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OpenTrials
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NCT Number: NCT02252068

Study of Treatment for Opioid Dependence and Anxiety Disorders

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 treatments available for co-occurring opioid dependence and anxiety. The ultimate aims of this trial are the development and testing of a novel integrated cognitive behavioral treatment (I-CBT) for co-occurring opioid dependence and anxiety disorders. This clinical trial consists of two phases: (1) open-trial pilot (2) randomized control trial. We hypothesize that I-CBT will be a feasible and acceptable treatment that will result in significant reductions in anxiety and opioid use.

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Key information

Conditions

Anxiety Disorders Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opiate Addiction Opioid-Related Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McLean Hospital

Belmont, Massachusetts, 02478, United States

About this study

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 anxiety symptoms will be measured as the primary clinical outcome, along with measures of feasibility and patient satisfaction. These results will be used to further refine the treatment manual and to evaluate whether this treatment may enhance outcomes for adults with co-occurring opioid dependence and anxiety disorders.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

I-CBT

Behavioral

New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders.

IDC

Behavioral

Individual Drug Counseling manual that has demonstrated efficacy for the treatment of drug dependence.

Primary outcomes

  1. Urine-confirmed Self-reported Weeks of Opioid Use

    Time frame: Week 12

    Number of weeks of opioid use at Week 12 for the last 4 weeks of treatment (Weeks 9-12), as assessed by self-report and validated by urine drug screen

  2. Anxiety Symptom Severity

    Time frame: Week 12

    Hamilton Anxiety Rating Scale (HADS) score. Measure assesses the severity of anxiety symptoms. Total scale scores are reported. Higher scores reflect worse outcome. The range of possible scores is 0-56.

Secondary outcomes

  1. Quality of Life - General Health Score

    Time frame: Week 12

    Assessed by the World Health Organization Quality of Life measure, measure reflects overall health as an indicator of quality of life. The scale range of possible scores is 2-10, with higher scores reflected better outcome (i.e., better general health).

  2. Non-opioid Substance Use

    Time frame: Week 12

    Days of other substance use in the past 30 days

  3. Functional Impairment

    Time frame: Week 12

    Assessed by the Addiction Severity Index (ASI) Drug Severity Score, this score reflects the severity of functional impairment due to drug use. Higher scores reflect more interference (worse outcome) and the range of scores is 0-1.

Other outcomes

  1. Patient Satisfaction

    Time frame: Week 12

    Assessed by the Client Satisfaction Questionnaire (CSQ), this measure assesses patient satisfaction with treatment. Higher scores reflect higher satisfaction (better outcome). The scores range from 8-32.

Sponsors and collaborators

Lead sponsor

Mclean Hospital

Other

Registry information

Official study title

Behavioral Treatment Development for Co-occurring Opioid Dependence and Anxiety Disorders

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Sep 29, 2014
Registry last updated
Nov 17, 2020

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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