NCT03146806 is a Phase 1, PHASE2 clinical trial of Intranasal ketamine in Cancer, sponsored by Emory University.

Who is sponsoring NCT03146806?

NCT03146806 is sponsored by Emory University.

What drugs are being tested in NCT03146806?

Interventions in NCT03146806: Intranasal ketamine.

What condition does NCT03146806 study?

NCT03146806 studies Cancer, Pain.

Is NCT03146806 still recruiting?

NCT03146806 is currently completed. Last updated 9 September 2021.

Are results published for NCT03146806?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-09-09 · How we verify

NCT03146806

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Intranasal (NAS) Ketamine for Cancer Pain

Completed Phase 1, PHASE2 Results posted Last updated 9 September 2021

What this trial tests

Phase 1, PHASE2 trial testing Intranasal ketamine in Cancer in 10 participants. Completed in 22 April 2020.

Timeline

25 July 2017

Primary endpoint
22 April 2020

22 April 2020

Quick facts

Lead sponsor	Emory University
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	10
Start date	25 July 2017
Primary completion	22 April 2020
Estimated completion	22 April 2020
Sites	1 location across United States

Drugs / interventions tested

Intranasal ketamine — full drug profile →

Conditions studied

Cancer — all drugs for Cancer →
Pain — all drugs for Pain →

Sponsor

Emory University

Who can join

18 and older, any sex, with Cancer or Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Bioavailability of Ketamine Primary · Baseline, Minutes 2, 30, 60, and 240 during Study Visits 1 through 4, up to 4 weeks

Blood samples were obtained at the study visits where ketamine was administered to measure the bioavailability (a pharmacokinetic characteristic) of intranasal and intravenous ketamine. Bioavailability is assessed as nanograms per milliliter (ng/mL) of ketamine circulating in blood. Each study participant received each dose of ketamine during separate study visits. Samples were obtained prior to ketamine administration, and at 2, 30, 60 and 240 minutes after medication administration, during study visits 1 through 4. The baseline sample was not collected at the first study visit as assessing p

Baseline

Group	Value	95% CI
10 mg Intravenous (IV) Ketamine	0	± 0
30 mg Intranasal Ketamine	0	± 0
50 mg Intranasal Ketamine	0	± 0

2 minutes post-ketamine administration

Group	Value	95% CI
10 mg Intranasal Ketamine	13.4	± 1.65
10 mg Intravenous (IV) Ketamine	296.4	± 1.71
30 mg Intranasal Ketamine	23.7	± 2.98
50 mg Intranasal Ketamine	33.7	± 3.86

30 minutes post-ketamine administration

Group	Value	95% CI
10 mg Intranasal Ketamine	20.3	± 2.01
10 mg Intravenous (IV) Ketamine	35.0	± 1.35
30 mg Intranasal Ketamine	48.6	± 1.67
50 mg Intranasal Ketamine	51.0	± 1.75

60 minutes post-ketamine administration

Group	Value	95% CI
10 mg Intranasal Ketamine	11.7	± 1.38
10 mg Intravenous (IV) Ketamine	16.4	± 1.70
30 mg Intranasal Ketamine	26.5	± 2.1
50 mg Intranasal Ketamine	55.8	± 2.12

240 minutes post-ketamine administration

Group	Value	95% CI
10 mg Intranasal Ketamine	0	± 0
10 mg Intravenous (IV) Ketamine	0	± 0
30 mg Intranasal Ketamine	0	± 0
50 mg Intranasal Ketamine	0	± 0

Peak Concentration (Cmax) of Ketamine Primary · Minute 2 through Minute 240 during Study Visits 1 through 4, up to 4 weeks

Blood samples were obtained at the study visits where ketamine was administered to measure the peak concentration (Cmax) of intranasal and intravenous ketamine. Peak concentration is assessed as the maximum ng/mL of ketamine circulating in blood. Each study participant received each dose of ketamine during separate study visits. Samples were obtained at 2, 30, 60 and 240 minutes after medication administration.

