SSRI and Buprenorphine

Depression Clinical Trial

Official title:

Antidepressants During Office-Based Buprenorphine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00475878
• Other study ID #: DA022207
• Secondary ID: 0807-002
• Status: Completed
• Phase: Phase 3
• First received: May 18, 2007
• Last updated: March 5, 2012
• Start date: December 2006
• Est. completion date: September 2009

Study information

• Verified date: March 2012
• Source: Butler Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Opiate Dependence

Intervention

Drug:
• escitalopram
10mg escitalopram/day for 3 months
• placebo
placebo capsule/day for 3 months

Locations

Country	Name	City	State
United States	Butler Hospital	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Butler Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Who Dropped Out of Buprenorphine Treatment	Drop-out is defined as 7 or more days of missed Buprenorphine doses	3 months	No
Secondary	Depressive Symptoms	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.	3 months	No