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Recruiting NCT06200181

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

Phase III Interventional Misuse, Opioid

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Olanzapine, Olanzapine, Placebo.
Who it may be relevant to
Registry conditions: Misuse, Opioid. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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)

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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • MD Anderson Cancer Center — Houston

Identifiers

NCT: NCT06200181 · 2023-0492 · NCI-2023-11092

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