Trial Outcomes & Findings for Ketamine Infusion for Comorbid PTSD and Chronic Pain (NCT NCT04322968)
NCT ID: NCT04322968
Last Updated: 2020-12-22
Results Overview
Severity of PTSD symptoms; items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). The IES-R yields a total score (ranging from 0 to 88); higher scores mean worse symptoms
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
41 participants
Primary outcome timeframe
24 hrs post-infusion
Results posted on
2020-12-22
Participant Flow
Participant milestones
| Measure |
Chronic Pain With PTSD+IV Ketamine Infusion
A single low dose iv ketamine infusion (0.5 mg/kg) administered over 40 min.
|
Chronic Pain With PTSD+IV Ketorolac Infusion
A single iv infusion of ketorolac (15 mg) administered over 40 min.
|
Chronic Pain Without PTSD+IV Ketamine Infusion
A single low dose iv ketamine infusion (0.5 mg/kg) administered over 40 min.
|
Chronic Pain Without PTSD+IV Ketorolac Infusion
A single iv infusion of ketorolac (15 mg) administered over 40 min.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
9
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ketamine Infusion for Comorbid PTSD and Chronic Pain
Baseline characteristics by cohort
| Measure |
Chronic Pain With PTSD+IV Ketamine Infusion
n=10 Participants
A single low dose ketamine infusion as compared to the IV infusion of active placebo - ketorolac on chronic pain and PTSD symptoms.: Subjects were randomized into 4 treatment groups: chronic pain subjects treated with ketorolac, chronic pain subjects treated with ketamine, chronic pain+PTSD subjects treated with ketorolac, and chronic pain+PTSD subjects treated with ketamine.
|
Chronic Pain With PTSD+IV Ketorolac Infusion
n=9 Participants
A single low dose ketamine infusion as compared to the IV infusion of active placebo - ketorolac on chronic pain and PTSD symptoms.: Subjects were randomized into 4 treatment groups: chronic pain subjects treated with ketorolac, chronic pain subjects treated with ketamine, chronic pain+PTSD subjects treated with ketorolac, and chronic pain+PTSD subjects treated with ketamine.
|
Chronic Pain Without PTSD+IV Ketamine Infusion
n=10 Participants
A single low dose ketamine infusion as compared to the IV infusion of active placebo - ketorolac on chronic pain and PTSD symptoms.: Subjects were randomized into 4 treatment groups: chronic pain subjects treated with ketorolac, chronic pain subjects treated with ketamine, chronic pain+PTSD subjects treated with ketorolac, and chronic pain+PTSD subjects treated with ketamine.
|
Chronic Pain Without PTSD+IV Ketorolac Infusion
n=10 Participants
A single low dose ketamine infusion as compared to the IV infusion of active placebo - ketorolac on chronic pain and PTSD symptoms.: Subjects were randomized into 4 treatment groups: chronic pain subjects treated with ketorolac, chronic pain subjects treated with ketamine, chronic pain+PTSD subjects treated with ketorolac, and chronic pain+PTSD subjects treated with ketamine.
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 24 hrs post-infusionSeverity of PTSD symptoms; items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). The IES-R yields a total score (ranging from 0 to 88); higher scores mean worse symptoms
Outcome measures
| Measure |
Chronic Pain With PTSD+IV Ketamine Infusion
n=10 Participants
A single low dose ketamine infusion as compared to the IV infusion of active placebo - ketorolac on chronic pain and PTSD symptoms.: Subjects were randomized into 4 treatment groups: chronic pain subjects treated with ketorolac, chronic pain subjects treated with ketamine, chronic pain+PTSD subjects treated with ketorolac, and chronic pain+PTSD subjects treated with ketamine.
|
Chronic Pain With PTSD+IV Ketorolac Infusion
n=9 Participants
A single low dose ketamine infusion as compared to the IV infusion of active placebo - ketorolac on chronic pain and PTSD symptoms.: Subjects were randomized into 4 treatment groups: chronic pain subjects treated with ketorolac, chronic pain subjects treated with ketamine, chronic pain+PTSD subjects treated with ketorolac, and chronic pain+PTSD subjects treated with ketamine.
