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SSRI and Buprenorphine

Primary Purpose

Opiate Dependence, Depression

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

escitalopram

placebo

About this trial

This is an interventional treatment trial for Opiate Dependence focused on measuring opiate use, depression, buprenorphine, escitalopram

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Butler Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

placebo

escitalopram

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Participants Who Dropped Out of Buprenorphine Treatment

Drop-out is defined as 7 or more days of missed Buprenorphine doses

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT00475878

First Posted

May 18, 2007

Last Updated

March 5, 2012

Sponsor

Butler Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00475878

Brief Title

SSRI and Buprenorphine

Official Title

Antidepressants During Office-Based Buprenorphine

Study Type

Interventional

2. Study Status

Record Verification Date

March 2012

Overall Recruitment Status

Completed

Study Start Date

December 2006 (undefined)

Primary Completion Date

September 2009 (Actual)

Study Completion Date

September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Butler Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Opiate Dependence, Depression

Keywords

opiate use, depression, buprenorphine, escitalopram

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

147 (Actual)

8. Arms, Groups, and Interventions

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Title

escitalopram

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

escitalopram

Intervention Description

10mg escitalopram/day for 3 months

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

placebo capsule/day for 3 months

Primary Outcome Measure Information:

Title

Percentage of Participants Who Dropped Out of Buprenorphine Treatment

Description

Drop-out is defined as 7 or more days of missed Buprenorphine doses

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Depressive Symptoms

Description

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.

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael D Stein, M.D.

Organizational Affiliation

Rhode Island Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Butler Hospital

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02906

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

24521036

Citation

Tsui JI, Anderson BJ, Strong DR, Stein MD. Craving predicts opioid use in opioid-dependent patients initiating buprenorphine treatment: a longitudinal study. Am J Drug Alcohol Abuse. 2014 Mar;40(2):163-9. doi: 10.3109/00952990.2013.848875. Epub 2014 Feb 12.

Results Reference

derived

PubMed Identifier

23891461

Citation

Cioe PA, Anderson BJ, Stein MD. Change in symptoms of erectile dysfunction in depressed men initiating buprenorphine therapy. J Subst Abuse Treat. 2013 Nov-Dec;45(5):451-6. doi: 10.1016/j.jsat.2013.06.004. Epub 2013 Jul 23.

Results Reference

derived

PubMed Identifier

22864399

Citation

Strong DR, Brown RA, Sims M, Herman DS, Anderson BJ, Stein MD. Persistence on a stress-challenge task before initiating buprenorphine treatment was associated with successful transition from opioid use to early abstinence. J Addict Med. 2012 Sep;6(3):219-25. doi: 10.1097/ADM.0b013e31825d927f.

Results Reference

derived

PubMed Identifier

21924552

Citation

Tsui JI, Herman DS, Kettavong M, Anderson BJ, Stein MD. Escitalopram is associated with reductions in pain severity and pain interference in opioid dependent patients with depressive symptoms. Pain. 2011 Nov;152(11):2640-2644. doi: 10.1016/j.pain.2011.08.011. Epub 2011 Sep 15.

Results Reference

derived

PubMed Identifier

21491290

Citation

Tsui JI, Herman DS, Kettavong M, Anderson BJ, Stein MD. Chronic pain and hepatitis C virus infection in opioid dependent injection drug users. J Addict Dis. 2011 Apr;30(2):91-7. doi: 10.1080/10550887.2011.554775.

Results Reference

derived

PubMed Identifier

20598836

Citation

Stein MD, Herman DS, Kettavong M, Cioe PA, Friedmann PD, Tellioglu T, Anderson BJ. Antidepressant treatment does not improve buprenorphine retention among opioid-dependent persons. J Subst Abuse Treat. 2010 Sep;39(2):157-66. doi: 10.1016/j.jsat.2010.05.014. Epub 2010 Jul 3.

Results Reference

derived

Learn more about this trial

SSRI and Buprenorphine

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