RECRUITING

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

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2024-04-02

Study Completion:2026-11-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06200181

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Joseph Arthur, MD

CONTACT

(713) 794-1649

jaarthur@mdanderson.org

Principal Investigator

Joseph Arthur, MD

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

MD Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

Joseph Arthur, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-02

Study Completion Date2026-11-01

Study Record Updates

Study Start Date2024-04-02

Study Completion Date2026-11-01

Terms related to this study

Additional Relevant MeSH Terms

Misuse, Opioid