Carvedilol for Psychostimulant Dependence

Clinical Efficacy of Carvedilol for Psychostimulant Dependence

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

Study Overview

• Status: Completed
• Conditions: Cocaine Dependence; Cocaine Withdrawal
• Intervention / Treatment: Drug: Placebo; Drug: controlled release carvedilol

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Coreg CR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retention	number of weeks each participant is on study protocol	12 weeks

Collaborators and Investigators

• Sponsor: University of Arkansas
• Collaborators: National Institute on Drug Abuse (NIDA); Baylor College of Medicine

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: July 27, 2010
• First Submitted That Met QC Criteria: July 27, 2010
• First Posted (Estimate): July 28, 2010

Study Record Updates

• Last Update Posted (Estimate): July 31, 2015
• Last Update Submitted That Met QC Criteria: July 29, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: cocaine dependence; cocaine withdrawal
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Cocaine-Related Disorders; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Protective Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Antioxidants; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Carvedilol
• Other Study ID Numbers: 2P50DA018197 (U.S. NIH Grant/Contract)