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Study of Treatment for Opioid Dependence and Anxiety Disorders

Primary Purpose

Anxiety Disorders, Opiate Addiction

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
I-CBT
IDC
Sponsored by
Mclean Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • McLean Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Experimental

Active Comparator

Arm Label

I-CBT feasibility pilot

I-CBT randomized trial

IDC randomized trial

Arm Description

Open trial of I-CBT

I-CBT in randomized trial.

Comparison condition (Individualized Drug Counseling) in randomized trial.

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

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).
Non-opioid Substance Use
Days of other substance use in the past 30 days
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.

Full Information

First Posted
September 25, 2014
Last Updated
November 10, 2020
Sponsor
Mclean Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02252068
Brief Title
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

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
October 24, 2019 (Actual)
Study Completion Date
December 19, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mclean Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders, Opiate Addiction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
I-CBT feasibility pilot
Arm Type
Other
Arm Description
Open trial of I-CBT
Arm Title
I-CBT randomized trial
Arm Type
Experimental
Arm Description
I-CBT in randomized trial.
Arm Title
IDC randomized trial
Arm Type
Active Comparator
Arm Description
Comparison condition (Individualized Drug Counseling) in randomized trial.
Intervention Type
Behavioral
Intervention Name(s)
I-CBT
Intervention Description
New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders.
Intervention Type
Behavioral
Intervention Name(s)
IDC
Intervention Description
Individual Drug Counseling manual that has demonstrated efficacy for the treatment of drug dependence.
Primary Outcome Measure Information:
Title
Urine-confirmed Self-reported Weeks of Opioid Use
Description
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
Time Frame
Week 12
Title
Anxiety Symptom Severity
Description
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.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Quality of Life - General Health Score
Description
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).
Time Frame
Week 12
Title
Non-opioid Substance Use
Description
Days of other substance use in the past 30 days
Time Frame
Week 12
Title
Functional Impairment
Description
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.
Time Frame
Week 12
Other Pre-specified Outcome Measures:
Title
Patient Satisfaction
Description
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.
Time Frame
Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca K McHugh, PhD
Organizational Affiliation
Mclean Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
McLean Hospital
City
Belmont
State/Province
Massachusetts
ZIP/Postal Code
02478
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Study of Treatment for Opioid Dependence and Anxiety Disorders

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