Carvedilol for Psychostimulant Dependence

NCT01171183 | Completed Phase 2 Results DMC

• 1 other identifier: 2P50DA018197
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cocaine Dependence; Cocaine Withdrawal

Keywords

cocaine dependence; cocaine withdrawal

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Retention

  12 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Carvedilol controlled release

ACTIVE COMPARATOR

controlled release carvedilol (Coreg CR) at 80 mg/day in once daily dosing

Drug: controlled release carvedilol

Interventions

controlled release carvedilol DRUG

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

Also known as: Coreg CR

Carvedilol controlled release

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Arkansas: lead
• National Institute on Drug Abuse (NIDA): collaborator
• Baylor College of Medicine: collaborator

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Carvedilol

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring

Limitations and Caveats

Small numbers of participants analyzed. Primary outcome measure based on successfully transition to outpatient phase of the study.

Results Point of Contact

• Title: Alison Oliveto, PhD
• Organization: University of Arkansas for Medical Sciences

olivetoalison@uams.edu

501-526-8441

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2010
• First Posted: July 28, 2010
• Study Start: August 1, 2010
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: July 31, 2015
• Results First Posted: July 31, 2015

Record last verified: 2015-07

Locations

US (1)