NCT00475878

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
147

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2006

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 21, 2007

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

April 3, 2012

Completed
Last Updated

April 3, 2012

Status Verified

March 1, 2012

Enrollment Period

2.8 years

First QC Date

May 18, 2007

Results QC Date

June 28, 2011

Last Update Submit

March 5, 2012

Conditions

Opiate DependenceDepression

Keywords

opiate usedepressionbuprenorphineescitalopram

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants Who Dropped Out of Buprenorphine Treatment

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

    3 months

Secondary Outcomes (1)

  • Depressive Symptoms

    3 months

Study Arms (2)

placebo

PLACEBO COMPARATOR
Drug: placebo

escitalopram

ACTIVE COMPARATOR
Drug: escitalopram

Interventions

escitalopramDRUG

10mg escitalopram/day for 3 months

escitalopram
placeboDRUG

placebo capsule/day for 3 months

placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • opiate dependence
  • Ham-D \> 14

You may not qualify if:

  • no psychiatric contraindications to using escitalopram
  • no medical contraindications to using escitalopram
  • methadone dose \< 30
  • no current SSRI use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

Related Publications (6)

  • 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.

    PMID: 24521036DERIVED

  • 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.

    PMID: 23891461DERIVED

  • 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.

    PMID: 22864399DERIVED

  • 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.

    PMID: 21924552DERIVED

  • 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.

    PMID: 21491290DERIVED

  • 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.

    PMID: 20598836DERIVED

MeSH Terms

Conditions

Opioid-Related DisordersDepression

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic ChemicalsNitrilesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Dr. Michael Stein
Organization
Butler Hospital
michael_stein@brown.edu
401-455-6646

Study Officials

  • Michael D Stein, M.D.

    Rhode Island Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 18, 2007

First Posted

May 21, 2007

Study Start

December 1, 2006

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

April 3, 2012

Results First Posted

April 3, 2012

Record last verified: 2012-03

Locations

US(1)