Opioid-use Disorder
Conditions
Brief summary
Opioid use disorder is a major public health problem. Although there are effective treatments for this disorder, many people still relapse and thus there is a need for new treatments to improve outcomes. People who have a strong emotional and physical response to stress are at a higher risk of relapse. The goal of this project is to test the effect of strategies to reduce response to stress in people diagnosed with opioid use disorder. Men and women diagnosed with opioid use disorder will be recruited for a one-session study. Participants will be randomly assigned to one of three brief instructional conditions followed by a brief laboratory stress test. Investigators hypothesize that, compared to education about stress, brief strategies to help people cope with negative emotions will reduce responses to stress and increase tolerance of stress. If this hypothesis is supported, it will inform the development of new treatments to improve outcome in opioid use disorder.
Interventions
BEHAVIORALPsychoeducational Control
The Psychoeducational Control condition will consist of a brief script describing the body's response to stress and will not discuss cognition or the role of interpretation or affect labeling during stress.
BEHAVIORALAffect Regulation
In the Affect Regulation Condition, participants will be provided instructions for how to reappraise negative thoughts in the context of stress by developing statements consistent with more benign interpretations of stress (e.g., This won't last forever.).
BEHAVIORALAffect Labelling
In the Affect Labeling Condition, participants will be provided with instructions for how to verbalize their emotional response during the stressor.
Sponsors
Mclean Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Investigator)
Masking description
The study PI and data analyst will be blind to study condition. The experimenter will and participant will be aware of the study condition because this is a behavioral intervention.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years or older * primary diagnosis of opioid use disorder * ability to read and provide informed consent
Exclusion criteria
* major psychiatric or medical condition that would interfere with the ability to complete study procedures * current opioid withdrawal * presence of another current substance use disorder at a severity requiring acute treatment * endocrine disease or current steroid prescription * opioid-positive urine drug screen or breath alcohol test on the data or enrollment (not including prescribed medications)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Negative Affect | Change measured over 2 time points during this 1-session study experiment (from start of a stress induction task to completion; approximately 10-15 minutes). | Negative affect will be measured using the Negative Affect Subscale of the Positive and Negative Affect Schedule. This is a 10-item self-report measure on which respondents rate how strongly they are experiencing negative emotion. The range of scores is 10-50, with higher scores representing higher negative affect. |
| Distress Tolerance | Time-to-event outcome; during this 1-session study, this will measure time to outcome (discontinuation of task) from time of initiation of the stress induction task up to a maximum of 15 minutes later. | Distress tolerance will be measured using the Computerized Mirror Tracing Persistence Task. This is a computer-based task in which participants trace a mirror on the screen using the cursor. Participants are asked to persist at the task for as long as possible. Time to discontinuation is used as a measure of distress tolerance (in seconds). Longer duration reflects better tolerance of distress. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cortisol Response | Change measured over 2 time points during this 1-session study (from start of stress induction task to 30 minutes after completion; approximately 40-45 minutes). | Cortisol levels will be measured using saliva samples. Salivary cortisol levels are measured on a continuous scale (micrograms/deciliter). |
| Change in Skin Conductance Level | Change measured over 2 time points during this 1-session study (prior to and during the stress induction task; approximately 10-15 minutes). | Skin conductance level is a physiological outcome that will be measured using electrodes placed on participants fingers, connected to a Biopac MP150 system with an ECG amplifier. Change will be measures by subtracting the maximum value during the stress task from the value at the end of a baseline recording. |
| Change in Opioid Craving | Change measured over 2 time points during this 1-session study (immediately prior to and at the completion of the stress induction task; approximately 10-15 minutes). | Self-report of opioid craving will be measured using the Opioid Craving Scale, a 3-item measure, with a range of 0-30, with higher scores representing strong opioid craving. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Psychoeducational Control Psychoeducational Control: The Psychoeducational Control condition will consist of a brief script describing the body's response to stress and will not discuss cognition or the role of interpretation or affect labeling during stress. | 39 |
| Affect Regulation Condition Affect Regulation: In the Affect Regulation Condition, participants will be provided instructions for how to reappraise negative thoughts in the context of stress by developing statements consistent with more benign interpretations of stress (e.g., This won't last forever.). | 40 |
| Affect Labelling Condition Affect Labelling: In the Affect Labeling Condition, participants will be provided with instructions for how to verbalize their emotional response during the stressor. | 40 |
| Total | 119 |
Baseline characteristics
| Characteristic | Psychoeducational Control | Affect Regulation Condition | Affect Labelling Condition | Total |
|---|---|---|---|---|
| Age, Continuous | 41.08 years STANDARD_DEVIATION 11.79 | 43.83 years STANDARD_DEVIATION 11.14 | 40.40 years STANDARD_DEVIATION 10 | 41.87 years STANDARD_DEVIATION 10.94 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 0 Participants | 4 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 34 Participants | 39 Participants | 36 Participants | 109 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 1 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 3 Participants | 5 Participants | 9 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 | 3 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) White | 31 Participants | 36 Participants | 34 Participants | 101 Participants |
| Sex: Female, Male Female | 12 Participants | 16 Participants | 12 Participants | 40 Participants |
| Sex: Female, Male Male | 27 Participants | 24 Participants | 28 Participants | 79 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 0 / 40 | 0 / 40 |
| other Total, other adverse events | 0 / 39 | 0 / 40 | 0 / 40 |
| serious Total, serious adverse events | 0 / 39 | 0 / 40 | 0 / 40 |
Outcome results
Primary
Change in Negative Affect
Negative affect will be measured using the Negative Affect Subscale of the Positive and Negative Affect Schedule. This is a 10-item self-report measure on which respondents rate how strongly they are experiencing negative emotion. The range of scores is 10-50, with higher scores representing higher negative affect.
Time frame: Change measured over 2 time points during this 1-session study experiment (from start of a stress induction task to completion; approximately 10-15 minutes).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psychoeducational Control | Change in Negative Affect | 1.67 scores on a scale | Standard Deviation 8.7 |
| Affect Regulation Condition | Change in Negative Affect | 1.25 scores on a scale | Standard Deviation 6.36 |
| Affect Labelling Condition | Change in Negative Affect | 3.60 scores on a scale | Standard Deviation 6.93 |
Primary
Distress Tolerance
Distress tolerance will be measured using the Computerized Mirror Tracing Persistence Task. This is a computer-based task in which participants trace a mirror on the screen using the cursor. Participants are asked to persist at the task for as long as possible. Time to discontinuation is used as a measure of distress tolerance (in seconds). Longer duration reflects better tolerance of distress.
Time frame: Time-to-event outcome; during this 1-session study, this will measure time to outcome (discontinuation of task) from time of initiation of the stress induction task up to a maximum of 15 minutes later.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psychoeducational Control | Distress Tolerance | 244.72 seconds | Standard Deviation 151.72 |
| Affect Regulation Condition | Distress Tolerance | 227.07 seconds | Standard Deviation 169.48 |
| Affect Labelling Condition | Distress Tolerance | 217.34 seconds | Standard Deviation 148.67 |
Secondary
Change in Cortisol Response
Cortisol levels will be measured using saliva samples. Salivary cortisol levels are measured on a continuous scale (micrograms/deciliter).
Time frame: Change measured over 2 time points during this 1-session study (from start of stress induction task to 30 minutes after completion; approximately 40-45 minutes).
Population: Values more than 3 standard deviations from the mean were excluded.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psychoeducational Control | Change in Cortisol Response | -0.07 micrograms/deciliter | Standard Deviation 1.45 |
| Affect Regulation Condition | Change in Cortisol Response | -0.07 micrograms/deciliter | Standard Deviation 1.02 |
| Affect Labelling Condition | Change in Cortisol Response | -0.63 micrograms/deciliter | Standard Deviation 1.82 |
Secondary
Change in Opioid Craving
Self-report of opioid craving will be measured using the Opioid Craving Scale, a 3-item measure, with a range of 0-30, with higher scores representing strong opioid craving.
Time frame: Change measured over 2 time points during this 1-session study (immediately prior to and at the completion of the stress induction task; approximately 10-15 minutes).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psychoeducational Control | Change in Opioid Craving | -0.26 score on a scale | Standard Deviation 1.6 |
| Affect Regulation Condition | Change in Opioid Craving | -0.18 score on a scale | Standard Deviation 1.57 |
| Affect Labelling Condition | Change in Opioid Craving | 0.60 score on a scale | Standard Deviation 2.01 |
Secondary
Change in Skin Conductance Level
Skin conductance level is a physiological outcome that will be measured using electrodes placed on participants fingers, connected to a Biopac MP150 system with an ECG amplifier. Change will be measures by subtracting the maximum value during the stress task from the value at the end of a baseline recording.
Time frame: Change measured over 2 time points during this 1-session study (prior to and during the stress induction task; approximately 10-15 minutes).
Population: Participants with data missing due to technical issues with data collection were excluded.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psychoeducational Control | Change in Skin Conductance Level | 0.68 microsiemens | Standard Deviation 1.12 |
| Affect Regulation Condition | Change in Skin Conductance Level | 0.80 microsiemens | Standard Deviation 0.94 |
| Affect Labelling Condition | Change in Skin Conductance Level | 1.16 microsiemens | Standard Deviation 1.21 |