Carvedilol for Psychostimulant Dependence

Cocaine Dependence Clinical Trial

Official title:

Clinical Efficacy of Carvedilol for Psychostimulant Dependence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01171183
• Other study ID #: 2P50DA018197
• Secondary ID: 2P50DA018197
• Status: Completed
• Phase: Phase 2
• First received: July 27, 2010
• Last updated: July 29, 2015
• Start date: August 2010
• Est. completion date: May 2014

Study information

• Verified date: July 2015
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cocaine Dependence
• Cocaine Withdrawal
• Cocaine-Related Disorders
• Substance Withdrawal Syndrome

Intervention

Drug:
• controlled release carvedilol
carvedilol (Coreg CR) 80 mg/day in once daily dosing for 12 weeks followed by a 2-week taper
• Placebo
Placebo

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (3)

Lead Sponsor	Collaborator
University of Arkansas	Baylor College of Medicine, National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Retention	number of weeks each participant is on study protocol	12 weeks	No