Carvedilol for Psychostimulant Dependence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01171183
Recruitment Status : Completed
First Posted : July 28, 2010
Results First Posted : July 31, 2015
Last Update Posted : July 31, 2015
National Institute on Drug Abuse (NIDA)
Baylor College of Medicine
Information provided by (Responsible Party):
University of Arkansas

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

Condition or disease Intervention/treatment Phase
Cocaine Dependence Cocaine Withdrawal Drug: controlled release carvedilol Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Efficacy of Carvedilol for Psychostimulant Dependence
Study Start Date : August 2010
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: 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

Primary Outcome Measures :
  1. Urine Toxicology Screens [ Time Frame: based on thrice weekly urine results during the 10-week outpatient phase ]
    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 :
  1. Retention [ Time Frame: 12 weeks ]
    number of weeks each participant is on study protocol

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01171183

United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
National Institute on Drug Abuse (NIDA)
Baylor College of Medicine

Responsible Party: University of Arkansas Identifier: NCT01171183     History of Changes
Other Study ID Numbers: 2P50DA018197 ( U.S. NIH Grant/Contract )
2P50DA018197 ( U.S. NIH Grant/Contract )
First Posted: July 28, 2010    Key Record Dates
Results First Posted: July 31, 2015
Last Update Posted: July 31, 2015
Last Verified: July 2015

Keywords provided by University of Arkansas:
cocaine dependence
cocaine withdrawal

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antihypertensive Agents
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists