Back to resultsCarvedilol for Psychostimulant Dependence
Primary Purpose
Cocaine Dependence, Cocaine Withdrawal
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
controlled release carvedilol
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Cocaine Dependence focused on measuring cocaine dependence, cocaine withdrawal
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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).
- 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.
Sites / Locations
- University of Arkansas for Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo
Carvedilol controlled release
Arm Description
controlled release carvedilol (Coreg CR) at 80 mg/day in once daily dosing
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Retention
number of weeks each participant is on study protocol
Full Information
NCT ID
NCT01171183
First Posted
July 27, 2010
Last Updated
July 29, 2015
Sponsor
University of Arkansas
Collaborators
National Institute on Drug Abuse (NIDA), Baylor College of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT01171183
Brief Title
Carvedilol for Psychostimulant Dependence
Official Title
Clinical Efficacy of Carvedilol for Psychostimulant Dependence
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas
Collaborators
National Institute on Drug Abuse (NIDA), Baylor College of Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study examines whether carvedilol prolongs abstinence in recently abstinent cocaine dependent participants.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Dependence, Cocaine Withdrawal
Keywords
cocaine dependence, cocaine withdrawal
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Carvedilol controlled release
Arm Type
Active Comparator
Arm Description
controlled release carvedilol (Coreg CR) at 80 mg/day in once daily dosing
Intervention Type
Drug
Intervention Name(s)
controlled release carvedilol
Other Intervention Name(s)
Coreg CR
Intervention Description
carvedilol (Coreg CR) 80 mg/day in once daily dosing for 12 weeks followed by a 2-week taper
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Urine Toxicology Screens
Description
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.
Time Frame
based on thrice weekly urine results during the 10-week outpatient phase
Secondary Outcome Measure Information:
Title
Retention
Description
number of weeks each participant is on study protocol
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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).
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.
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
12. IPD Sharing Statement
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Carvedilol for Psychostimulant Dependence
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