SSRI and 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Antidepressants During Office-Based Buprenorphine|
- 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
- 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.
|Study Start Date:||December 2006|
|Study Completion Date:||September 2009|
|Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
|Placebo Comparator: placebo||
placebo capsule/day for 3 months
|Active Comparator: escitalopram||
10mg escitalopram/day for 3 months
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00475878
|United States, Rhode Island|
|Providence, Rhode Island, United States, 02906|
|Principal Investigator:||Michael D Stein, M.D.||Rhode Island Hospital|