Status:
RECRUITING
Effect of Olanzapine on Opioid Craving and Misuse Among Patients Receiving Opioids for Cancer-related Pain: A Pilot Double-Blind, Randomized Control Trial
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Misuse, Opioid
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 base...
Eligibility Criteria
Inclusion
- Age 18 years or older
- Diagnosis of cancer pain
- Receiving long-term opioid therapy (≥ 7 days)32
- Active use of opioids within the past 7 days
- Opioid misuse behavior (COMM score ≥ 9/68)
- Seen by a Supportive Care Clinic or Pain Clinic clinician
- ECOG performance status ≥ 2/4
- Ability to communicate in English
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion
- Contraindications to, or allergic to, olanzapine
- Current use of any antipsychotic medication (e.g. quetiapine, haloperidol, risperidone, etc.)
- History of OUD or other substance use disorders, except marijuana
- History of formal psychiatric diagnoses (e.g. bipolar disorder, schizophrenia, major depressive disorder, or anorexia nervosa)
- Hepatic insufficiency (defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 3 times the highest normal value, or total bilirubin \>1.5 times the highest normal value) within the past month
- History of uncontrolled Diabetes Mellitus or hyperglycemia (fasting ≥ 200 mg/dL) within the past month
- History of seizure disorder or neuroleptic malignant syndrome
- History of cardiac disease (e.g. coronary artery disease, congestive heart failure)
- (Females only) Known pregnancy, as communicated to study personnel by clinicians; females of childbearing potential will receive advice to use methods of contraception per usual care.
Key Trial Info
Start Date :
April 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT06200181
Start Date
April 2 2024
End Date
November 1 2026
Last Update
August 7 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030