Using olanzapine to reduce opioid cravings in cancer patients

Effect of Olanzapine on Opioid Craving and Misuse Among Patients Receiving Opioids for Cancer-related Pain: A Pilot Double-Blind, Randomized Control Trial

This study is testing if the medication olanzapine can help cancer patients reduce their cravings for opioids while they are using them for pain relief.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 87 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: M.D. Anderson Cancer Center (Academic / other)
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT06200181 on ClinicalTrials.gov

What this trial studies

This pilot trial investigates the effectiveness of olanzapine, an antipsychotic medication, in reducing opioid cravings and misuse among patients receiving opioids for cancer-related pain. The study employs a double-blind, randomized control design, comparing olanzapine to a placebo. Primary outcomes include changes in opioid craving and misuse as measured by specific scales, while secondary outcomes assess opioid use, pain intensity, and overall symptom burden. The trial aims to provide insights into the potential role of olanzapine in managing opioid-related issues in this patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with cancer pain who are currently receiving long-term opioid therapy and exhibit opioid misuse behaviors.

Not a fit: Patients with a history of substance use disorders or psychiatric diagnoses may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could help reduce opioid cravings and misuse, improving the quality of life for cancer patients managing pain.

How similar studies have performed: While the use of olanzapine for opioid craving is novel, similar studies exploring antipsychotics for addiction have shown promise.

Eligibility criteria

Inclusion Criteria:

1. Age 18 years or older
2. Diagnosis of cancer pain
3. Receiving long-term opioid therapy (≥ 7 days)32
4. Active use of opioids within the past 7 days
5. Opioid misuse behavior (COMM score ≥ 9/68)
6. Seen by a Supportive Care Clinic or Pain Clinic clinician
7. ECOG performance status ≥ 2/4
8. Ability to communicate in English
9. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

1. Contraindications to, or allergic to, olanzapine
2. Current use of any antipsychotic medication (e.g. quetiapine, haloperidol, risperidone, etc.)
3. History of OUD or other substance use disorders, except marijuana
4. History of formal psychiatric diagnoses (e.g. bipolar disorder, schizophrenia, major depressive disorder, or anorexia nervosa)
5. 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
6. History of uncontrolled Diabetes Mellitus or hyperglycemia (fasting ≥ 200 mg/dL) within the past month
7. History of seizure disorder or neuroleptic malignant syndrome
8. History of cardiac disease (e.g. coronary artery disease, congestive heart failure)
9. (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 this trial is running

Houston, Texas

• MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Joseph Arthur, MD — M.D. Anderson Cancer Center
• Study coordinator: Joseph Arthur, MD

Conditions Misuse, Opioid