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

NCT06200181 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: 2023-0492NCI-2023-11092
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Misuse, Opioid

Outcome Measures

Primary Outcomes (1)

• Safety and adverse events (AEs

  Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  Through study completion; an average of 1 year

Study Arms (3)

Arm 1

EXPERIMENTAL

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

Drug: Olanzapine

Arm 2

EXPERIMENTAL

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

Drug: Olanzapine

Arm 3

PLACEBO COMPARATOR

Participants will take a placebo every day for 4 weeks.

Drug: Placebo

Interventions

Olanzapine DRUG

Given by PO

Also known as: Zypreza

Arm 1

Placebo DRUG

Given by PO

Arm 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Olanzapine

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Joseph Arthur, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joseph Arthur, MD

CONTACT

(713) 794-1649; jaarthur@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2023
• First Posted: January 10, 2024
• Study Start: April 2, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Locations

US (1)