Study of Treatment for Opioid Dependence and Anxiety Disorders

Anxiety Disorders Clinical Trial

Official title:

Behavioral Treatment Development for Co-occurring Opioid Dependence and Anxiety Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02252068
• Other study ID #: K23DA035297
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: December 19, 2019

Study information

• Verified date: November 2020
• Source: Mclean Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: December 19, 2019
• Est. primary completion date: October 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Opiate Addiction
• Opioid-Related Disorders

Intervention

Behavioral:
• I-CBT
New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders.
• IDC
Individual Drug Counseling manual that has demonstrated efficacy for the treatment of drug dependence.

Locations

Country	Name	City	State
United States	McLean Hospital	Belmont	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Mclean Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient Satisfaction	Assessed by the Client Satisfaction Questionnaire (CSQ), this measure assesses patient satisfaction with treatment. Higher scores reflect higher satisfaction (better outcome). The scores range from 8-32.	Week 12
Primary	Urine-confirmed Self-reported Weeks of Opioid Use	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	Week 12
Primary	Anxiety Symptom Severity	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.	Week 12
Secondary	Quality of Life - General Health Score	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).	Week 12
Secondary	Non-opioid Substance Use	Days of other substance use in the past 30 days	Week 12
Secondary	Functional Impairment	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.	Week 12