Study of Treatment for Opioid Dependence and Anxiety Disorders

November 10, 2020 updated by: McHugh, R. Kathryn, Mclean Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Belmont, Massachusetts, United States, 02478
        • McLean Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: I-CBT feasibility pilot
Open trial of I-CBT
Behavioral: I-CBT
New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders.
Experimental: I-CBT randomized trial
I-CBT in randomized trial.
Behavioral: I-CBT
New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders.
Active Comparator: IDC randomized trial
Comparison condition (Individualized Drug Counseling) in randomized trial.
Behavioral: IDC
Individual Drug Counseling manual that has demonstrated efficacy for the treatment of drug dependence.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Week 12
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.
Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life - General Health Score
Time Frame: Week 12
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
Non-opioid Substance Use
Time Frame: Week 12
Days of other substance use in the past 30 days
Week 12
Functional Impairment
Time Frame: Week 12
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Satisfaction
Time Frame: Week 12
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mclean Hospital

Investigators

  • Principal Investigator: Rebecca K McHugh, PhD, McLean Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

October 24, 2019

Study Completion (Actual)

December 19, 2019

Study Registration Dates

First Submitted

September 25, 2014

First Submitted That Met QC Criteria

September 25, 2014

First Posted (Estimate)

September 29, 2014

Study Record Updates

Last Update Posted (Actual)

November 17, 2020

Last Update Submitted That Met QC Criteria

November 10, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K23DA035297 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anxiety Disorders

Clinical Trials on I-CBT

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malawi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe