Clinical trial NCT01171183: Carvedilol for Psychostimulant Dependence
Official title: Clinical Efficacy of Carvedilol for Psychostimulant Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cocaine Dependence
Cocaine Withdrawal
Keywords: cocaine dependence
cocaine withdrawal
Lead sponsor: University of Arkansas
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Baylor College of Medicine
First posted: 2010-07-28
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study examines whether carvedilol prolongs abstinence in recently abstinent cocaine dependent participants.


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.

Primary outcomes:
measure: Urine Toxicology Screens
timeFrame: based on thrice weekly urine results during the 10-week outpatient phase
Secondary outcomes:
measure: Retention
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
References: