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

M.D. Anderson Cancer Center

Status and phase: Enrolling; Phase 3

Conditions: Misuse, Opioid

Treatments: Drug: Olanzapine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06200181

2023-0492

NCI-2023-11092 (Other Identifier)

Details and patient eligibility

About

To learn about the effectiveness of taking the antipsychotic medication olanzapine to help lower opioid craving.

Full 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)

Enrollment: 87 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18 years or older
2. Diagnosis of head and neck cancer
3. Receiving chronic opioid therapy (≥ 30 days)
4. Active use of opioids within the past 7 days
5. Opioid misuse behavior (COMM score ≥ 9/68)
6. ECOG performance status ≥ 2/4
7. Ability to communicate in English
8. 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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87 participants in 3 patient groups, including a placebo group

Arm 1

Experimental group

Description:

Participants will take a lower dose of olanzapine every day for Days 1-7 and then a higher dose every day for the next 3 weeks

Treatment:

Drug: Olanzapine

Drug: Olanzapine

Arm 2

Experimental group

Description:

Participants will take the lower dose of olanzapine every day for 4 weeks.

Treatment:

Drug: Olanzapine

Drug: Olanzapine

Arm 3

Placebo Comparator group

Description:

Participants will take a placebo every day for 4 weeks.

Treatment:

Drug: Placebo