"The Evaluation of Stimulant Withdrawal" | NCT00442923

Studies
"The Evaluation of Stimulant Withdrawal"

NCT00442923

Sponsor

Aaron J. Janowsky

Status

Withdrawn

Last Update Posted

Jan 31, 2019Actual

Enrollment

0Actual

Phase

Phase 2

Conditions

Anxiety
Relapse
Substance Addiction

Interventions

Coreg

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
1P50DA018165	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

This study was withdrawn for lack of progress. No subjects were recruited.

Expanded Access Info

Start Date

Jul 1, 2007Estimated

Primary Completion Date

Jun 30, 2010Estimated

Completion Date

Jun 30, 2011Estimated

First Submitted Date

Mar 2, 2007

First Submission Date that Met QC Criteria

Mar 2, 2007

First Posted Date

Mar 5, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 29, 2019

Last Update Posted Date

Jan 31, 2019Actual

Name	Class
National Institute on Drug Abuse (NIDA)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Label	Type	Description	Intervention Names
CTRL	Placebo Comparator		Drug: Coreg
TREAT	Experimental		Drug: Coreg

Name	Type	Description	Arm Group Labels	Other Names
Coreg	Drug		CTRL TREAT

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

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

Facility	Status	City	State	ZIP	Country	Contacts
US Veterans Hospital		Portland	Oregon	97239	United States

Condition Browse Module

MeSH Terms

ID	Term
D001008	Anxiety Disorders
D012008	Recurrence
D019966	Substance-Related Disorders

Ancestor Terms

ID	Term
D001523	Mental Disorders
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077261	Carvedilol

Ancestor Terms

ID	Term
D011412	Propanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided