AnxietyPhase 2MARCNCT00442923
"The Evaluation of Stimulant Withdrawal"
A Phase 2 study testing Coreg in people with Anxiety and Relapse, run by Aaron J. Janowsky at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Relapse, Substance Addiction
- What is being tested?
- Coreg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2007to 30 Jun 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Anxiety, Relapse, Substance Addiction
- Being tested
- Coreg
- Keywords
- Methamphetamine, Coreg, Withdrawal, anxiety, Substance Addiction
- Medical subject headings
- Anxiety Disorders, Recurrence, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoregDrug
| Study group | Role | What they receive |
|---|---|---|
| CTRL | Placebo comparator | Not described Receives: Drug: Coreg |
| TREAT | Experimental | Not described Receives: Drug: Coreg |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2007 (estimated)
- Study start1 Jul 2007 (estimated)
- Primary completion30 Jun 2010 (estimated)
- Study completion30 Jun 2011 (estimated)
Why it stopped: This study was withdrawn for lack of progress. No subjects were recruited.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aaron J. Janowsky
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor-investigator, Aaron J. Janowsky, Oregon Health and Science University
- Investigators
- Paul S Berger, M.D., Principal investigator, OHSU/ US VA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00442923
- Sponsor's protocol ID
- 1P50DA018165
- Other IDs
- 1P50DA018165
- Acronym
- MARC
- Status last verified
- Jan 2019
- First submitted
- 2 Mar 2007
- Last updated
- 31 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scientific Component IV: Pharmacotherapy to Prevent Methamphetamine Relapse
- ClinicalTrials.gov ID
- NCT00442923
- Acronym / sponsor ID
- MARC / 1P50DA018165
- Conditions
- Anxiety, Relapse, Substance Addiction
- Keywords
- Methamphetamine, Coreg, Withdrawal, anxiety, Substance Addiction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study was withdrawn for lack of progress. No subjects were recruited.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Aaron J. JanowskyUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Jul 2007 (estimated)
- Primary completion
- 30 Jun 2010 (estimated)
- Study completion
- 30 Jun 2011 (estimated)
- First posted
- 5 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CTRL | Placebo comparator | Drug: Coreg |
| TREAT | Experimental | Drug: Coreg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coreg | Drug | CTRL, TREAT |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul S Berger, M.D. principal investigator
OHSU/ US VA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Coreg in people with Anxiety and Relapse, run by Aaron J. Janowsky at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 31 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2019.