BridgeMD
New treatment option for Misuse, Opioid
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
What this study is testing
What is Olanzapine?
Olanzapine is an investigational medicine, given as an once-daily, being studied as a potential treatment for misuse, opioid.
Also referred to as Zypreza.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To learn about the effectiveness of taking the antipsychotic medication olanzapine to help lower opioid craving.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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)
You likely can't join 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...
- History of uncontrolled Diabetes Mellitus or hyperglycemia (fasting ≥ 200 mg/dL) within the past month
See the full eligibility criteria
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.