"The Evaluation of Stimulant Withdrawal"

NCT00442923 | Withdrawn Phase 2 DMC

• 1 other identifier: 1P50DA018165
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anxiety; Relapse; Substance Addiction

Keywords

Methamphetamine; Coreg; Withdrawal; anxiety; Substance Addiction

Study Arms (2)

CTRL

PLACEBO COMPARATOR

Drug: Coreg

TREAT

EXPERIMENTAL

Drug: Coreg

Interventions

Coreg DRUG

CTRL; TREAT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aaron J. Janowsky: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

US Veterans Hospital

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Recurrence; Substance-Related Disorders

Interventions

Carvedilol

Condition Hierarchy (Ancestors)

Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring

Study Officials

• Paul S Berger, M.D.

  OHSU/ US VA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Methamphetamine Abuse Research Center

Study Record Dates

• First Submitted: March 2, 2007
• First Posted: March 5, 2007
• Study Start: July 1, 2007
• Primary Completion: June 30, 2010
• Study Completion: June 30, 2011
• Last Updated: January 31, 2019

Record last verified: 2019-01

Locations

US (1)