Contacts

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

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00442923

Study ID Number: 1P50 DA018165

ClinicalTrials.gov Identifier: NCT00442923

Health Authority: United States: Federal Government

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