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Carvedilol for Psychostimulant Dependence

This study has been completed.
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
Baylor College of Medicine
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT01171183
First received: July 27, 2010
Last updated: July 29, 2015
Last verified: July 2015
Results First Received: June 10, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Cocaine Dependence
Cocaine Withdrawal
Interventions: Drug: controlled release carvedilol
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo Placebo: Placebo
Carvedilol Controlled Release

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

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


Participant Flow for 2 periods

Period 1:   Residential Facility (Weeks 1-2)
    Placebo   Carvedilol Controlled Release
STARTED   15 [1]   16 [2] 
COMPLETED   13   10 
NOT COMPLETED   2   6 
Withdrawal by Subject                2                2 
Protocol Violation                0                1 
BP outside of study parameters                0                3 
[1] Those who were admitted to the residential facility and received at least one dose of study med.
[2] Subjects receiving at least one dose of study med. One did not due to BP outside study parameters.

Period 2:   Outpatient Participation (Weeks 3-10)
    Placebo   Carvedilol Controlled Release
STARTED   12 [1]   9 [2] 
COMPLETED   2   4 
NOT COMPLETED   10   5 
Withdrawal by Subject                2                2 
Lost to Follow-up                7                3 
Use of contraindicated med: PI term                1                0 
[1] One subject completed the residential stay but withdrew prior to starting the outpatient phase.
[2] One subject completed the residential stay but was discharged due to protocol noncompliance.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Those who were admitted to the residential unit and received at least one dose of medication. The data for one person in the carvedilol arm was excluded from analyses as the person did not meet inclusion criteria for the study and was discharged by the third day.

Reporting Groups
  Description
Placebo Placebo: Placebo
Carvedilol Controlled Release

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

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

Total Total of all reporting groups

Baseline Measures
   Placebo   Carvedilol Controlled Release   Total 
Overall Participants Analyzed 
[Units: Participants]
 15   15   30 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   15   15   30 
>=65 years   0   0   0 
Gender 
[Units: Participants]
     
Female   1   6   7 
Male   14   9   23 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   0   0   0 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   14   12   26 
White   1   3   4 
More than one race   0   0   0 
Unknown or Not Reported   0   0   0 
Region of Enrollment 
[Units: Participants]
     
United States   15   15   30 


  Outcome Measures
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1.  Primary:   Urine Toxicology Screens   [ Time Frame: based on thrice weekly urine results during the 10-week outpatient phase ]

2.  Secondary:   Retention   [ Time Frame: 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Small numbers of participants analyzed. Primary outcome measure based on successfully transition to outpatient phase of the study.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Alison Oliveto, PhD
Organization: University of Arkansas for Medical Sciences
phone: 501-526-8441
e-mail: olivetoalison@uams.edu



Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT01171183     History of Changes
Other Study ID Numbers: 2P50DA018197 ( US NIH Grant/Contract Award Number )
Study First Received: July 27, 2010
Results First Received: June 10, 2015
Last Updated: July 29, 2015
Health Authority: United States: Food and Drug Administration