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Arm 1 for Addiction

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion; an average of 1 year

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 below

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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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety and adverse events (AEs

Side effects data

From 2008 Phase 4 trial • 25 Patients • NCT00001656

31%

Increased appetite

31%

Hypersalivation

17%

tachycardia >100 beats/min (supine)

15%

Constipation

15%

Somnolence

Hypertension

Difficulty concentrating

Insomnia

Enuresis

Abnormal white blood count

100%

80%

60%

40%

20%

Study treatment Arm

Olanzapine Group

Clozapine Group

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

~5480

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,974 Previous Clinical Trials

1,789,387 Total Patients Enrolled

Joseph Arthur, MDPrincipal InvestigatorM.D. Anderson Cancer Center

1 Previous Clinical Trials

200 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the second arm of this study been granted approval by the FDA?

"Based on the fact that this trial is in Phase 3 and has gathered substantial safety data, our team at Power rates Arm 2 with a safety score of 3."

Answered by AI

Are there ongoing efforts to actively enroll participants in this clinical trial?

"As per the information provided by clinicaltrials.gov, this particular clinical trial is not actively seeking participants. The study was originally posted on June 30th, 2024 and last updated on December 28th, 2023. However, it's worth noting that there are currently 309 other ongoing clinical trials that are actively enrolling patients at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effect of Olanzapine on Opioid Craving and Misuse Among Patients Receiving Opioids for Cancer-related Pain: A Pilot Double-Blind, Randomized Control Trial

2024. "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. https://clinicaltrials.gov/ct2/show/NCT06200181.

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