MedDataX Logo

Study of Treatment for Opioid Dependence and Anxiety Disorders

NCT ID: NCT02252068

Last Updated: 2020-11-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2019-12-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anxiety Disorders Opiate Addiction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

I-CBT feasibility pilot

Open trial of I-CBT

Group Type OTHER

I-CBT

Intervention Type BEHAVIORAL

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

I-CBT randomized trial

I-CBT in randomized trial.

Group Type EXPERIMENTAL

I-CBT

Intervention Type BEHAVIORAL

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

IDC randomized trial

Comparison condition (Individualized Drug Counseling) in randomized trial.

Group Type ACTIVE_COMPARATOR

IDC

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

I-CBT

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

Intervention Type BEHAVIORAL

IDC

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mclean Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

McHugh, R. Kathryn

Associate Psychologist, Division of Alcohol and Drug Abuse

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Rebecca K McHugh, PhD

Role: PRINCIPAL_INVESTIGATOR

Mclean Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

McLean Hospital

Belmont, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

K23DA035297

Identifier Type: NIH

Identifier Source: org_study_id

View Link