Misuse, OpioidPhase 3NCT06200181
Effect of Olanzapine on Opioid Craving and Misuse Among Patients Receiving Opioids for Cancer-related Pain: A Pilot Double-Blind, Randomized Control Trial
A Phase 3 study testing Olanzapine in people with Misuse, Opioid, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To learn about the effectiveness of taking the antipsychotic medication olanzapine to help lower opioid craving. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Misuse, Opioid
- What is being tested?
- Olanzapine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2024to 1 Nov 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- ECOG performance status ≥ 2/4
- Ability to communicate in English
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
To learn about the effectiveness of taking the antipsychotic medication olanzapine to help lower opioid craving.
Read the 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)
- Conditions
- Misuse, Opioid
- Being tested
- Olanzapine, Placebo
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlanzapineDrug
Also called Zypreza
Given by PO
OlanzapineDrug
Also called Zypreza
Given by PO
PlaceboDrug
Given by PO
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Olanzapine |
| Arm 2 | Experimental | Participants will take the lower dose of olanzapine every day for 4 weeks. Receives: Drug: Olanzapine |
| Arm 3 | Placebo comparator | Participants will take a placebo every day for 4 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start2 Apr 2024
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Misuse, OpioidStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph Arthur, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06200181
- Sponsor's protocol ID
- 2023-0492
- Other IDs
- NCI-2023-11092
- Status last verified
- Nov 2026
- First submitted
- 28 Dec 2023
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06200181
- Acronym / sponsor ID
- 2023-0492
- Conditions
- Misuse, Opioid
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 69 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 2 Apr 2024 (actual)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 10 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: OlanzapineParticipants 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 |
| Arm 2 | Experimental | Drug: OlanzapineParticipants will take the lower dose of olanzapine every day for 4 weeks. |
| Arm 3 | Placebo comparator | Drug: PlaceboParticipants will take a placebo every day for 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OlanzapineAlso: ZyprezaGiven by PO | Drug | Arm 1 |
| OlanzapineAlso: ZyprezaGiven by PO | Drug | Arm 2 |
| PlaceboGiven by PO | Drug | Arm 3 |
Primary outcome
Safety and adverse events (AEs
Time frame: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Arthur, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Olanzapine in people with Misuse, Opioid, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and adverse events (AEs (time frame: Through study completion; an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.