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Completed

NCT Number: NCT00475878

SSRI and Buprenorphine

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.

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Key information

Conditions

Opiate Dependence Behavior Behavioral Symptoms Chemically-Induced Disorders Depression Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Butler Hospital

Providence, Rhode Island, 02906, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Escitalopram

Drug

10mg escitalopram/day for 3 months

Placebo

Drug

placebo capsule/day for 3 months

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Butler Hospital

Other

Registry information

Official study title

Antidepressants During Office-Based Buprenorphine

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
May 21, 2007
Registry last updated
Apr 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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