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Cocaine Withdrawal and Pharmacotherapy Response (Carvedilol)

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ClinicalTrials.gov Identifier: NCT00566969
Recruitment Status : Completed
First Posted : December 4, 2007
Results First Posted : October 10, 2016
Last Update Posted : February 13, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Mehmet Sofuoglu, Yale University

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

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

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) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      15  44.1%      14  37.8%      11  31.4%      40  37.7% 
Male      19  55.9%      23  62.2%      24  68.6%      66  62.3% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
       
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      12  35.3%      10  27.0%      4  11.4%      26  24.5% 
White      21  61.8%      24  64.9%      25  71.4%      70  66.0% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      1   2.9%      3   8.1%      6  17.1%      10   9.4% 


  Outcome Measures

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


  Serious Adverse Events


  Other Adverse Events


  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

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: February 13, 2018