Clinical trial NCT02252068: Study of Treatment for Opioid Dependence and Anxiety Disorders
Official title: Behavioral Treatment Development for Co-occurring Opioid Dependence and Anxiety Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorders
Opiate Addiction
Lead sponsor: Mclean Hospital
Sponsor class: OTHER
First posted: 2014-09-29
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Urine-confirmed Self-reported Weeks of Opioid Use
timeFrame: Week 12
measure: Anxiety Symptom Severity
timeFrame: Week 12
Secondary outcomes:
measure: Quality of Life - General Health Score
timeFrame: Week 12
measure: Non-opioid Substance Use
timeFrame: Week 12
measure: Functional Impairment
timeFrame: Week 12
Other outcomes:
measure: Patient Satisfaction
timeFrame: Week 12
Locations:
city: Belmont
country: United States
facility: McLean Hospital
state: Massachusetts
Study officials:
affiliation: Mclean Hospital
name: Rebecca K McHugh, PhD
role: PRINCIPAL_INVESTIGATOR
References: