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| ID | Type | Description | Link |
|---|---|---|---|
| 2P50DA018197 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| Baylor College of Medicine | OTHER |
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This study examines whether carvedilol prolongs abstinence in recently abstinent cocaine dependent participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Carvedilol controlled release | Active Comparator | controlled release carvedilol (Coreg CR) at 80 mg/day in once daily dosing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| controlled release carvedilol | Drug | carvedilol (Coreg CR) 80 mg/day in once daily dosing for 12 weeks followed by a 2-week taper |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | based on thrice weekly urine results during the 10-week outpatient phase |
| Measure | Description | Time Frame |
|---|---|---|
| Retention | number of weeks each participant is on study protocol | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo: Placebo |
| FG001 | Carvedilol Controlled Release | controlled release carvedilol (Coreg CR) at 80 mg/day in once daily dosing controlled release carvedilol: carvedilol (Coreg CR) 80 mg/day in once daily dosing for 12 weeks followed by a 2-week taper |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Residential Facility (Weeks 1-2) |
|
| |||||||||||||||||||||
| Outpatient Participation (Weeks 3-10) |
|
Those who were admitted to the residential unit and received at least one dose of medication. The data for one person in the carvedilol arm was excluded from analyses as the person did not meet inclusion criteria for the study and was discharged by the third day.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo: Placebo |
| BG001 | Carvedilol Controlled Release | controlled release carvedilol (Coreg CR) at 80 mg/day in once daily dosing controlled release carvedilol: carvedilol (Coreg CR) 80 mg/day in once daily dosing for 12 weeks followed by a 2-week taper |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Those who completed the residential facility and attended at least one outpatient clinic visit to complete assessments. | Posted | Mean | Standard Deviation | percentage of cocaine negative urines | based on thrice weekly urine results during the 10-week outpatient phase |
|
during the 12 week trial as well as during the taper period
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo: Placebo |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Severe disabling hip pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Severe disabling hip pain that was later found to be cancer that that metastasized to the hip |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| lightheaded/dizzy | Vascular disorders | Systematic Assessment |
Small numbers of participants analyzed. Primary outcome measure based on successfully transition to outpatient phase of the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alison Oliveto, PhD | University of Arkansas for Medical Sciences | 501-526-8441 | olivetoalison@uams.edu |
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| ID | Term |
|---|---|
| D019970 | Cocaine-Related Disorders |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000077261 | Carvedilol |
| ID | Term |
|---|---|
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Placebo | Drug | Placebo |
|
| BP outside of study parameters |
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| NOT COMPLETED |
|
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
|
|
| Secondary | Retention | number of weeks each participant is on study protocol | Those eligible participants who entered the residential facility and received at least one dose of study medication. One person in the carvedilol group is excluded from all analyses due to not meeting inclusion criteria. | Posted | Mean | Standard Deviation | Weeks | 12 weeks |
|
|
|
|
| 0 |
| 15 |
| 8 |
| 15 |
| EG001 | Carvedilol Controlled Release | controlled release carvedilol (Coreg CR) at 80 mg/day in once daily dosing controlled release carvedilol: carvedilol (Coreg CR) 80 mg/day in once daily dosing for 12 weeks followed by a 2-week taper | 1 | 15 | 13 | 15 |
|
| dry mouth | Gastrointestinal disorders | Systematic Assessment |
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| sleep disturbances | Nervous system disorders | Systematic Assessment |
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| Bronchitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| vaginal yeast infection | Reproductive system and breast disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| cold hand, tingling fingers | Nervous system disorders | Systematic Assessment |
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| Penile discharge, burning | Renal and urinary disorders | Systematic Assessment |
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| Night Sweats | Renal and urinary disorders | Systematic Assessment |
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| cold symptoms | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | e.g., sore throat, swollen glands and congestion |
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| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| nausea/vomiting and/or diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| flu-like symptoms | Immune system disorders | Systematic Assessment | e.g., body aches, vomiting, low energy |
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| burned hand | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| swollen eye | Eye disorders | Systematic Assessment |
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| numbness in hand | Nervous system disorders | Systematic Assessment |
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| tiredness, lethargic | General disorders | Systematic Assessment |
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| Anxious, restless | Psychiatric disorders | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Fell down | General disorders | Systematic Assessment |
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| Sharp pain upper left torso | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Feeling "high" | Psychiatric disorders | Systematic Assessment |
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| Paranoid delusions | Psychiatric disorders | Systematic Assessment |
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| Frequent urination | Renal and urinary disorders | Systematic Assessment |
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| Insect bite | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Elevated blood pressure | Cardiac disorders | Systematic Assessment |
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| Hypotension | Cardiac disorders | Systematic Assessment |
|
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| D020005 |
| Propanols |
| D000588 | Amines |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D006575 | Heterocyclic Compounds, 3-Ring |