87 Participants Needed

Olanzapine for Opioid Use Disorder

JA
Overseen ByJoseph Arthur, MD
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

If you are currently taking any antipsychotic medications, you will need to stop them to participate in this trial. The protocol does not specify about other medications, so it's best to discuss your current medications with the study team.

What data supports the effectiveness of the drug olanzapine for opioid use disorder?

A study found that olanzapine helped heroin-dependent patients with schizophrenia spectrum disorders stay in treatment longer compared to another antipsychotic, suggesting it may help with retention in treatment for those with opioid use disorder.12345

Is olanzapine safe for humans?

Olanzapine is generally considered safe for humans, but it can cause side effects like weight gain, sleepiness, and increased liver enzymes. Rarely, it may lead to serious conditions like diabetic ketoacidosis (a severe diabetes complication) and has been associated with minimal movement disorders. Active monitoring is recommended during treatment.26789

How does the drug olanzapine differ from other treatments for opioid use disorder?

Olanzapine is unique because it is an atypical antipsychotic that can block multiple receptors in the brain, potentially reducing the rewarding effects of opioids like morphine. This makes it different from traditional opioid treatments, which often focus on substituting or blocking opioid receptors directly.1561011

What is the purpose of this trial?

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

Research Team

JA

Joseph Arthur, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

I have been on opioid pain medication for 30 days or more.
Active use of opioids within the past 7 days
Opioid misuse behavior (COMM score ≥ 9/68)
See 4 more

Exclusion Criteria

History of formal psychiatric diagnoses (e.g. bipolar disorder, schizophrenia, major depressive disorder, or anorexia nervosa)
I am allergic to or cannot take olanzapine.
I am currently taking antipsychotic medication.
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either olanzapine or placebo for 4 weeks to assess its effect on opioid craving and misuse

4 weeks
Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

48 weeks
Monthly visits (in-person)

Treatment Details

Interventions

  • Olanzapine
Trial Overview 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.
Participant Groups
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

Findings from Research

In a randomized, double-blind, placebo-controlled trial involving 48 cocaine-dependent individuals over 16 weeks, olanzapine did not show any significant efficacy compared to placebo in reducing cocaine use, as measured by weekly urine screens.
Both groups reported side effects, but there were no unexpected adverse effects, indicating that while olanzapine was safe, it was ineffective for treating cocaine dependence.
Olanzapine in cocaine dependence: a double-blind, placebo-controlled trial.Hamilton, JD., Nguyen, QX., Gerber, RM., et al.[2018]
In a study of 92 adults on methadone treatment, 30% reported a lifetime history of non-medical use (NMU) of olanzapine, primarily for self-medication to relieve anxiety and aid sleep, with some using it for recreational purposes.
A small percentage (12%) reported NMU in the past month, and among those assessed, 50% were identified as high-risk users, indicating a need for healthcare providers to be vigilant about the potential for NMU in patients with addiction histories.
Non-medical use of olanzapine by people on methadone treatment.James, PD., Fida, AS., Konovalov, P., et al.[2023]
In a 7-week trial involving 60 treatment-resistant schizophrenia patients, those with a history of substance abuse showed similar overall improvement in symptoms when treated with olanzapine compared to those without a history of abuse.
Despite a higher tendency for tardive dyskinesia in substance-abusing patients, olanzapine treatment did not lead to increased adverse effects, suggesting it is a safe and effective option for this population.
Olanzapine response in treatment-refractory schizophrenic patients with a history of substance abuse.Conley, RR., Kelly, DL., Gale, EA.[2019]

References

Olanzapine in cocaine dependence: a double-blind, placebo-controlled trial. [2018]
Non-medical use of olanzapine by people on methadone treatment. [2023]
Olanzapine response in treatment-refractory schizophrenic patients with a history of substance abuse. [2019]
[Olanzapine efficacy in the treatment of cocaine abuse in methadone maintenance patients. Interaction with plasma levels]. [2018]
Combination of olanzapine with opioid-agonists in the treatment of heroin-addicted patients affected by comorbid schizophrenia spectrum disorders. [2019]
Olanzapine. Keep an eye on this neuroleptic. [2022]
Safety of olanzapine. [2018]
Diabetic ketoacidosis associated with olanzapine in an adolescent patient. [2018]
Olanzapine - relapse prevention following mania. [2018]
10.United Statespubmed.ncbi.nlm.nih.gov
Bioequivalence of Olanzapine Given in Combination With Samidorphan as a Bilayer Tablet (ALKS 3831) Compared With Olanzapine-Alone Tablets: Results From a Randomized, Crossover Relative Bioavailability Study. [2020]
11.United Statespubmed.ncbi.nlm.nih.gov
Olanzapine suppresses the rewarding and discriminative stimulus effects induced by morphine. [2018]
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