Trial Outcomes & Findings for Opioid Taper Study (NCT NCT03912298)
NCT ID: NCT03912298
Last Updated: 2022-02-07
Results Overview
Pain perception will be measured using the cold-pressor test (CPT) employing procedures consistent with those described in the literature. Order of pain testing will vary, and three aspects of the pain response will be captured at each study session: evoked pain; temporal summation; and conditioned pain modulation, which map on to the hypothesized peripheral, spinal and supra-spinal mechanisms of OIH. Reported are cold-pressor pain tolerance prior to and following taper.
COMPLETED
7 participants
up to one year (length of taper individualized and varies)
2022-02-07
Participant Flow
Participant milestones
| Measure |
Chronic Pain Patients Undergoing Opioid Taper
Chronic pain patients undergoing an individualized opioid taper to a safer daily dose of opioid for up to one year.
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Opioid Taper Study
Baseline characteristics by cohort
| Measure |
Chronic Pain Patients Undergoing Opioid Taper
n=7 Participants
Chronic pain patients undergoing opioid taper
|
|---|---|
|
Age, Continuous
|
55 years
STANDARD_DEVIATION 15.49 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=5 Participants
|
|
mg morphine equivalents/day or MME/day
|
291.85 daily morphine mg equivalents
STANDARD_DEVIATION 182.62 • n=5 Participants
|
PRIMARY outcome
Timeframe: up to one year (length of taper individualized and varies)Pain perception will be measured using the cold-pressor test (CPT) employing procedures consistent with those described in the literature. Order of pain testing will vary, and three aspects of the pain response will be captured at each study session: evoked pain; temporal summation; and conditioned pain modulation, which map on to the hypothesized peripheral, spinal and supra-spinal mechanisms of OIH. Reported are cold-pressor pain tolerance prior to and following taper.
Outcome measures
| Measure |
Chronic Pain Patients Undergoing Opioid Taper
n=7 Participants
Chronic pain patients undergoing opioid taper
|
|---|---|
|
Pain Perception Measured Using the Cold-pressor Test (CPT)
pre taper pain tolerance (baseline)
|
24.01 seconds
Standard Deviation 20.63
|
|
Pain Perception Measured Using the Cold-pressor Test (CPT)
post-taper pain tolerance (timeframe variable)
|
42.02 seconds
Standard Deviation 41.83
|
PRIMARY outcome
Timeframe: up to one year (individualized, variable taper length)Conditioned pain modulation will be measured using the quantitative sensory testing (QST) employing procedures consistent with those described in the literature to capture supra-spinal mechanisms of OIH. To detect conditioned modulation, the subject is asked to verbally report the severity of pain experienced on a visual analogue scale (0- no pain, 10-worst pain ever) to a three-second painful heat stimulus (47○C) delivered at 12-15 second intervals, in the presence or absence of the non-dominant limb being immerged in a cold-water bath (12○C). The reported value is the difference between the average of pain scores reported in the absence of vs. the presence of the counter-stimulation. Reported are changes in the conditioned pain modulation assay both prior to and following taper. Taper is individualized thus length of taper varies between subjects.
Outcome measures
| Measure |
Chronic Pain Patients Undergoing Opioid Taper
n=7 Participants
Chronic pain patients undergoing opioid taper
|
|---|---|
|
Conditioned Pain Modulation Measured Using the Quantitative Sensory Testing (QST)
pre-taper conditioned pain modulation (baseline)
|
-0.14 units on a visual analogue scale
Standard Deviation 0.42
|
|
Conditioned Pain Modulation Measured Using the Quantitative Sensory Testing (QST)
post taper conditioned pain modulation (individualized taper, thus time length varies)
|
-0.40 units on a visual analogue scale
Standard Deviation 0.79
|
Adverse Events
Chronic Pain Patients Undergoing Opioid Taper
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