Back to results"The Evaluation of Stimulant Withdrawal" (MARC)
Primary Purpose
Anxiety, Relapse, Substance Addiction
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Coreg
Sponsored by
About this trial
This is an interventional basic science trial for Anxiety focused on measuring Methamphetamine, Coreg, Withdrawal, anxiety, Substance Addiction
Eligibility 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
Sites / Locations
- US Veterans Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
CTRL
TREAT
Arm Description
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00442923
First Posted
March 2, 2007
Last Updated
January 29, 2019
Sponsor
Aaron J. Janowsky
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00442923
Brief Title
"The Evaluation of Stimulant Withdrawal"
Acronym
MARC
Official Title
Scientific Component IV: Pharmacotherapy to Prevent Methamphetamine Relapse
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Withdrawn
Why Stopped
This study was withdrawn for lack of progress. No subjects were recruited.
Study Start Date
July 1, 2007 (Anticipated)
Primary Completion Date
June 30, 2010 (Anticipated)
Study Completion Date
June 30, 2011 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Aaron J. Janowsky
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Relapse, Substance Addiction
Keywords
Methamphetamine, Coreg, Withdrawal, anxiety, Substance Addiction
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CTRL
Arm Type
Placebo Comparator
Arm Title
TREAT
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Coreg
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul S Berger, M.D.
Organizational Affiliation
OHSU/ US VA
Official's Role
Principal Investigator
Facility Information:
Facility Name
US Veterans Hospital
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
12. IPD Sharing Statement
Learn more about this trial
"The Evaluation of Stimulant Withdrawal"
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