Trial Outcomes & Findings for Pain, Inflammation and Opioid Craving (NCT NCT04190563)
NCT ID: NCT04190563
Last Updated: 2026-08-13
Results Overview
Investigators will assess opioid craving using the Opioid Craving Scale, a participant-reported measure of opioid craving. This is a continuous measure that is quantified as a total scale score representing an average of the 3 items, with a range from 0-10, with higher scores reflecting more craving. This outcome is the mean score at a single time point, immediately following completion of the intervention.
COMPLETED
NA
83 participants
immediately after the intervention
2026-08-13
Participant Flow
Participant milestones
| Measure |
Pain Education
Brief behavioral education on pain. This includes a standardized script providing basic education on pain and responses to pain and an acute induction of pain.
Pain Education: Experimenter-administered education.
|
Pain De-Catastrophizing
Brief behavioral education on how to modify the interpretation of pain. This includes a standardized script, a scripted practice application and application of the skill during an acute pain induction.
Pain De-Catastrophizing: Experimenter-administered education and skill practice.
|
|---|---|---|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
|
Overall Study
STARTED
|
45
|
38
|
|
Overall Study
COMPLETED
|
45
|
38
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
1 participant declined to answer the question.
Baseline characteristics by cohort
| Measure |
Pain De-Catastrophizing
n=38 Participants
Brief behavioral education on how to modify the interpretation of pain.
Pain De-Catastrophizing: Experimenter-administered education and skill practice.
|
Pain Education
n=45 Participants
Brief behavioral education on pain.
Pain Education: Experimenter-administered education.
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.66 years
STANDARD_DEVIATION 8.83 • n=38 Participants
|
40.38 years
STANDARD_DEVIATION 9.99 • n=45 Participants
|
39.13 years
STANDARD_DEVIATION 9.52 • n=83 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=38 Participants • 1 participant declined to answer the question.
|
15 Participants
n=44 Participants • 1 participant declined to answer the question.
|
28 Participants
n=82 Participants • 1 participant declined to answer the question.
|
|
Sex: Female, Male
Male
|
25 Participants
n=38 Participants • 1 participant declined to answer the question.
|
29 Participants
n=44 Participants • 1 participant declined to answer the question.
|
54 Participants
n=82 Participants • 1 participant declined to answer the question.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=38 Participants
|
8 Participants
n=45 Participants
|
13 Participants
n=83 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=38 Participants
|
35 Participants
n=45 Participants
|
68 Participants
n=83 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=38 Participants
|
2 Participants
n=45 Participants
|
2 Participants
n=83 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=38 Participants
|
1 Participants
n=45 Participants
|
1 Participants
n=83 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=38 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=83 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=38 Participants
|
2 Participants
n=45 Participants
|
2 Participants
n=83 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=38 Participants
|
4 Participants
n=45 Participants
|
10 Participants
n=83 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=38 Participants
|
31 Participants
n=45 Participants
|
61 Participants
n=83 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=38 Participants
|
3 Participants
n=45 Participants
|
3 Participants
n=83 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=38 Participants
|
4 Participants
n=45 Participants
|
6 Participants
n=83 Participants
|
PRIMARY outcome
Timeframe: immediately after the interventionInvestigators will assess opioid craving using the Opioid Craving Scale, a participant-reported measure of opioid craving. This is a continuous measure that is quantified as a total scale score representing an average of the 3 items, with a range from 0-10, with higher scores reflecting more craving. This outcome is the mean score at a single time point, immediately following completion of the intervention.
Outcome measures
| Measure |
Pain De-Catastrophizing
n=38 Participants
Brief behavioral education on how to modify the interpretation of pain.
Pain De-Catastrophizing: Experimenter-administered education and skill practice.
|
Pain Education
n=45 Participants
Brief behavioral education on pain.
Pain Education: Experimenter-administered education.
|
|---|---|---|
|
Craving
|
4.21 score on a scale
Standard Deviation 3.10
|
4.93 score on a scale
Standard Deviation 2.93
|
Adverse Events
Pain De-Catastrophizing
Pain Education
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