"The Evaluation of Stimulant Withdrawal"
Information source: National Institute on Drug Abuse (NIDA)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Anxiety; Relapse; Substance Addiction
Intervention: Coreg (Drug)
Phase: Phase 2
Status: Withdrawn
Sponsored by: National Institute on Drug Abuse (NIDA) Official(s) and/or principal investigator(s):
Paul S Berger, M.D., Principal Investigator, Affiliation: OHSU/ US VA
Summary
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.
Clinical Details
Official title: Scientific Component IV: Pharmacotherapy to Prevent Methamphetamine Relapse
Study design: Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
US Veterans Hospital, Portland, Oregon 97239, United States
Additional Information
Last updated: December 3, 2007
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