SSRI and Buprenorphine

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. Identifier: NCT00475878
Recruitment Status : Completed
First Posted : May 21, 2007
Results First Posted : April 3, 2012
Last Update Posted : April 3, 2012
Information provided by (Responsible Party):
Michael Stein, MD, Butler Hospital

May 18, 2007
May 21, 2007
June 28, 2011
April 3, 2012
April 3, 2012
December 2006
September 2009   (Final data collection date for primary outcome measure)
Percentage of Participants Who Dropped Out of Buprenorphine Treatment [ Time Frame: 3 months ]
Drop-out is defined as 7 or more days of missed Buprenorphine doses
buprenorphine adherence
Complete list of historical versions of study NCT00475878 on Archive Site
Depressive Symptoms [ Time Frame: 3 months ]
Depressive symptoms, as measured by self-report during study interviews, using the Beck Depression Inventory II. Scores ranged from 0-63; higher scores indicate more depressive symptoms.
mood symptoms
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SSRI and Buprenorphine
Antidepressants During Office-Based Buprenorphine
This study is designed to test whether treatment of depressive symptoms using escitalopram improves adherence to Buprenorphine and reduces symptoms of depression for individuals receiving Buprenorphine through their medical provider.
Participants interested in receiving Buprenorphine will be offered the opportunity to enroll in this study. Enrolled study participants will complete interviews at baseline and again every two weeks for a total of 8 interviews over 3 months. In this double-blind randomized controlled trial, participants will either receive a placebo or escitalopram (10mg). All participants will also be followed by their Buprenorphine clinic medical provider. Questions during the face-to-face interviews will assess mood, drug craving, pain, sleep, medication adherence and drug-related experiences. Comparison(s): Participants randomized into the medication component of the study as compared to participants randomized into the placebo component of the study.
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Opiate Dependence
  • Depression
  • Drug: escitalopram
    10mg escitalopram/day for 3 months
  • Drug: placebo
    placebo capsule/day for 3 months
  • Placebo Comparator: placebo
    Intervention: Drug: placebo
  • Active Comparator: escitalopram
    Intervention: Drug: escitalopram

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 2009
September 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • opiate dependence
  • Ham-D > 14

Exclusion Criteria:

  • no psychiatric contraindications to using escitalopram
  • no medical contraindications to using escitalopram
  • methadone dose < 30
  • no current SSRI use
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Michael Stein, MD, Butler Hospital
Butler Hospital
Not Provided
Principal Investigator: Michael D Stein, M.D. Rhode Island Hospital
Butler Hospital
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP