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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT06200181
Phase
PHASE3
Status
Recruiting
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Conditions

  • Misuse, Opioid

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Olanzapine — DRUG
    Given by PO
  • Olanzapine — DRUG
    Given by PO
  • Placebo — DRUG
    Given by PO

Study Details

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

Key Dates

Start date
Apr 2, 2024
Status verified
May 2026
Primary completion
Nov 1, 2026
Completion
Nov 1, 2026

Study Design

Enrollment
87 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Arm 1
    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
  • Experimental: Arm 2
    Participants will take the lower dose of olanzapine every day for 4 weeks.
  • Placebo Comparator: Arm 3
    Participants will take a placebo every day for 4 weeks.

Primary Outcome Measure

Safety and adverse events (AEs [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030
Joseph Arthur, MD
[email protected]
713-794-1649
Joseph Arthur, MD (PRINCIPAL_INVESTIGATOR)

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MD Anderson Cancer Center· Houston, TX