Study of Treatment for Opioid Dependence and Anxiety Disorders

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Anxiety Disorders, Opiate Addiction

Intervention / Treatment
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* Behavioral: I-CBT
* Behavioral: IDC


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: I-CBT feasibility pilot<br>Open trial of I-CBT | Behavioral: I-CBT<br>* New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders.<br>|
| Experimental: I-CBT randomized trial<br>I-CBT in randomized trial. | Behavioral: I-CBT<br>* New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders.<br>|
| Active Comparator: IDC randomized trial<br>Comparison condition (Individualized Drug Counseling) in randomized trial. | Behavioral: IDC<br>* Individual Drug Counseling manual that has demonstrated efficacy for the treatment of drug dependence.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urine-confirmed Self-reported Weeks of Opioid Use | 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 | Week 12 | 
| Anxiety Symptom Severity | 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. | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life - General Health Score | 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). | Week 12 | 
| Non-opioid Substance Use | Days of other substance use in the past 30 days | Week 12 | 
| Functional Impairment | 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. | Week 12 |