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

May 18, 2007
March 5, 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 ] [ Designated as safety issue: No ]
Drop-out is defined as 7 or more days of missed Buprenorphine doses
buprenorphine adherence
Complete list of historical versions of study NCT00475878 on ClinicalTrials.gov Archive Site
Depressive Symptoms [ Time Frame: 3 months ] [ Designated as safety issue: No ]
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
Not Provided
Not Provided
 
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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
147
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
Both
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00475878
DA022207, 0807-002
Yes
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