Group	Value	95% CI
10 mg Intranasal Ketamine	22.9	± 1.97
10 mg Intravenous (IV) Ketamine	296	± 1.71
30 mg Intranasal Ketamine	60.8	± 1.90
50 mg Intranasal Ketamine	77.6	± 2.29

Area Under the Curve of Ketamine Primary · Minute 2 through Minute 240 during Study Visits 1 through 4, up to 4 Weeks

Blood samples were obtained at the study visits where ketamine was administered to measure the elimination (a pharmacokinetic characteristic) of intranasal and intravenous ketamine. Elimination of the drug disappearing from the body is assessed as the area under the curve (AUC). Each study participant received each dose of ketamine during separate study visits. Samples were obtained at 2, 30, 60 and 240 minutes after medication administration. Each subject did not have quantitative levels at all time points. There were not enough data to construct a curve for each participant and therefore cal

Group	Value	95% CI
10 mg Intranasal Ketamine	19	± NA
10 mg Intravenous (IV) Ketamine	113	± NA
30 mg Intranasal Ketamine	46	± NA
50 mg Intranasal Ketamine	64	± NA

Time to Peak Concentration (Tmax) of Ketamine Primary · Minute 2 through Minute 240 during Study Visits 1 through 4, up to 4 weeks

Blood samples were obtained at the study visits where ketamine was administered to measure the time to peak concentration (Tmax) of intranasal and intravenous ketamine. Time is measured as minutes after administration when the maximum concentration of ketamine in blood is reached.

Group	Value	95% CI
10 mg Intranasal Ketamine	23	± 3.0
10 mg Intravenous (IV) Ketamine	2	± 1
30 mg Intranasal Ketamine	14	± 3.8
50 mg Intranasal Ketamine	16	± 4.4

Numerical Pain Rating Scale (NPRS) Score Primary · Baseline, Minutes 5, 10, 15, 30, 45, 60, 120, 180, and 240 during Study Visits 1 through 4, up to 4 weeks

The Numerical Pain Rating Scale (NPRS) was used to evaluate patient reported pain. Pain scores were recorded prior to and at 5,10,15, 30, 45, 60, 120, 180 and 240 minutes after administration of ketamine. The NPRS asks participants rate their current level of pain intensity on a scale from 0 (no pain) to 10 (worst possible pain). In general, improvements of pain severity of 1.5 points or less on NPRS could be seen as clinically irrelevant. Above that value, the cutoff point for "clinical relevance" depends on patients' baseline pain severity, and ranges from 2.4 to 5.3. Higher baseline scores

Baseline

Group	Value	95% CI
10 mg Intranasal Ketamine	7.5	6 – 8
10 mg Intravenous (IV) Ketamine	6	5 – 8
30 mg Intranasal Ketamine	5.5	5 – 7
50 mg Intranasal Ketamine	6	6 – 8

Minute 5

Group	Value	95% CI
10 mg Intranasal Ketamine	6	5 – 8
10 mg Intravenous (IV) Ketamine	1	0 – 3
30 mg Intranasal Ketamine	5	4 – 6
50 mg Intranasal Ketamine	5	3 – 5

Minute 10

Group	Value	95% CI
10 mg Intranasal Ketamine	6	5 – 8
10 mg Intravenous (IV) Ketamine	0	0 – 3
30 mg Intranasal Ketamine	3	3 – 6
50 mg Intranasal Ketamine	4	2 – 5

Minute 15

Group	Value	95% CI
10 mg Intranasal Ketamine	5	4 – 7
10 mg Intravenous (IV) Ketamine	1.5	0 – 3
30 mg Intranasal Ketamine	3.5	3 – 6
50 mg Intranasal Ketamine	3	2 – 5

Minute 30

Group	Value	95% CI
10 mg Intranasal Ketamine	4.5	2 – 7
10 mg Intravenous (IV) Ketamine	2.5	0 – 5
30 mg Intranasal Ketamine	3.5	2 – 6
50 mg Intranasal Ketamine	2	2 – 5

Minute 45

Group	Value	95% CI
10 mg Intranasal Ketamine	5	3 – 7
10 mg Intravenous (IV) Ketamine	3	0 – 5
30 mg Intranasal Ketamine	3	2 – 4
50 mg Intranasal Ketamine	2	2 – 4

Minute 60

Group	Value	95% CI
10 mg Intranasal Ketamine	4.5	3 – 6
10 mg Intravenous (IV) Ketamine	3.5	1 – 5
30 mg Intranasal Ketamine	2.5	2 – 3
50 mg Intranasal Ketamine	2	1 – 5

Minute 120

Group	Value	95% CI
10 mg Intranasal Ketamine	4.5	3 – 7
10 mg Intravenous (IV) Ketamine	3.5	1 – 4
30 mg Intranasal Ketamine	3	2 – 3
50 mg Intranasal Ketamine	2	1 – 5

Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Fatigue Score Primary · Baseline, Minutes 30, 60, and 240, during Study Visits 1 through 4, up to 4 weeks

To evaluate self-reported fatigue, participants completed the Side Effect Rating Scale for Dissociative Anesthetics (SERSDA). During visits 1 through 4, side effects were documented by SERSDA prior to administration of medication and 30, 60 and 240 minutes after ketamine administration. Participants indicated the severity of this side effect by selecting 0 (side effect is absent), 1 (weak side effect), 2 (modest side effect), 3 (bothersome side effect), or 4 (side effect is very bothersome).

