Status:

COMPLETED

Study of Treatment for Opioid Dependence and Anxiety Disorders

Lead Sponsor:

Mclean Hospital

Conditions:

Anxiety Disorders

Opiate Addiction

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

Anxiety is highly prevalent among individuals with opioid dependence and confers greater risk for continued opioid use and poor treatment outcomes. However, there are currently no efficacious treatmen...

Detailed Description

This Stage 1 behavioral treatment development trial involves two stages: manual development and pilot testing in an open trial, and a small randomized controlled trial. In both phases, opioid use and ...

Eligibility Criteria

Inclusion

  • age 18 or older
  • meet current Diagnostic and Statistical Manual of Mental Disorders 5th edition diagnostic criteria for opioid use disorder
  • currently prescribed pharmacotherapy for opioid dependence
  • have used opioids illicitly within the previous 90 days
  • clinically-significant anxiety
  • meet current diagnostic criteria for a Diagnostic and Statistical Manual of Mental Disorders 5th edition anxiety disorder
  • able to read and provide informed consent
  • intend to remain in the geographical area for the duration of the study period

Exclusion

  • meet criteria for a current substance use or psychiatric disorder requiring a level of care higher than outpatient
  • currently receiving cognitive behavioral therapy
  • recent initiation of a psychiatric medication, defined as less than 4 weeks on a stable dose; not including PRN medications for sleep
  • are receiving and taking an as-needed (PRN) prescription for benzodiazepines
  • presence of a psychiatric or medical condition that would interfere with participation or that requires additional care (e.g. psychosis, acute suicidality)
  • were admitted to McLean Hospital for their current treatment episode on an involuntary status

Key Trial Info

Start Date :

January 1 2015

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 19 2019

Estimated Enrollment :

37 Patients enrolled

Trial Details

Trial ID

NCT02252068

Start Date

January 1 2015

End Date

December 19 2019

Last Update

November 17 2020

Active Locations (1)

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1

McLean Hospital

Belmont, Massachusetts, United States, 02478