Trial Outcomes & Findings for Stress Response in Opioid Use Disorder (NCT NCT03616379)
NCT ID: NCT03616379
Last Updated: 2024-04-01
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
119 participants
Primary outcome timeframe
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).
Results posted on
2024-04-01
Participant Flow
Participant milestones
| Measure |
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.
|
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.).
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
39
|
40
|
40
|
|
Overall Study
COMPLETED
|
39
|
40
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Stress Response in Opioid Use Disorder
Baseline characteristics by cohort
| Measure |
Psychoeducational Control
n=39 Participants
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.
|
Affect Regulation Condition
n=40 Participants
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.).
|
Affect Labelling Condition
n=40 Participants
Affect Labelling: In the Affect Labeling Condition, participants will be provided with instructions for how to verbalize their emotional response during the stressor.
|
Total
n=119 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
41.08 years
STANDARD_DEVIATION 11.79 • n=5 Participants
|
43.83 years
STANDARD_DEVIATION 11.14 • n=7 Participants
|
40.40 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
41.87 years
STANDARD_DEVIATION 10.94 • n=4 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
79 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
109 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
101 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Psychoeducational Control
n=39 Participants
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.
|
Affect Regulation Condition
n=40 Participants
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.).
|
Affect Labelling Condition
n=40 Participants
Affect Labelling: In the Affect Labeling Condition, participants will be provided with instructions for how to verbalize their emotional response during the stressor.
|
|---|---|---|---|
|
Change in Negative Affect
|
1.67 scores on a scale
Standard Deviation 8.70
|
1.25 scores on a scale
Standard Deviation 6.36
|
3.60 scores on a scale
Standard Deviation 6.93
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Psychoeducational Control
n=39 Participants
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.
|
Affect Regulation Condition
n=40 Participants
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.).
|
Affect Labelling Condition
n=40 Participants
Affect Labelling: In the Affect Labeling Condition, participants will be provided with instructions for how to verbalize their emotional response during the stressor.
|
|---|---|---|---|
|
Distress Tolerance
|
244.72 seconds
Standard Deviation 151.72
|
227.07 seconds
Standard Deviation 169.48
|
217.34 seconds
Standard Deviation 148.67
|
SECONDARY outcome
Timeframe: 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.
Cortisol levels will be measured using saliva samples. Salivary cortisol levels are measured on a continuous scale (micrograms/deciliter).
Outcome measures
| Measure |
Psychoeducational Control
n=36 Participants
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.
|
Affect Regulation Condition
n=34 Participants
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.).
|
Affect Labelling Condition
n=34 Participants
Affect Labelling: In the Affect Labeling Condition, participants will be provided with instructions for how to verbalize their emotional response during the stressor.
|
|---|---|---|---|
|
Change in Cortisol Response
|
-0.07 micrograms/deciliter
Standard Deviation 1.45
|
-0.07 micrograms/deciliter
Standard Deviation 1.02
|
-0.63 micrograms/deciliter
Standard Deviation 1.82
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Psychoeducational Control
n=30 Participants
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.
|
Affect Regulation Condition
n=26 Participants
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.).
|
Affect Labelling Condition
n=29 Participants
Affect Labelling: In the Affect Labeling Condition, participants will be provided with instructions for how to verbalize their emotional response during the stressor.
|
|---|---|---|---|
|
Change in Skin Conductance Level
|
0.68 microsiemens
Standard Deviation 1.12
|
0.80 microsiemens
Standard Deviation 0.94
|
1.16 microsiemens
Standard Deviation 1.21
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Psychoeducational Control
n=39 Participants
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.
|
Affect Regulation Condition
n=40 Participants
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.).
|
Affect Labelling Condition
n=40 Participants
Affect Labelling: In the Affect Labeling Condition, participants will be provided with instructions for how to verbalize their emotional response during the stressor.
|
|---|---|---|---|
|
Change in Opioid Craving
|
-0.26 score on a scale
Standard Deviation 1.60
|
-0.18 score on a scale
Standard Deviation 1.57
|
0.60 score on a scale
Standard Deviation 2.01
|
Adverse Events
Psychoeducational Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Affect Regulation Condition
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Affect Labelling Condition
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place