- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00442923
"The Evaluation of Stimulant Withdrawal" (MARC)
January 29, 2019 updated by: Aaron J. Janowsky
Scientific Component IV: Pharmacotherapy to Prevent Methamphetamine Relapse
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Oregon
-
Portland, Oregon, United States, 97239
- US Veterans Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: CTRL
|
|
Experimental: TREAT
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Paul S Berger, M.D., OHSU/ US VA
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
July 1, 2007
Primary Completion (Anticipated)
June 30, 2010
Study Completion (Anticipated)
June 30, 2011
Study Registration Dates
First Submitted
March 2, 2007
First Submitted That Met QC Criteria
March 2, 2007
First Posted (Estimate)
March 5, 2007
Study Record Updates
Last Update Posted (Actual)
January 31, 2019
Last Update Submitted That Met QC Criteria
January 29, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1P50DA018165 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anxiety
-
AstraZenecaCompletedAnxiety Disorders | Anxiety | Anxiety Neuroses | Anxiety StatesUnited States
-
Prisma Health-UpstateCompletedAnxiety | Anxiety, Separation | Separation Anxiety | Anxiety Generalized
-
Ann & Robert H Lurie Children's Hospital of ChicagoUniversity of California, Los Angeles; University of CincinnatiRecruitingAnxiety, Separation | Anxiety, Social | Anxiety, GeneralizedUnited States
-
Yale UniversityNational Institute of Mental Health (NIMH)Active, not recruitingGeneralized Anxiety Disorder | Anxiety Disorder of Childhood | Separation Anxiety Disorder of Childhood | Social Anxiety Disorder of ChildhoodUnited States
-
Nazife Begüm KARANCompletedDental Anxiety | Sedative; Anxiety DisorderTurkey
-
Eli Lilly and CompanyCompletedAnxiety Neuroses | Anxiety States, Neurotic | Neuroses, AnxietyUnited States, Mexico, South Africa
-
Loyola UniversityCompletedAnxiety | Anxiety State | Procedural AnxietyUnited States
-
West University of TimisoaraUnknownAnxiety Disorder/Anxiety StateRomania
-
Dr. Nazanin AlaviActive, not recruitingGeneralized Anxiety Disorder | AnxietyCanada
-
ProofPilotFisher WallaceActive, not recruitingGeneralized Anxiety Disorder | Anxiety | Generalized AnxietyUnited States
Clinical Trials on Coreg
-
CTI-1, LLCGlaxoSmithKline; CTI Clinical Trial and Consulting ServicesCompletedCongestive Heart FailureUnited States
-
Royan InstituteCompletedIn Vitro FertilizationIran, Islamic Republic of
-
Univar BVUnknownWilson DiseaseUnited Kingdom, Germany, Greece, Italy
-
West Virginia UniversityWest Virginia Clinical and Translational Science InstituteTerminatedGlioblastoma | Glioblastoma MultiformeUnited States
-
Virginia Commonwealth UniversityMedical University of South Carolina; Ochsner Health SystemWithdrawnDyspepsia | Gastroesophageal Reflux Disease | Non Erosive Reflux DiseaseUnited States
-
GlaxoSmithKlineCompletedHypertensionUnited States
-
University of MinnesotaGlaxoSmithKlineCompletedPre-hypertensionUnited States
-
GlaxoSmithKlineCompleted
-
West Virginia UniversityNovoCure Ltd.; West Virginia Clinical and Translational Science InstituteWithdrawnGlioblastoma | Glioblastoma MultiformeUnited States
-
Montefiore Medical CenterAlbert Einstein College of MedicineActive, not recruitingProstate CancerUnited States