Behavioral Treatment Development for Co-occurring Opioid Dependence and Anxiety Disorders
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Anxiety Disorders
- Sponsor
- Mclean Hospital
- Enrollment
- 37
- Locations
- 1
- Primary Endpoint
- Urine-confirmed Self-reported Weeks of Opioid Use
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
McHugh, R. Kathryn
Associate Psychologist, Division of Alcohol and Drug Abuse
Mclean Hospital
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
Outcomes
Primary Outcomes
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
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
- Non-opioid Substance Use(Week 12)
- Functional Impairment(Week 12)
- Quality of Life - General Health Score(Week 12)