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

StatusActive, Not Recruiting
PhasePhase 3
Started2024-04-02
View on ClinicalTrials.gov ↗

Amendment history

2026-09-09
Study Status, Study Design, Contacts/Locations v7
Enrollment closed, study ongoing
Final enrollment: 69 participants (planned 87)
Enrollment targetestimated 87→confirmed 69
Study sitesdetails revised at 1 of 1 site
2026-05-28
3 amendments v4-v6
3 re-verifications since 2025-08-05, no change to tracked fields
2024-12-30
Study Status, Eligibility v3
Eligibility criteria+52 characters
Inclusion Criteria: Age 18 years or older Diagnosis of headcancer and neck cancerpain Receiving chroniclong-term opioid therapy (≥ 307 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 Engl [...]
2024-07-03
Study Status v2
Re-verified, no change to tracked fields
2024-04-02
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-06-30→confirmed 2024-04-02
Study sitesdetails revised at 1 of 1 site
2023-12-28
Original filing
To learn about the effectiveness of taking the antipsychotic medication olanzapine to help lower opioid craving.
Trial Details
NCT Number NCT06200181
Lead Sponsor M.D. Anderson Cancer Center
Conditions Misuse, Opioid
Enrollment 69 participants
Start Date 2024-04-02
Primary Completion 2026-11-01 (estimated)
Study Completion 2026-11-01 (estimated)
Updated on ClinicalTrials.gov 2026-09-10