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SSRI and Buprenorphine

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ClinicalTrials.gov Identifier: NCT00475878
Recruitment Status : Completed
First Posted : May 21, 2007
Results First Posted : April 3, 2012
Last Update Posted : April 3, 2012
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Opiate Dependence Depression Drug: escitalopram Drug: placebo Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 147 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Antidepressants During Office-Based Buprenorphine
Study Start Date : December 2006
Primary Completion Date : September 2009
Study Completion Date : September 2009


Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: placebo Drug: placebo
placebo capsule/day for 3 months
Active Comparator: escitalopram Drug: escitalopram
10mg escitalopram/day for 3 months


Outcome Measures

Primary Outcome Measures :
  1. Percentage of Participants Who Dropped Out of Buprenorphine Treatment [ Time Frame: 3 months ]
    Drop-out is defined as 7 or more days of missed Buprenorphine doses


Secondary Outcome Measures :
  1. Depressive Symptoms [ Time Frame: 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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

Responsible Party: Michael Stein, MD, Principal Investigator, Butler Hospital
ClinicalTrials.gov Identifier: NCT00475878     History of Changes
Other Study ID Numbers: DA022207
0807-002
First Posted: May 21, 2007    Key Record Dates
Results First Posted: April 3, 2012
Last Update Posted: April 3, 2012
Last Verified: March 2012

Keywords provided by Michael Stein, MD, Butler Hospital:
opiate use
depression
buprenorphine
escitalopram

Additional relevant MeSH terms:
Depression
Opioid-Related Disorders
Behavioral Symptoms
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Buprenorphine
Dexetimide
Citalopram
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents