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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
History of Changes
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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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 ]
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Measure Type Primary
Measure Title Percentage of Participants Who Dropped Out of Buprenorphine Treatment
Measure Description Drop-out is defined as 7 or more days of missed Buprenorphine doses
Time Frame 3 months  
Safety Issue No  

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.
Participants who were fully eligible for the study, completed the enrollment process and began study medication were used in an intent to treat analysis.

Reporting Groups
  Description
10 mg Escitalopram in a double-blind, randomized controlled trial, participants were given 10mg escitalopram prior to buprenorphine induction
Placebo in a double-blind, randomized controlled trial, participants were given placebo prior to buprenorphine induction

Measured Values
    10 mg Escitalopram     Placebo  
Number of Participants Analyzed  
[units: participants]
 		  72     75  
Percentage of Participants Who Dropped Out of Buprenorphine Treatment  
[units: percentage of participants]
 		  33.3     44.0  


Statistical Analysis 1 for Percentage of Participants Who Dropped Out of Buprenorphine Treatment
Groups [1] All groups
Method [2] Chi-squared
P Value [3] .19
Odds Ratio (OR) [4] .64
Standard Error of the mean ± .22
95% Confidence Interval ( .33 to 1.24 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
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[2] Other relevant information, such as adjustments or degrees of freedom:
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[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
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[4] Other relevant estimation information:
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2.  Secondary:   Depressive Symptoms   [ Time Frame: 3 months ]
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  Serious Adverse Events
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  Other Adverse Events
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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.


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
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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