|
Chronic Pain Without PTSD+IV Ketamine Infusion
n=10 Participants
A single low dose ketamine infusion as compared to the IV infusion of active placebo - ketorolac on chronic pain and PTSD symptoms.: Subjects were randomized into 4 treatment groups: chronic pain subjects treated with ketorolac, chronic pain subjects treated with ketamine, chronic pain+PTSD subjects treated with ketorolac, and chronic pain+PTSD subjects treated with ketamine.
|
Chronic Pain Without PTSD+IV Ketorolac Infusion
n=10 Participants
A single low dose ketamine infusion as compared to the IV infusion of active placebo - ketorolac on chronic pain and PTSD symptoms.: Subjects were randomized into 4 treatment groups: chronic pain subjects treated with ketorolac, chronic pain subjects treated with ketamine, chronic pain+PTSD subjects treated with ketorolac, and chronic pain+PTSD subjects treated with ketamine.
|
|---|---|---|---|---|
|
Impact of Event Scale-Revised (IES-R)
|
36.33333333 units on a scale
Standard Deviation 17.27715254
|
37 units on a scale
Standard Deviation 15.77973384
|
10.44444444 units on a scale
Standard Deviation 14.34495653
|
15.64705882 units on a scale
Standard Deviation 17.05484233
|
PRIMARY outcome
Timeframe: 24 hrs post-infusionSeverity of chronic pain symptoms; using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100; a higher score indicates greater pain intensity.
Outcome measures
| Measure |
Chronic Pain With PTSD+IV Ketamine Infusion
n=10 Participants
A single low dose ketamine infusion as compared to the IV infusion of active placebo - ketorolac on chronic pain and PTSD symptoms.: Subjects were randomized into 4 treatment groups: chronic pain subjects treated with ketorolac, chronic pain subjects treated with ketamine, chronic pain+PTSD subjects treated with ketorolac, and chronic pain+PTSD subjects treated with ketamine.
|
Chronic Pain With PTSD+IV Ketorolac Infusion
n=9 Participants
A single low dose ketamine infusion as compared to the IV infusion of active placebo - ketorolac on chronic pain and PTSD symptoms.: Subjects were randomized into 4 treatment groups: chronic pain subjects treated with ketorolac, chronic pain subjects treated with ketamine, chronic pain+PTSD subjects treated with ketorolac, and chronic pain+PTSD subjects treated with ketamine.
|
Chronic Pain Without PTSD+IV Ketamine Infusion
n=10 Participants
A single low dose ketamine infusion as compared to the IV infusion of active placebo - ketorolac on chronic pain and PTSD symptoms.: Subjects were randomized into 4 treatment groups: chronic pain subjects treated with ketorolac, chronic pain subjects treated with ketamine, chronic pain+PTSD subjects treated with ketorolac, and chronic pain+PTSD subjects treated with ketamine.
|
Chronic Pain Without PTSD+IV Ketorolac Infusion
n=10 Participants
A single low dose ketamine infusion as compared to the IV infusion of active placebo - ketorolac on chronic pain and PTSD symptoms.: Subjects were randomized into 4 treatment groups: chronic pain subjects treated with ketorolac, chronic pain subjects treated with ketamine, chronic pain+PTSD subjects treated with ketorolac, and chronic pain+PTSD subjects treated with ketamine.
|
|---|---|---|---|---|
|
Visual Analogue Scale (VAS)
|
37.22222222 units on a scale
Standard Deviation 24.69705336
|
49.66666667 units on a scale
Standard Deviation 23.44141634
|
29.88888889 units on a scale
Standard Deviation 24.15286962
|
38.70588235 units on a scale
Standard Deviation 28.12197696
|
SECONDARY outcome
Timeframe: 1 week post-infusionSeverity of PTSD symptoms; items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). The IES-R yields a total score (ranging from 0 to 88); higher scores mean worse symptoms
Outcome measures
| Measure |
Chronic Pain With PTSD+IV Ketamine Infusion
n=10 Participants
A single low dose ketamine infusion as compared to the IV infusion of active placebo - ketorolac on chronic pain and PTSD symptoms.: Subjects were randomized into 4 treatment groups: chronic pain subjects treated with ketorolac, chronic pain subjects treated with ketamine, chronic pain+PTSD subjects treated with ketorolac, and chronic pain+PTSD subjects treated with ketamine.
