We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cocaine Withdrawal and Pharmacotherapy Response (Carvedilol)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00566969
First Posted: December 4, 2007
Last Update Posted: October 10, 2016
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.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Mehmet Sofuoglu, Yale University
Results First Submitted: August 16, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Health Services Research
Conditions: Cocaine Dependence
Opiate Dependence
Interventions: Drug: sugar pill
Drug: Carvedilol 25 mg
Drug: Carvedilol 50 mg

  Participant Flow
  Hide Participant Flow

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
Sugar Pill

To be compared to active drug

sugar pill: randomly given 25mg or 50mg of a sugar pill or the active comparator

Carvedilol 25 mg

To be compared to sugar pill

carvedilol: randomly assigned to 25mg or 50mg of Carvedilol or sugar pill, dose determined by height and weight.

Carvedilol 50 mg

To be compared to sugar pill

carvedilol: randomly assigned to 25mg or 50mg of Carvedilol or sugar pill, dose determined by height and weight.


Participant Flow:   Overall Study
    Sugar Pill   Carvedilol 25 mg   Carvedilol 50 mg
STARTED   34   37   35 
COMPLETED   19   28   23 
NOT COMPLETED   15   9   12 



  Baseline Characteristics
  Hide Baseline Characteristics

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.
106 subjects meeting inclusion criteria who were without exclusions and randomized to an intervention.

Reporting Groups
  Description
Sugar Pill

To be compared to active drug

sugar pill: Subjects randomized to placebo, carvedilol 25mg or 50mg

Carvedilol 25 mg

To be compared to placebo and Carvedilol 50 mg

carvedilol: subjects randomized to placebo, carvedilol 25mg or 50mg

Carvedilol 50 mg

To be compared to placebo and Carvedilol 25 mg

Carvedilol: subjects randomized to placebo, carvedilol 25mg or 50mg

Total Total of all reporting groups

Baseline Measures
   Sugar Pill   Carvedilol 25 mg   Carvedilol 50 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 34   37   35   106 
Age 
[Units: Years]
Mean (Standard Deviation)
 37.6  (9.1)   37.7  (10.9)   39.1  (10.9)   38.1  (10.3) 
Gender 
[Units: Participants]
       
Female   15   14   11   40 
Male   19   23   24   66 
Race (NIH/OMB) 
[Units: Participants]
       
American Indian or Alaska Native   0   0   0   0 
Asian   0   0   0   0 
Native Hawaiian or Other Pacific Islander   0   0   0   0 
Black or African American   12   10   4   26 
White   21   24   25   70 
More than one race   0   0   0   0 
Unknown or Not Reported   1   3   6   10 


  Outcome Measures

1.  Primary:   Percent Days Abstinent From Cocaine - Self Report   [ Time Frame: 11 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Mehmet Sofuoglu, M.D.,Ph.D.
Organization: Yale University
phone: 203-932-5711 ext 4809
e-mail: mehmet.sofuoglu@yale.edu



Responsible Party: Mehmet Sofuoglu, Yale University
ClinicalTrials.gov Identifier: NCT00566969     History of Changes
Other Study ID Numbers: NIDA R01DA014537
R01DA014537 ( U.S. NIH Grant/Contract )
DPMC ( Other Identifier: NIDA )
First Submitted: December 3, 2007
First Posted: December 4, 2007
Results First Submitted: August 16, 2016
Results First Posted: October 10, 2016
Last Update Posted: October 10, 2016