SSRI and Buprenorphine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michael Stein, MD, Butler Hospital
ClinicalTrials.gov Identifier:
NCT00475878
First received: May 18, 2007
Last updated: March 5, 2012
Last verified: March 2012
Results First Received: June 28, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Opiate Dependence
Depression
Interventions: Drug: escitalopram
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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Placebo placebo pill, daily for 12 weeks, for individuals entering buprenorphine treatment for opioid dependence
10 mg Escitalopram 10 mg escitalopram pill, daily for 12 weeks, for individuals entering buprenorphine treatment for opioid dependence

Participant Flow:   Overall Study
    Placebo     10 mg Escitalopram  
STARTED     75     72  
COMPLETED     75     72  
NOT COMPLETED     0     0  



  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.
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Reporting Groups
  Description
Placebo placebo pill, daily for 12 weeks, for individuals entering buprenorphine treatment for opioid dependence
10 mg Escitalopram 10 mg escitalopram pill, daily for 12 weeks, for individuals entering buprenorphine treatment for opioid dependence
Total Total of all reporting groups

Baseline Measures
    Placebo     10 mg Escitalopram     Total  
Number of Participants  
[units: participants]
  75     72     147  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     75     72     147  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  36.8  ± 9.8     38.3  ± 9.6     37.5  ± 9.9  
Gender  
[units: participants]
     
Female     18     17     35  
Male     57     55     112  
Region of Enrollment  
[units: participants]
     
United States     75     72     147  



  Outcome Measures
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1.  Primary:   Percentage of Participants Who Dropped Out of Buprenorphine Treatment   [ Time Frame: 3 months ]

2.  Secondary:   Depressive Symptoms   [ Time Frame: 3 months ]


  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
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  More Information
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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: Dr. Michael Stein
Organization: Butler Hospital
phone: 401-455-6646
e-mail: michael_stein@brown.edu


No publications provided by Butler Hospital

Publications automatically indexed to this study:


Responsible Party: Michael Stein, MD, Butler Hospital
ClinicalTrials.gov Identifier: NCT00475878     History of Changes
Other Study ID Numbers: DA022207, 0807-002
Study First Received: May 18, 2007
Results First Received: June 28, 2011
Last Updated: March 5, 2012
Health Authority: United States: Institutional Review Board