|
Chronic Pain With PTSD+IV Ketorolac Infusion
n=9 Participants
A single low dose ketamine infusion as compared to the IV infusion of active placebo - ketorolac on chronic pain and PTSD symptoms.: Subjects were randomized into 4 treatment groups: chronic pain subjects treated with ketorolac, chronic pain subjects treated with ketamine, chronic pain+PTSD subjects treated with ketorolac, and chronic pain+PTSD subjects treated with ketamine.
|
Chronic Pain Without PTSD+IV Ketamine Infusion
n=10 Participants
A single low dose ketamine infusion as compared to the IV infusion of active placebo - ketorolac on chronic pain and PTSD symptoms.: Subjects were randomized into 4 treatment groups: chronic pain subjects treated with ketorolac, chronic pain subjects treated with ketamine, chronic pain+PTSD subjects treated with ketorolac, and chronic pain+PTSD subjects treated with ketamine.
|
Chronic Pain Without PTSD+IV Ketorolac Infusion
n=10 Participants
A single low dose ketamine infusion as compared to the IV infusion of active placebo - ketorolac on chronic pain and PTSD symptoms.: Subjects were randomized into 4 treatment groups: chronic pain subjects treated with ketorolac, chronic pain subjects treated with ketamine, chronic pain+PTSD subjects treated with ketorolac, and chronic pain+PTSD subjects treated with ketamine.
|
|---|---|---|---|---|
|
Impact of Event Scale-Revised (IES-R)
|
28.22 units on a scale
Standard Deviation 22.60
|
33.66666667 units on a scale
Standard Deviation 20.43281674
|
11.44 units on a scale
Standard Deviation 17.47
|
13.41 units on a scale
Standard Deviation 16.84
|
SECONDARY outcome
Timeframe: 1 week post-infusionSeverity of chronic pain symptoms; using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100; a higher score indicates greater pain intensity.
Outcome measures
| Measure |
Chronic Pain With PTSD+IV Ketamine Infusion
n=10 Participants
A single low dose ketamine infusion as compared to the IV infusion of active placebo - ketorolac on chronic pain and PTSD symptoms.: Subjects were randomized into 4 treatment groups: chronic pain subjects treated with ketorolac, chronic pain subjects treated with ketamine, chronic pain+PTSD subjects treated with ketorolac, and chronic pain+PTSD subjects treated with ketamine.
|
Chronic Pain With PTSD+IV Ketorolac Infusion
n=9 Participants
A single low dose ketamine infusion as compared to the IV infusion of active placebo - ketorolac on chronic pain and PTSD symptoms.: Subjects were randomized into 4 treatment groups: chronic pain subjects treated with ketorolac, chronic pain subjects treated with ketamine, chronic pain+PTSD subjects treated with ketorolac, and chronic pain+PTSD subjects treated with ketamine.
|
Chronic Pain Without PTSD+IV Ketamine Infusion
n=10 Participants
A single low dose ketamine infusion as compared to the IV infusion of active placebo - ketorolac on chronic pain and PTSD symptoms.: Subjects were randomized into 4 treatment groups: chronic pain subjects treated with ketorolac, chronic pain subjects treated with ketamine, chronic pain+PTSD subjects treated with ketorolac, and chronic pain+PTSD subjects treated with ketamine.
|
Chronic Pain Without PTSD+IV Ketorolac Infusion
n=10 Participants
A single low dose ketamine infusion as compared to the IV infusion of active placebo - ketorolac on chronic pain and PTSD symptoms.: Subjects were randomized into 4 treatment groups: chronic pain subjects treated with ketorolac, chronic pain subjects treated with ketamine, chronic pain+PTSD subjects treated with ketorolac, and chronic pain+PTSD subjects treated with ketamine.
