Cocaine DependencePhase 2NCT01171183
Carvedilol for Psychostimulant Dependence
A Phase 2 study of Cocaine Dependence and Cocaine Withdrawal, run by University of Arkansas at 1 site in United States.
Trial summary
This study examines whether carvedilol prolongs abstinence in recently abstinent cocaine dependent participants. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Cocaine Dependence, Cocaine Withdrawal
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to May 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-45 years old
- Cocaine dependence, as assessed by the substance abuse section of the Structured Clinical Interview for DSM-IV.
- At least weekly self-reported cocaine use during a preceding three month period
- Urine toxicology screen positive for cocaine or cocaine metabolite
- Women of childbearing age must have a negative pregnancy test, agree to adequate contraception to prevent pregnancy during the study, agree to monthly pregnancy testing and not be nursing
Who cannot join
- Suicide attempts within the past 12 months or suicidal ideations or psychotic symptoms in the past 6 months as determined by a study physician.
- Current opioid, alcohol or sedative physical dependence or amphetamine dependence.
- Major cardiovascular disorder that contraindicates study participation (e.g., history of myocardial infarction, stroke, congestive heart failure, cardiac arrhythmia, significant hypertension [i.e., >170 SBP or >110 DBP] or an unstable medical condition (e.g., untreated bacterial infection) as determined by the study physician.
- Asthma or chronic obstructive pulmonary disease.
- History of schizophrenia, or bipolar type I disorder.
- Use of medications that would be expected to have major interaction with carvedilol (e.g., rifampin, cimetidine, digoxin, diuretics).
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- Medical contraindication to receiving carvedilol (e.g., diabetes, severe bradycardia, bronchial asthma or other bronchospastic condition, 2nd or 3rd degree AV block, sick sinus rhythm, severe hepatic impairment, documented hypersensitivity to carvedilol).
- Patients currently taking selective serotonin re-uptake inhibitors, antipsychotics and antidepressants (e.g., amitriptyline and imipramine).
- Liver function tests (i.e., liver enzymes) greater than three times normal levels.
- Systolic blood pressure > 170 mmHg or < 90 mmHg, diastolic blood pressure > 110 mmHg or < 60 mmHg, or heart rate of > 110 beats/min or < 55 beats/min. Supine blood pressure of 100/65 mm Hg or lower, a seated blood pressure of 90/60 mm Hg or lower, or an orthostatic change of >20mm Hg systolic or 10 mm Hg diastolic on standing.
- Participants with estimated glomerular filtration rate < 30 ml/min.
- Pregnant or nursing female.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
Official title: Clinical Efficacy of Carvedilol for Psychostimulant Dependence
This study examines whether carvedilol prolongs abstinence in recently abstinent cocaine dependent participants.
- Conditions
- Cocaine Dependence, Cocaine Withdrawal
- Being tested
- controlled release carvedilol, Placebo
- Keywords
- cocaine dependence, cocaine withdrawal
- Medical subject headings
- Cocaine-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
controlled release carvedilolDrug
Also called Coreg CR
carvedilol (Coreg CR) 80 mg/day in once daily dosing for 12 weeks followed by a 2-week taper
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Carvedilol controlled release | Active comparator | controlled release carvedilol (Coreg CR) at 80 mg/day in once daily dosing Receives: Drug: controlled release carvedilol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine Toxicology Screens
Treatment Effectiveness Score, defined by the # of cocaine negative urines during the outpatient phase of the study divided by the total number of urine samples (30) and then multiplied by 100.
Measured: based on thrice weekly urine results during the 10-week outpatient phase
Secondary outcomes (1)
Retention
number of weeks each participant is on study protocol
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2010 (estimated)
- Study startAug 2010
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cocaine DependenceStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Baylor College of Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01171183
- Sponsor's protocol ID
- 2P50DA018197
- Other IDs
- 2P50DA018197
- Status last verified
- Jul 2015
- First submitted
- 27 Jul 2010
- Last updated
- 31 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Carvedilol for Psychostimulant Dependence
- ClinicalTrials.gov ID
- NCT01171183
- Acronym / sponsor ID
- 2P50DA018197
- Conditions
- Cocaine Dependence, Cocaine Withdrawal
- Keywords
- cocaine dependence, cocaine withdrawal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Baylor College of Medicine
- Study start
- Aug 2010
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 28 Jul 2010 (estimated)
- Results
- Posted 31 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study examines whether carvedilol prolongs abstinence in recently abstinent cocaine dependent participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Carvedilol controlled release | Active comparator | Drug: controlled release carvedilolcontrolled release carvedilol (Coreg CR) at 80 mg/day in once daily dosing |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 18-45 years old
- Cocaine dependence, as assessed by the substance abuse section of the Structured Clinical Interview for DSM-IV.
- At least weekly self-reported cocaine use during a preceding three month period
- Urine toxicology screen positive for cocaine or cocaine metabolite
- Women of childbearing age must have a negative pregnancy test, agree to adequate contraception to prevent pregnancy during the study, agree to monthly pregnancy testing and not be nursing
Key exclusion criteria (12 listed)
- Suicide attempts within the past 12 months or suicidal ideations or psychotic symptoms in the past 6 months as determined by a study physician.
- Current opioid, alcohol or sedative physical dependence or amphetamine dependence.
- Major cardiovascular disorder that contraindicates study participation (e.g., history of myocardial infarction, stroke, congestive heart failure, cardiac arrhythmia, significant hypertension [i.e., >170 SBP or >110 DBP] or an unstable medical condition (e.g., untreated bacterial infection) as determined by the study physician.
- Asthma or chronic obstructive pulmonary disease.
- History of schizophrenia, or bipolar type I disorder.
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 |
|---|---|---|
| controlled release carvedilolAlso: Coreg CRcarvedilol (Coreg CR) 80 mg/day in once daily dosing for 12 weeks followed by a 2-week taper | Drug | Carvedilol controlled release |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Urine Toxicology Screens
Time frame: based on thrice weekly urine results during the 10-week outpatient phase
Treatment Effectiveness Score, defined by the # of cocaine negative urines during the outpatient phase of the study divided by the total number of urine samples (30) and then multiplied by 100.
1 secondary outcome
Retention
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 of Cocaine Dependence and Cocaine Withdrawal, run by University of Arkansas 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 5 inclusion and 12 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: finished, as of the sponsor's last update on 31 Jul 2015. 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?
Yes. Results are posted in the registry (first posted 31 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
Urine Toxicology Screens (time frame: based on thrice weekly urine results during the 10-week outpatient phase). It is what the study was designed to measure, not a finding.
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 Jul 2015.