Study of Treatment for Opioid Dependence and Anxiety Disorders

NCT02252068 | Completed Results

• 1 other identifier: K23DA035297
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Disorders; Opiate Addiction

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Quality of Life - General Health Score

  Week 12

• Non-opioid Substance Use

  Week 12

• Functional Impairment

  Week 12

Other Outcomes (1)

• Patient Satisfaction

  Week 12

Study Arms (3)

I-CBT feasibility pilot

OTHER

Open trial of I-CBT

Behavioral: I-CBT

I-CBT randomized trial

EXPERIMENTAL

I-CBT in randomized trial.

Behavioral: I-CBT

IDC randomized trial

ACTIVE COMPARATOR

Comparison condition (Individualized Drug Counseling) in randomized trial.

Behavioral: IDC

Interventions

I-CBT BEHAVIORAL

New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders.

I-CBT feasibility pilot; I-CBT randomized trial

IDC BEHAVIORAL

Individual Drug Counseling manual that has demonstrated efficacy for the treatment of drug dependence.

IDC randomized trial

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mclean Hospital: lead

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Results Point of Contact

• Title: Dr. R. Kathryn McHugh
• Organization: McLean Hospital

kmchugh@mclean.harvard.edu

617-855-2000

Study Officials

• Rebecca K McHugh, PhD

  Mclean Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Psychologist, Division of Alcohol and Drug Abuse

Study Record Dates

• First Submitted: September 25, 2014
• First Posted: September 29, 2014
• Study Start: January 1, 2015
• Primary Completion: October 24, 2019
• Study Completion: December 19, 2019
• Last Updated: November 17, 2020
• Results First Posted: November 17, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)