Baseline

Group	Value	95% CI
10 mg Intranasal Ketamine	2.9	± 0.86
10 mg Intravenous (IV) Ketamine	1.4	± 0.84
30 mg Intranasal Ketamine	1.6	± 0.70
50 mg Intranasal Ketamine	1.5	± 1.27

Minute 30

Group	Value	95% CI
10 mg Intranasal Ketamine	1	± 1.15
10 mg Intravenous (IV) Ketamine	1.6	± 1.17
30 mg Intranasal Ketamine	1.3	± 1.06
50 mg Intranasal Ketamine	1.0	± 1.25

Minute 60

Group	Value	95% CI
10 mg Intranasal Ketamine	0.7	± 0.95
10 mg Intravenous (IV) Ketamine	1.2	± 1.23
30 mg Intranasal Ketamine	1.2	± 1.14
50 mg Intranasal Ketamine	1.2	± 1.03

Minute 240

Group	Value	95% CI
10 mg Intranasal Ketamine	0.8	± 0.92
10 mg Intravenous (IV) Ketamine	1	± 0.82
30 mg Intranasal Ketamine	0.8	± 1.03
50 mg Intranasal Ketamine	0.7	± 0.67

Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Dizziness Score Primary · Baseline, Minutes 30, 60, and 240, during Study Visits 1 through 4, up to 4 weeks

To evaluate self-reported dizziness, participants completed the Side Effect Rating Scale for Dissociative Anesthetics (SERSDA). During visits 1 through 4, side effects were documented by SERSDA prior to administration of medication and 30, 60 and 240 minutes after ketamine administration. Participants indicated the severity of this side effect by selecting 0 (side effect is absent), 1 (weak side effect), 2 (modest side effect), 3 (bothersome side effect), or 4 (side effect is very bothersome).

Baseline

Group	Value	95% CI
10 mg Intranasal Ketamine	0.6	± 0.97
10 mg Intravenous (IV) Ketamine	0.1	± 0.32
30 mg Intranasal Ketamine	0	± 0
50 mg Intranasal Ketamine	0	± 0

Minute 30

Group	Value	95% CI
10 mg Intranasal Ketamine	0.1	± 0.32
10 mg Intravenous (IV) Ketamine	0.8	± 1.14
30 mg Intranasal Ketamine	0.3	± 0.67
50 mg Intranasal Ketamine	0.5	± 0.71

Minute 60

Group	Value	95% CI
10 mg Intranasal Ketamine	0	± 0
10 mg Intravenous (IV) Ketamine	0.3	± 0.95
30 mg Intranasal Ketamine	0.1	± 0.32
50 mg Intranasal Ketamine	0.2	± 0.63

Minute 240

Group	Value	95% CI
10 mg Intranasal Ketamine	0	± 0
10 mg Intravenous (IV) Ketamine	0	± 0
30 mg Intranasal Ketamine	0	± 0
50 mg Intranasal Ketamine	0	± 0

Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Nausea Score Primary · Baseline, Minutes 30, 60, and 240, during Study Visits 1 through 4, up to 4 weeks

To evaluate self-reported nausea, participants completed the Side Effect Rating Scale for Dissociative Anesthetics (SERSDA). During visits 1 through 4, side effects were documented by SERSDA prior to administration of medication and 30, 60 and 240 minutes after ketamine administration. Participants indicated the severity of this side effect by selecting 0 (side effect is absent), 1 (weak side effect), 2 (modest side effect), 3 (bothersome side effect), or 4 (side effect is very bothersome).

