SSRI and Buprenorphine - Full Text View

Purpose

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.

Condition	Intervention	Phase
Opiate Dependence Depression	Drug: escitalopram Drug: placebo	Phase 3

Study Type:	Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: Antidepressants Depression

Drug Information available for: Buprenorphine Buprenorphine hydrochloride Citalopram hydrobromide Citalopram Escitalopram oxalate

U.S. FDA Resources

Further study details as provided by Butler Hospital:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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.

Enrollment:	147
Study Start Date:	December 2006
Study Completion Date:	September 2009
Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: placebo	Drug: placebo placebo capsule/day for 3 months
Active Comparator: escitalopram	Drug: escitalopram 10mg escitalopram/day for 3 months

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00475878

Locations

United States, Rhode Island
Butler Hospital
Providence, Rhode Island, United States, 02906

Sponsors and Collaborators

Butler Hospital

Investigators

Principal Investigator:

Michael D Stein, M.D.

Rhode Island Hospital

More Information

No publications provided by Butler Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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):2640-4. Epub 2011 Sep 15.

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.

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. Epub 2010 Jul 3.

Responsible Party:	Michael Stein, MD, Principal Investigator, Butler Hospital
ClinicalTrials.gov Identifier:	NCT00475878 History of Changes
Other Study ID Numbers:	DA022207, 0807-002
Study First Received:	May 18, 2007
Results First Received:	June 28, 2011
Last Updated:	March 5, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Butler Hospital:

opiate use
depression
buprenorphine
escitalopram

Additional relevant MeSH terms:

Depression
Depressive Disorder
Opioid-Related Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders
Substance-Related Disorders
Dexetimide
Citalopram
Buprenorphine
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents

ClinicalTrials.gov processed this record on June 18, 2013