|
|---|---|---|---|---|
|
Visual Analogue Scale (VAS)
|
48.22 units on a scale
Standard Deviation 31.59
|
52.88 units on a scale
Standard Deviation 21.55
|
43.33 units on a scale
Standard Deviation 19.28
|
48.23 units on a scale
Standard Deviation 21.72
|
SECONDARY outcome
Timeframe: 1 week post-infusionPopulation: BPI- pain scale and pain interference
Severity of pain, impact of pain on daily function, location of pain, pain medications and amount of pain relief in the past 24 hours or the past week; No scoring algorithm, but "worst pain" or the arithmetic mean of the four severity items can be used as measures of pain severity (a range of 0-10, with 10 being worse scores); the arithmetic mean of the seven interference items can be used as a measure of pain interference (a range of 0-10, with 10 being worse scores). The total score is reported for severity items and interference items, which range from 0-40 and 0-70, respectively. Higher values represent worse outcome.
Outcome measures
| Measure |
Chronic Pain With PTSD+IV Ketamine Infusion
n=10 Participants
A single low dose ketamine infusion as compared to the IV infusion of active placebo - ketorolac on chronic pain and PTSD symptoms.: Subjects were randomized into 4 treatment groups: chronic pain subjects treated with ketorolac, chronic pain subjects treated with ketamine, chronic pain+PTSD subjects treated with ketorolac, and chronic pain+PTSD subjects treated with ketamine.
|
Chronic Pain With PTSD+IV Ketorolac Infusion
n=9 Participants
A single low dose ketamine infusion as compared to the IV infusion of active placebo - ketorolac on chronic pain and PTSD symptoms.: Subjects were randomized into 4 treatment groups: chronic pain subjects treated with ketorolac, chronic pain subjects treated with ketamine, chronic pain+PTSD subjects treated with ketorolac, and chronic pain+PTSD subjects treated with ketamine.
|
Chronic Pain Without PTSD+IV Ketamine Infusion
n=10 Participants
A single low dose ketamine infusion as compared to the IV infusion of active placebo - ketorolac on chronic pain and PTSD symptoms.: Subjects were randomized into 4 treatment groups: chronic pain subjects treated with ketorolac, chronic pain subjects treated with ketamine, chronic pain+PTSD subjects treated with ketorolac, and chronic pain+PTSD subjects treated with ketamine.
|
Chronic Pain Without PTSD+IV Ketorolac Infusion
n=10 Participants
A single low dose ketamine infusion as compared to the IV infusion of active placebo - ketorolac on chronic pain and PTSD symptoms.: Subjects were randomized into 4 treatment groups: chronic pain subjects treated with ketorolac, chronic pain subjects treated with ketamine, chronic pain+PTSD subjects treated with ketorolac, and chronic pain+PTSD subjects treated with ketamine.
|
|---|---|---|---|---|
|
Brief Pain Inventory (Short Form)
Pain interference Scale
|
38.62 units on a scale
Standard Deviation 24.03
|
25.66 units on a scale
Standard Deviation 20.32
|
9.62 units on a scale
Standard Deviation 7.44
|
28.33 units on a scale
Standard Deviation 21.96
|
|
Brief Pain Inventory (Short Form)
Pain severity Scale
|
20.75 units on a scale
Standard Deviation 10.55
|
14.66 units on a scale
Standard Deviation 9.53
|
12.75 units on a scale
Standard Deviation 5.44
|
22.66 units on a scale
Standard Deviation 9.13
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline-1 week post-infusionPatient self report used to qualify side effects by identifying and evaluating the tolerability of each symptoms; 20 items; higher scores mean worse side effects
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline-1 week post-infusionDissociative, psychotomimetic, and manic symptoms; 27-item scale with 19 subject-rated items and 8 items scored by an observer; higher scores mean worse present-state dissociative symptomatology
Outcome measures
Outcome data not reported
Adverse Events
Chronic Pain With PTSD+IV Ketamine Infusion
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Chronic Pain With PTSD+IV Ketorolac Infusion
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Chronic Pain Without PTSD+IV Ketamine Infusion
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Chronic Pain Without PTSD+IV Ketorolac Infusion
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
Dr. Alisher Dadabayev, Pain POC
VA Ann Arbor Healthcare System
Phone: 734-222-7639
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place