NCT06200181 · M.D. Anderson Cancer Center
Effect of Olanzapine on Opioid Craving and Misuse Among Patients Receiving Opioids for Cancer-related Pain: A Pilot Double-Blind, Randomized Control Trial
What this study is about
To learn about the effectiveness of taking the antipsychotic medication olanzapine to help lower opioid craving.
View original scientific description
To learn about the effectiveness of taking the antipsychotic medication olanzapine to help lower opioid craving.
Interventions
DRUG
Olanzapine
Given by PO
DRUG
Olanzapine
Given by PO
DRUG
Placebo
Given by PO
Primary outcome measures
Safety and adverse events (AEs
Time frame: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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.
Where
- Houston, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 1, 2026 · Source of record for eligibility and locations