Baseline

Group	Value	95% CI
10 mg Intranasal Ketamine	0.2	± 0.42
10 mg Intravenous (IV) Ketamine	0.3	± 0.67
30 mg Intranasal Ketamine	0.1	± 0.32
50 mg Intranasal Ketamine	0.1	± 0.32

Minute 30

Group	Value	95% CI
10 mg Intranasal Ketamine	0.3	± 0.95
10 mg Intravenous (IV) Ketamine	0.8	± 1.32
30 mg Intranasal Ketamine	0.4	± 0.97
50 mg Intranasal Ketamine	0.3	± 0.67

Minute 60

Group	Value	95% CI
10 mg Intranasal Ketamine	0.2	± 0.63
10 mg Intravenous (IV) Ketamine	0.6	± 1.07
30 mg Intranasal Ketamine	0.1	± 0.32
50 mg Intranasal Ketamine	0.3	± 0.67

Minute 240

Group	Value	95% CI
10 mg Intranasal Ketamine	0.1	± 0.32
10 mg Intravenous (IV) Ketamine	0	± 0
30 mg Intranasal Ketamine	0.4	± 0.97
50 mg Intranasal Ketamine	0.4	± 1.26

Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Headache Score Primary · Baseline, Minutes 30, 60, and 240, during Study Visits 1 through 4, up to 4 weeks

To evaluate self-reported headache, participants completed the Side Effect Rating Scale for Dissociative Anesthetics (SERSDA). During visits 1 through 4, side effects were documented by SERSDA prior to administration of medication and 30, 60 and 240 minutes after ketamine administration. Participants indicated the severity of this side effect by selecting 0 (side effect is absent), 1 (weak side effect), 2 (modest side effect), 3 (bothersome side effect), or 4 (side effect is very bothersome).

Baseline

Group	Value	95% CI
10 mg Intranasal Ketamine	0.2	± 0.63
10 mg Intravenous (IV) Ketamine	0	± 0
30 mg Intranasal Ketamine	0	± 0
50 mg Intranasal Ketamine	0	± 0

Minute 30

Group	Value	95% CI
10 mg Intranasal Ketamine	0	± 0
10 mg Intravenous (IV) Ketamine	0.1	± 0.32
30 mg Intranasal Ketamine	0	± 0
50 mg Intranasal Ketamine	0	± 0

Minute 60

Group	Value	95% CI
10 mg Intranasal Ketamine	0	± 0
10 mg Intravenous (IV) Ketamine	0.1	± 0.32
30 mg Intranasal Ketamine	0	± 0
50 mg Intranasal Ketamine	0	± 0

Minute 240

Group	Value	95% CI
10 mg Intranasal Ketamine	0	± 0
10 mg Intravenous (IV) Ketamine	0	± 0
30 mg Intranasal Ketamine	0	± 0
50 mg Intranasal Ketamine	0	± 0

Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Feeling of Unreality Score Primary · Baseline, Minutes 30, 60, and 240, during Study Visits 1 through 4, up to 4 weeks

To evaluate self-reported feeling of unreality, participants completed the Side Effect Rating Scale for Dissociative Anesthetics (SERSDA). During visits 1 through 4, side effects were documented by SERSDA prior to administration of medication and 30, 60 and 240 minutes after ketamine administration. Participants indicated the severity of this side effect by selecting 0 (side effect is absent), 1 (weak side effect), 2 (modest side effect), 3 (bothersome side effect), or 4 (side effect is very bothersome).

Baseline

Group	Value	95% CI
10 mg Intranasal Ketamine	0.2	± 0.63
10 mg Intravenous (IV) Ketamine	0	± 0
30 mg Intranasal Ketamine	0	± 0
50 mg Intranasal Ketamine	0	± 0

Minute 30

Group	Value	95% CI
10 mg Intranasal Ketamine	0.4	± 1.26
10 mg Intravenous (IV) Ketamine	1.3	± 1.42
30 mg Intranasal Ketamine	0.2	± 0.42
50 mg Intranasal Ketamine	0.2	± 0.42

Minute 60

Group	Value	95% CI
10 mg Intranasal Ketamine	0	± 0
10 mg Intravenous (IV) Ketamine	0.5	± 1.27
30 mg Intranasal Ketamine	0	± 0
50 mg Intranasal Ketamine	0.1	± 0.32

Minute 240

Group	Value	95% CI
10 mg Intranasal Ketamine	0	± 0
10 mg Intravenous (IV) Ketamine	0.2	± 0.63
30 mg Intranasal Ketamine	0	± 0
50 mg Intranasal Ketamine	0	± 0

Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Change in Hearing Score Primary · Baseline, Minutes 30, 60, and 240, during Study Visits 1 through 4, up to 4 weeks

To evaluate self-reported change in hearing, participants completed the Side Effect Rating Scale for Dissociative Anesthetics (SERSDA). During visits 1 through 4, side effects were documented by SERSDA prior to administration of medication and 30, 60 and 240 minutes after ketamine administration. Participants indicated the severity of this side effect by selecting 0 (side effect is absent), 1 (weak side effect), 2 (modest side effect), 3 (bothersome side effect), or 4 (side effect is very bothersome).

