To hear about similar clinical trials, please enter your email below
Trial Title:
Effect of Olanzapine on Opioid Craving and Misuse Among Patients Receiving Opioids for Cancer-related Pain: A Pilot Double-Blind, Randomized Control Trial
NCT ID:
NCT06200181
Condition:
Misuse, Opioid
Conditions: Official terms:
Cancer Pain
Opioid-Related Disorders
Olanzapine
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Olanzapine
Description:
Given by PO
Arm group label:
Arm 1
Other name:
Zypreza
Intervention type:
Drug
Intervention name:
Olanzapine
Description:
Given by PO
Arm group label:
Arm 2
Other name:
Zypreza
Intervention type:
Drug
Intervention name:
Placebo
Description:
Given by PO
Arm group label:
Arm 3
Summary:
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)
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Joseph Arthur, MD
Phone:
713-794-1649
Email:
jaarthur@mdanderson.org
Investigator:
Last name:
Joseph Arthur, MD
Email:
Principal Investigator
Start date:
April 2, 2024
Completion date:
November 1, 2026
Lead sponsor:
Agency:
M.D. Anderson Cancer Center
Agency class:
Other
Source:
M.D. Anderson Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06200181
http://www.mdanderson.org
