Ignite Creation Date:
2024-05-06 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06200181
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2023-12-28
Brief Title:
Effect of Olanzapine on Opioid Craving and Misuse Among Patients Receiving Opioids for Cancer-related Pain A Pilot Double-Blind Randomized Control Trial
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Effect of Olanzapine on Opioid Craving and Misuse Among Patients Receiving Opioids for Cancer-related Pain A Pilot Double-Blind Randomized Control Trial
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To learn about the effectiveness of taking the antipsychotic medication olanzapine to help lower opioid craving
Detailed Description:
Primary Objective To determine the effect of olanzapine on opioid craving among patients receiving opioids for cancer pain Opioid Craving Scale Opioid Craving Visual Analogue Scale change from baseline
Secondary Objective To determine the effect of olanzapine on opioid misuse among patients receiving opioids for cancer pain Current Opioid Misuse Measure change from baseline
Exploratory Objective
To estimate the effect of olanzapine and placebo on the amount of opioid use among patients receiving opioids for cancer pain morphine equivalent daily dose
To determine the effect of olanzapine and placebo on pain intensity among patients receiving opioids for cancer pain Brief Pain Inventory
To determine the effect of olanzapine and placebo on overall symptom burden among patients receiving opioids for cancer pain ESAS symptom Distress Score
To estimate the differences between the olanzapine and placebo effects on opioid craving and misuse measures Opioid Craving Scale Opioid Craving Visual Analogue Scale Current Opioid Misuse Measure
To determine the adverse effects of olanzapine and placebo among patients receiving opioids for cancer pain National Cancer Institute Common Terminology Criteria for Adverse Events version 50
Secondary Objective To determine the effect of olanzapine on opioid misuse among patients receiving opioids for cancer pain Current Opioid Misuse Measure change from baseline
Exploratory Objective
To estimate the effect of olanzapine and placebo on the amount of opioid use among patients receiving opioids for cancer pain morphine equivalent daily dose
To determine the effect of olanzapine and placebo on pain intensity among patients receiving opioids for cancer pain Brief Pain Inventory
To determine the effect of olanzapine and placebo on overall symptom burden among patients receiving opioids for cancer pain ESAS symptom Distress Score
To estimate the differences between the olanzapine and placebo effects on opioid craving and misuse measures Opioid Craving Scale Opioid Craving Visual Analogue Scale Current Opioid Misuse Measure
To determine the adverse effects of olanzapine and placebo among patients receiving opioids for cancer pain National Cancer Institute Common Terminology Criteria for Adverse Events version 50
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2023-11092 | OTHER | NCI-CTRP Clinical Registry | None |