Baseline

Group	Value	95% CI
10 mg Intranasal Ketamine	0	± 0
10 mg Intravenous (IV) Ketamine	0	± 0
30 mg Intranasal Ketamine	0.1	± 0.32
50 mg Intranasal Ketamine	0	± 0

Minute 30

Group	Value	95% CI
10 mg Intranasal Ketamine	0	± 0
10 mg Intravenous (IV) Ketamine	0.1	± 0.32
30 mg Intranasal Ketamine	0	± 0
50 mg Intranasal Ketamine	0	± 0

Minute 60

Group	Value	95% CI
10 mg Intranasal Ketamine	0	± 0
10 mg Intravenous (IV) Ketamine	0	± 0
30 mg Intranasal Ketamine	0	± 0
50 mg Intranasal Ketamine	0	± 0

Minute 240

Group	Value	95% CI
10 mg Intranasal Ketamine	0	± 0
10 mg Intravenous (IV) Ketamine	0.3	± 0.95
30 mg Intranasal Ketamine	0	± 0
50 mg Intranasal Ketamine	0	± 0

Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Change in Vision Score Primary · Baseline, Minutes 30, 60, and 240, during Study Visits 1 through 4, up to 4 weeks

To evaluate self-reported change in vision, participants completed the Side Effect Rating Scale for Dissociative Anesthetics (SERSDA). During visits 1 through 4, side effects were documented by SERSDA prior to administration of medication and 30, 60 and 240 minutes after ketamine administration. Participants indicated the severity of this side effect by selecting 0 (side effect is absent), 1 (weak side effect), 2 (modest side effect), 3 (bothersome side effect), or 4 (side effect is very bothersome).

Baseline

Group	Value	95% CI
10 mg Intranasal Ketamine	0.4	± 0.70
10 mg Intravenous (IV) Ketamine	0.1	± 0.32
30 mg Intranasal Ketamine	0.1	± 0.32
50 mg Intranasal Ketamine	0	± 0

Minute 30

Group	Value	95% CI
10 mg Intranasal Ketamine	0.1	± 0.32
10 mg Intravenous (IV) Ketamine	0.5	± 0.85
30 mg Intranasal Ketamine	0.1	± 0.32
50 mg Intranasal Ketamine	0.1	± 0.21

Minute 60

Group	Value	95% CI
10 mg Intranasal Ketamine	0	± 0
10 mg Intravenous (IV) Ketamine	0.1	± 0.32
30 mg Intranasal Ketamine	0	± 0
50 mg Intranasal Ketamine	0.1	± 0.32

Minute 240

Group	Value	95% CI
10 mg Intranasal Ketamine	0	± 0
10 mg Intravenous (IV) Ketamine	0	± 0
30 mg Intranasal Ketamine	0	± 0
50 mg Intranasal Ketamine	0	± 0

Adverse events — posted to ClinicalTrials.gov

Time frame: Data collection for adverse events began at the first study visit and were followed by a telephone call 14 days after the last dose of study medication administration, up to 6 weeks.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

10 mg Intranasal Ketamine

Serious: 0/10 (0%)

Deaths: 0/10

10 mg Intravenous (IV) Ketamine

Serious: 1/10 (10%)

Deaths: 0/10

30 mg Intranasal Ketamine

Serious: 0/10 (0%)

Deaths: 0/10

50 mg Intranasal Ketamine

Serious: 2/10 (20%)

Deaths: 0/10

Follow-up Visit

Serious: 0/10 (0%)

Deaths: 0/10

Phone Call 14 Days Post-Last Dose

Serious: 0/10 (0%)

Deaths: 0/10

Serious adverse events (4 terms)

Reaction	System	10 mg Intranasal Ketamine	10 mg Intravenous (IV) Ket…	30 mg Intranasal Ketamine	50 mg Intranasal Ketamine	Follow-up Visit	Phone Call 14 Days Post-La…
Abdominal pain	General disorders	—	—	—	—	—	—
Non-cardiac chest pain	General disorders	—	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—	—
Neck tumor swelling	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—

Other adverse events (41 terms — click to expand)

