Anxiety DisordersNCT02252068

Study of Treatment for Opioid Dependence and Anxiety Disorders

A study testing I-CBT and IDC in people with Anxiety Disorders and Opiate Addiction, run by Mclean Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Anxiety Disorders, Opiate Addiction
What is being tested?: I-CBT and IDC
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 37 participants
Where: 1 siteUnited States
Study dates: Jan 2015to 19 Dec 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

McLean Hospital
Belmont, Massachusetts, 02478

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions: Anxiety Disorders, Opiate Addiction
Being tested: I-CBT, IDC
Medical subject headings: Anxiety Disorders, Opioid-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT02252068
Study group	Role	What they receive
I-CBT feasibility pilot	Other	Open trial of I-CBT Receives: Behavioral: I-CBT
I-CBT randomized trial	Experimental	I-CBT in randomized trial. Receives: Behavioral: I-CBT
IDC randomized trial	Active comparator	Comparison condition (Individualized Drug Counseling) in randomized trial. Receives: Behavioral: IDC

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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.
Measured: Week 12

Secondary outcomes (3)

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).
Measured: Week 12
Non-opioid Substance Use
Days of other substance use in the past 30 days
Measured: Week 12
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.
Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 201519 Dec 2019

First posted29 Sep 2014 (estimated)
Study startJan 2015
Primary completion24 Oct 2019
Study completion19 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Anxiety DisordersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 37 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02252068
Sponsor's protocol ID: K23DA035297
Status last verified: Nov 2020
First submitted: 25 Sep 2014
Last updated: 17 Nov 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Anxiety Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Behavioral Treatment Development for Co-occurring Opioid Dependence and Anxiety Disorders
ClinicalTrials.gov ID: NCT02252068
Acronym / sponsor ID: K23DA035297
Conditions: Anxiety Disorders, Opiate Addiction
Study type: Interventional
Recruitment status: Completed
Enrolment: 37 participants (actual)
Lead sponsor: Mclean HospitalUniversity, hospital or other
Study start: Jan 2015
Primary completion: 24 Oct 2019 (actual)
Study completion: 19 Dec 2019 (actual)
First posted: 29 Sep 2014 (estimated)
Results: Posted 17 Nov 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
I-CBT feasibility pilot	Other	Behavioral: I-CBTOpen trial of I-CBT
I-CBT randomized trial	Experimental	Behavioral: I-CBTI-CBT in randomized trial.
IDC randomized trial	Active comparator	Behavioral: IDCComparison condition (Individualized Drug Counseling) in randomized trial.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (6 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
I-CBTNew cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders.	Behavioural	I-CBT feasibility pilot, I-CBT randomized trial
IDCIndividual Drug Counseling manual that has demonstrated efficacy for the treatment of drug dependence.	Behavioural	IDC randomized trial

Primary outcome

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
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.

3 secondary outcomes

Quality of Life - General Health Score
Time frame: Week 12
Non-opioid Substance Use
Time frame: Week 12
Functional Impairment
Time frame: Week 12

Results and safety

Results posted to the registry on 17 Nov 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
I-CBT Feasibility Pilot	5	3
RCT I-CBT	13	13
RCT IDC	13	13

Primary outcome: Urine-confirmed Self-reported Weeks of Opioid Use

Time frame: Week 12. Mean (Standard Deviation). Unit: weeks

Measure	I-CBT Feasibility Pilot n = 3	RCT: I-CBT n = 11	RCT IDC n = 13
Value	1 (1.73)	.36 (1.2)	.31 (.85)

Population analysed: Due to partial missing data, the analysis population does not reflect the full sample. Specifically, missing data for 2 participants in RCT: I-CBT arm.

Primary outcome: Anxiety Symptom Severity

Time frame: Week 12. Mean (Standard Deviation). Unit: score on a scale

Measure	I-CBT Feasibility Pilot n = 3	RCT: I-CBT n = 12	RCT IDC n = 13
Value	9.3 (3.1)	14.5 (8.2)	13.0 (8.4)

Population analysed: Due to partial missing data, not all participants are included in this analysis. Specifically, missing data for 1 participant in the RCT: I-CBT arm.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
I-CBT Feasibility Pilot	0 of 5 (0%)	0 of 5 (0%)	1 of 5
RCT I-CBT	0 of 13 (0%)	0 of 13 (0%)	0 of 13
RCT IDC	0 of 13 (0%)	0 of 13 (0%)	0 of 13

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Rebecca K McHugh, PhD principal investigator

Mclean Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing I-CBT and IDC in people with Anxiety Disorders and Opiate Addiction, run by Mclean Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Urine-confirmed Self-reported Weeks of Opioid Use (time frame: Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02252068.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2020.