SSRI and Buprenorphine

Phase 3

Completed

• Conditions: Opiate Dependence; Depression
• Interventions: Drug: placebo; Drug: escitalopram

• Registration Number: NCT00475878
• Lead Sponsor: Butler Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2007-05-18
• Study First Submitted QC: 2007-05-18
• Study First Posted: 2007-05-21
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Results First Submitted: 2011-06-28
• Status Verified: 2012-03
• Results First Submitted QC: 2012-03-05
• Last Update Submitted: 2012-03-05
• Results First Posted: 2012-04-03
• Last Update Posted: 2012-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 147

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	-
escitalopram	escitalopram	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Dropped Out of Buprenorphine Treatment	3 months	Drop-out is defined as 7 or more days of missed Buprenorphine doses

Secondary Outcome Measures

Name	Time	Method
Depressive Symptoms	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.

Trial Locations

Locations (1)

Butler Hospital; 🇺🇸 Providence, Rhode Island, United States