Reaction	System	10 mg Intranasal Ketamine	10 mg Intravenous (IV) Ket…	30 mg Intranasal Ketamine	50 mg Intranasal Ketamine	Follow-up Visit	Phone Call 14 Days Post-La…
Dizziness	General disorders	—	—	—	—	—	—
Feeling of unreality	General disorders	—	—	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—	—	—
Nausea	General disorders	—	—	—	—	—	—
Drowsiness	General disorders	—	—	—	—	—	—
Anxiety	Psychiatric disorders	—	—	—	—	—	—
Blurry vision	Eye disorders	—	—	—	—	—	—
Change in hearing	Ear and labyrinth disorders	—	—	—	—	—	—
Diarrhea	Gastrointestinal disorders	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—
Headache	General disorders	—	—	—	—	—	—
Hypotension	Vascular disorders	—	—	—	—	—	—
Mood change	Psychiatric disorders	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—
Agitation	Psychiatric disorders	—	—	—	—	—	—
Burning sensation in nostril	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
Bradycardia	Cardiac disorders	—	—	—	—	—	—
Change in sense of smell	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
Confusion	Psychiatric disorders	—	—	—	—	—	—
Dehydration	General disorders	—	—	—	—	—	—
Diaphoresis	Nervous system disorders	—	—	—	—	—	—
Euphoria	General disorders	—	—	—	—	—	—
Facial numbnes	Nervous system disorders	—	—	—	—	—	—
Facial warmth	General disorders	—	—	—	—	—	—
Floating sensation	General disorders	—	—	—	—	—	—
Foul taste	General disorders	—	—	—	—	—	—
Fuzzy thinking	General disorders	—	—	—	—	—	—
In touch with emotions	General disorders	—	—	—	—	—	—
Night sweats	Nervous system disorders	—	—	—	—	—	—
Nightmares	General disorders	—	—	—	—	—	—
Restlessness	General disorders	—	—	—	—	—	—
Sinus tachycardia	Cardiac disorders	—	—	—	—	—	—
Somnolence	General disorders	—	—	—	—	—	—
Tongue numbness	Nervous system disorders	—	—	—	—	—	—
Vertigo	General disorders	—	—	—	—	—	—
Vision changes	Eye disorders	—	—	—	—	—	—
Visual hallucination	General disorders	—	—	—	—	—	—
Intermittent nose bleeds	Skin and subcutaneous tissue disorders	—	—	—	—	—	—
Urinary retention	Renal and urinary disorders	—	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—	—

Most-reported serious reactions: Abdominal pain, Non-cardiac chest pain, Pneumonia, Neck tumor swelling.

Data from ClinicalTrials.gov NCT03146806 adverse events section.

Sponsor's own description

The main purpose of this study is to determine the safety, feasibility, and utility of intranasal (NAS) ketamine in persistent uncontrolled cancer related pain. In this prospective clinical trial the researchers will investigate the use of NAS ketamine in patients with pain related to cancer or cancer treatment. The researchers plan to enroll at least 25 patients meeting inclusion/exclusion criteria, to achieve a minimum of 10 patients who complete the study. Participants will be recruited from the supportive oncology clinic, oncology clinics, the pain clinic and Acute Pain Service at Emory. Participants will be asked to return to the Phase I unit of the Winship Cancer Building C for a total of 5 study visits, each two to five days apart. During these visits participants will complete questionnaires, have blood samples drawn and will have study medication administered to them in escalating doses. For safety monitoring participants will be contacted by telephone 14 days after the last dose of medication administered.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Repurposing Potential of Ketamine: Opportunities and Challenges.
Gautam CS, Mahajan SS, Sharma J, Singh H, et al · · 2020 · cited 19× · PMID 31997862 · DOI 10.4103/ijpsym.ijpsym_228_19
A dose-escalation clinical trial of intranasal ketamine for uncontrolled cancer-related pain.
Singh V, Gillespie TW, Lane O, Spektor B, et al · · 2022 · cited 6× · PMID 35146776 · DOI 10.1002/phar.2669
Efficacy and safety of ketamine for the treatment of depressive symptoms in palliative care: A systematic review.
Barbosa MG, Garcia GT, Sarin LM, Jackowski AP. · · 2023 · cited 5× · PMID 36574497 · DOI 10.47626/1516-4446-2022-2876
Safety of Intranasal Ketamine for Reducing Uncontrolled Cancer-Related Pain: Protocol of a Phase I/II Clinical Trial.
Shteamer JW, Harvey RD, Spektor B, Curseen K, et al · · 2019 · cited 2× · PMID 31038469 · DOI 10.2196/12125

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03146806 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Emory University
Last refreshed: 9 September 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03146806.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT03146806

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (4 terms)

Sponsor's own description

Publications & conference data

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