Study of Treatment for Opioid Dependence and Anxiety Disorders

Not Applicable

Completed

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 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
I-CBT feasibility pilot	I-CBT	Open trial of I-CBT
I-CBT randomized trial	I-CBT	I-CBT in randomized trial.
IDC randomized trial	IDC	Comparison condition (Individualized Drug Counseling) in randomized trial.

Primary Outcome Measures

Name	Time	Method
Urine-confirmed Self-reported Weeks of Opioid Use	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
Anxiety Symptom Severity	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 Outcome Measures

Name	Time	Method
Non-opioid Substance Use	Week 12	Days of other substance use in the past 30 days
Functional Impairment	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.
Quality of Life - General Health Score	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).