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Completed

NCT Number: NCT01171183

Carvedilol for Psychostimulant Dependence

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

Completed

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

controlled release carvedilol

Drug

carvedilol (Coreg CR) 80 mg/day in once daily dosing for 12 weeks followed by a 2-week taper

Other names: Coreg CR

Placebo

Drug

Placebo

Primary outcomes

  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 outcomes

  1. Retention

    Time frame: 12 weeks

    number of weeks each participant is on study protocol

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Collaborators

  • Baylor College of Medicine
  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Clinical Efficacy of Carvedilol for Psychostimulant Dependence

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Jul 28, 2010
Registry last updated
Jul 31, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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