N/A
Completed N=31
Study of Treatment for Opioid Dependence and Anxiety Disorders
Anxiety · Opiate Addiction
Source: ClinicalTrials.gov NCT02252068 ↗
Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcomePrimary: Urine-confirmed Self-reported Weeks of Opioid Use — 1; .36; .31 weeks
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Urine-confirmed Self-reported Weeks of Opioid Use |
1; .36; .31 | — |
| PRIMARY Anxiety Symptom Severity |
9.3; 14.5; 13.0 | — |
| SECONDARY Quality of Life - General Health Score |
5.7; 5.9; 6.8 | — |
| SECONDARY Non-opioid Substance Use |
9.3; 4.8; 7.8 | — |
| SECONDARY Functional Impairment |
.15; .10; .07 | — |
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
Data sourced from ClinicalTrials.gov (NCT02252068). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.