Carvedilol for Psychostimulant Dependence
This study is currently recruiting participants.
Verified May 2012 by University of Arkansas
Sponsor:
University of Arkansas
Collaborators:
Baylor College of Medicine
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT01171183
First received: July 27, 2010
Last updated: May 8, 2012
Last verified: May 2012
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Purpose
This study examines whether carvedilol prolongs abstinence in recently abstinent cocaine dependent participants.
| Condition | Intervention | Phase |
|---|---|---|
|
Cocaine Dependence Cocaine Withdrawal |
Drug: controlled release carvedilol Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Clinical Efficacy of Carvedilol for Psychostimulant Dependence |
Resource links provided by NLM:
Further study details as provided by University of Arkansas:
Primary Outcome Measures:
- urine toxicology screens [ Time Frame: thrice weekly for 12 weeks ] [ Designated as safety issue: No ]cocaine use, as measured by thrice-weekly urine toxicology screens
Secondary Outcome Measures:
- retention [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]number of weeks each participant is on study protocol
- withdrawal symptoms [ Time Frame: thrice weekly during weeks 1 and 2 ] [ Designated as safety issue: No ]
- orthostatic blood pressure [ Time Frame: thrice weekly for 15 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 75 |
| Study Start Date: | August 2010 |
| Estimated Study Completion Date: | July 2014 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Placebo |
Drug: Placebo
Placebo
|
|
Active Comparator: Carvedilol controlled release
controlled release carvedilol (Coreg CR) at 80 mg/day in once daily dosing
|
Drug: controlled release carvedilol
carvedilol (Coreg CR) 80 mg/day in once daily dosing for 12 weeks followed by a 2-week taper
Other Name: Coreg CR
|
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01171183
Contacts
| Contact: Srinivasa Gokarakonda | 501-526-7969 | SBGokarakonda@uams.edu |
Locations
| United States, Arkansas | |
| University of Arkansas for Medical Sciences | Recruiting |
| Little Rock, Arkansas, United States, 72205 | |
| Contact: Favrin Smith 501-526-8423 smithfavrinm@uams.edu | |
| Principal Investigator: Alison Oliveto, Ph.D. | |
| Sub-Investigator: Michael Mancino, M.D. | |
Sponsors and Collaborators
University of Arkansas
Baylor College of Medicine
More Information
No publications provided
| Responsible Party: | University of Arkansas |
| ClinicalTrials.gov Identifier: | NCT01171183 History of Changes |
| Other Study ID Numbers: | 2 P50 DA018197, 2P50DA018197 |
| Study First Received: | July 27, 2010 |
| Last Updated: | May 8, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Arkansas:
|
cocaine dependence cocaine withdrawal |
Additional relevant MeSH terms:
|
Substance Withdrawal Syndrome Cocaine-Related Disorders Substance-Related Disorders Mental Disorders Carvedilol Central Nervous System Stimulants Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Vasodilator Agents Adrenergic alpha-1 Receptor Antagonists Adrenergic alpha-Antagonists Central Nervous System Agents |
ClinicalTrials.gov processed this record on October 17, 2012
