Study of Treatment for Opioid Dependence and Anxiety Disorders

Mass General Brigham

Status: Completed

Conditions: Opiate Addiction; Anxiety Disorders

Treatments: Behavioral: I-CBT; Behavioral: IDC

Study type: Interventional

Funder types: Other

Identifiers

NCT02252068

K23DA035297

Details and patient eligibility

About

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.

Full 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.

Enrollment: 37 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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37 participants in 3 patient groups

I-CBT feasibility pilot

Other group

Description:

Open trial of I-CBT

Treatment:

Behavioral: I-CBT

I-CBT randomized trial

Experimental group

Description:

I-CBT in randomized trial.

Treatment:

Behavioral: I-CBT

IDC randomized trial

Active Comparator group

Description:

Comparison condition (Individualized Drug Counseling) in randomized trial.

Treatment:

Behavioral: IDC