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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| I-CBT feasibility pilot | Other | Open trial of I-CBT |
|
| I-CBT randomized trial | Experimental | I-CBT in randomized trial. |
|
| IDC randomized trial | Active Comparator | Comparison condition (Individualized Drug Counseling) in randomized trial. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| I-CBT | Behavioral | New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Week 12 |
| Non-opioid Substance Use |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rebecca K McHugh, PhD | Mclean Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McLean Hospital | Belmont | Massachusetts | 02478 | United States |
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In the randomized controlled trial, 6 participants completed a baseline assessment but dropped out prior to randomization.
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| ID | Title | Description |
|---|---|---|
| FG000 | I-CBT Feasibility Pilot | Open trial of I-CBT I-CBT: New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders. |
| FG001 | RCT I-CBT | Randomized controlled trial: Integrated Cognitive-Behavioral Therapy Arm I-CBT: New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders. |
| FG002 | RCT IDC | Randomized Controlled Trial: Individual Drug Counseling Arm IDC: Individual Drug Counseling manual that has demonstrated efficacy for the treatment of drug dependence. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | I-CBT Feasibility Pilot | Open trial of I-CBT I-CBT: New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders. |
| BG001 | I-CBT RCT |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | 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. | Posted | Mean | Standard Deviation | weeks | Week 12 |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | I-CBT Feasibility Pilot | Open trial of I-CBT I-CBT: New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. R. Kathryn McHugh | McLean Hospital | 617-855-2000 | kmchugh@mclean.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 30, 2018 | Sep 11, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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| IDC | Behavioral | Individual Drug Counseling manual that has demonstrated efficacy for the treatment of drug dependence. |
|
Days of other substance use in the past 30 days |
| 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. | Week 12 |
Randomized control trial of I-CBT vs ICD
I-CBT: New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders.
| BG002 | IDC RCT | Randomized control trial of I-CBT vs ICD IDC: Individual Drug Counseling manual that has demonstrated efficacy for the treatment of drug dependence. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| OG002 | RCT IDC | Randomized control trial of I-CBT vs ICD IDC: Individual Drug Counseling manual that has demonstrated efficacy for the treatment of drug dependence. |
|
|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Week 12 |
|
|
|
| Secondary | 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). | Due to partial missing data, not all participants are included in this analysis. Specifically 2 people are missing from the RCT:I-CBT arm and 3 from the RCT IDC arm. | Posted | Mean | Standard Deviation | score on a scale | Week 12 |
|
|
|
| Secondary | Non-opioid Substance Use | Days of other substance use in the past 30 days | Posted | Mean | Standard Deviation | days | Week 12 |
|
|
|
| Secondary | 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. | Due to partial missing data, 2 participants are missing from the RCT ICBT arm and 3 from the RCT IDC arm. | Posted | Mean | Standard Deviation | score on a scale | Week 12 |
|
|
|
| Other Pre-specified | Patient Satisfaction | 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. | Due to partial missing data, 2 participants are missing from the RCT ICBT arm and 2 from the RCT IDC arm. | Posted | Mean | Standard Deviation | score on a scale | Week 12 |
|
|
|
| 1 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | RCT I-CBT | Randomized controlled trial: Integrated Cognitive-Behavioral Therapy Arm I-CBT: New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders. | 0 | 13 | 0 | 13 | 0 | 13 |
| EG002 | RCT IDC | Randomized Controlled Trial: Individual Drug Counseling Arm IDC: Individual Drug Counseling manual that has demonstrated efficacy for the treatment of drug dependence. | 0 | 13 | 0 | 13 | 0 | 13 |
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