NCT06200181

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 87 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 5.0)

Conditions

• Misuse, Opioid

Interventions

Type	Name	Description
DRUG	Olanzapine	Given by PO
DRUG	Olanzapine	Given by PO
DRUG	Placebo	Given by PO

Timeline

• Start date: 2024-04-02
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2024-01-10
• Last updated: 2026-02-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study