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"The Evaluation of Stimulant Withdrawal" (MARC)

A

Aaron J. Janowsky

Status and phase

Withdrawn
Phase 2

Conditions

Substance Addiction
Relapse
Anxiety

Treatments

Drug: Coreg

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00442923
1P50DA018165 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

0 participants in 2 patient groups, including a placebo group

CTRL
Placebo Comparator group
Treatment:
Drug: Coreg
TREAT
Experimental group
Treatment:
Drug: Coreg

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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