Anxiety Disorders, Opiate Addiction
Conditions
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.
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.
Interventions
Sponsors
Mclean Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urine-confirmed Self-reported Weeks of Opioid Use | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life - General Health Score | 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). |
| Non-opioid Substance Use | Week 12 | Days of other substance use in the past 30 days |
| Functional Impairment | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction | 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. |
Countries
United States
Participant flow
Pre-assignment details
In the randomized controlled trial, 6 participants completed a baseline assessment but dropped out prior to randomization.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 5 |
| I-CBT RCT 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. | 13 |
| 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. | 13 |
| Total | 31 |
Baseline characteristics
| Characteristic | I-CBT Feasibility Pilot | Total | IDC RCT | I-CBT RCT |
|---|---|---|---|---|
| Age, Continuous | 31.8 years STANDARD_DEVIATION 8.3 | 32.7 years STANDARD_DEVIATION 9.6 | 31.8 years STANDARD_DEVIATION 9.6 | 33.9 years STANDARD_DEVIATION 10.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 30 Participants | 13 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 31 Participants | 13 Participants | 13 Participants |
| Region of Enrollment United States | 5 participants | 31 participants | 13 participants | 13 participants |
| Sex: Female, Male Female | 1 Participants | 8 Participants | 3 Participants | 4 Participants |
| Sex: Female, Male Male | 4 Participants | 23 Participants | 10 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 5 | 0 / 13 | 0 / 13 |
| other Total, other adverse events | 0 / 5 | 0 / 13 | 0 / 13 |
| serious Total, serious adverse events | 0 / 5 | 0 / 13 | 0 / 13 |
Outcome results
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.
Time frame: Week 12
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| I-CBT Feasibility Pilot | Anxiety Symptom Severity | 9.3 score on a scale | Standard Deviation 3.1 |
| RCT: I-CBT | Anxiety Symptom Severity | 14.5 score on a scale | Standard Deviation 8.2 |
| RCT IDC | Anxiety Symptom Severity | 13.0 score on a scale | Standard Deviation 8.4 |
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
Time frame: Week 12
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| I-CBT Feasibility Pilot | Urine-confirmed Self-reported Weeks of Opioid Use | 1 weeks | Standard Deviation 1.73 |
| RCT: I-CBT | Urine-confirmed Self-reported Weeks of Opioid Use | .36 weeks | Standard Deviation 1.2 |
| RCT IDC | Urine-confirmed Self-reported Weeks of Opioid Use | .31 weeks | Standard Deviation 0.85 |
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.
Time frame: Week 12
Population: Due to partial missing data, 2 participants are missing from the RCT ICBT arm and 3 from the RCT IDC arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| I-CBT Feasibility Pilot | Functional Impairment | .15 score on a scale | Standard Deviation 0.14 |
| RCT: I-CBT | Functional Impairment | .10 score on a scale | Standard Deviation 0.1 |
| RCT IDC | Functional Impairment | .07 score on a scale | Standard Deviation 0.05 |
Secondary
Non-opioid Substance Use
Days of other substance use in the past 30 days
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| I-CBT Feasibility Pilot | Non-opioid Substance Use | 9.3 days | Standard Deviation 16.2 |
| RCT: I-CBT | Non-opioid Substance Use | 4.8 days | Standard Deviation 9.3 |
| RCT IDC | Non-opioid Substance Use | 7.8 days | Standard Deviation 13.6 |
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).
Time frame: Week 12
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| I-CBT Feasibility Pilot | Quality of Life - General Health Score | 5.7 score on a scale | Standard Deviation 2.9 |
| RCT: I-CBT | Quality of Life - General Health Score | 5.9 score on a scale | Standard Deviation 1.2 |
| RCT IDC | Quality of Life - General Health Score | 6.8 score on a scale | Standard Deviation 1.5 |
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.
Time frame: Week 12
Population: Due to partial missing data, 2 participants are missing from the RCT ICBT arm and 2 from the RCT IDC arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| I-CBT Feasibility Pilot | Patient Satisfaction | 32 score on a scale | Standard Deviation 0 |
| RCT: I-CBT | Patient Satisfaction | 26.9 score on a scale | Standard Deviation 4.8 |
| RCT IDC | Patient Satisfaction | 29.4 score on a scale | Standard Deviation 3.2 |