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Olanzapine for Opioid Use Disorder
Phase 3
Recruiting
Led By Joseph Arthur, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance status ≥ 2/4
Diagnosis of head and neck cancer
Must not have
Contraindications to, or allergic to, olanzapine
Current use of any antipsychotic medication (e.g. quetiapine, haloperidol, risperidone, etc.)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year
Awards & highlights
Pivotal Trial
Summary
This trial aims to see if taking the medication olanzapine can help reduce cravings for opioids.
Who is the study for?
This trial is for patients who are experiencing pain due to cancer and have been prescribed opioids. It's aimed at those who might be struggling with opioid cravings or misuse.
What is being tested?
The study tests if olanzapine, an antipsychotic medication, can reduce the craving for opioids in these patients. Participants will either receive olanzapine or a placebo without knowing which one they get.
What are the potential side effects?
Olanzapine may cause drowsiness, weight gain, increased appetite, dry mouth, restlessness, and sometimes more serious side effects like changes in blood sugar and cholesterol.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I need some help with my daily activities.
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I have been diagnosed with head and neck cancer.
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I have been on opioid pain medication for 30 days or more.
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I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am allergic to or cannot take olanzapine.
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I am currently taking antipsychotic medication.
Select...
I have a history of seizures or neuroleptic malignant syndrome.
Select...
I have a history of heart disease.
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My blood sugar has been stable and below 200 mg/dL in the past month.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion; an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Safety and adverse events (AEs
Side effects data
From 2008 Phase 4 trial • 25 Patients • NCT0000165670%
tachycardia >100 beats/min (supine)
67%
Hypersalivation
64%
Hypertension
42%
Enuresis
33%
Increased appetite
33%
Difficulty concentrating
25%
Insomnia
17%
Abnormal white blood count
17%
Somnolence
17%
Constipation
10%
Tachycardia >120 beats/min (supine)
100%
80%
60%
40%
20%
0%
Study treatment Arm
Clozapine Group
Olanzapine Group
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm 2Experimental Treatment1 Intervention
Participants will take the lower dose of olanzapine every day for 4 weeks.
Group II: Arm 1Experimental Treatment1 Intervention
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
Group III: Arm 3Placebo Group1 Intervention
Participants will take a placebo every day for 4 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olanzapine
2005
Completed Phase 4
~5030
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,074 Previous Clinical Trials
1,803,458 Total Patients Enrolled
Joseph Arthur, MDPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials