NCT04099355

Brief Summary

This study is designed to investigate the effect of dronabinol on post operative pain in patients undergoing total knee replacement (for their own clinical care).

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
16mo left

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress34%
Sep 2025Aug 2027

First Submitted

Initial submission to the registry

September 19, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 23, 2019

Completed
5.9 years until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2027

Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

2 years

First QC Date

September 19, 2019

Last Update Submit

November 8, 2023

Conditions

Knee ReplacementArthropathy of Knee

Outcome Measures

Primary Outcomes (1)

  • Brief Pain Inventory-Short Form

    pain assessment, self report measure of pain, scale 0-10 (10 worst)

    2 weeks

Secondary Outcomes (1)

  • opioid medication log

    two weeks

Study Arms (2)

dronabinol

EXPERIMENTAL

active group

Drug: Dronabinol 5mg CapDrug: Non-active comparator

control

PLACEBO COMPARATOR

control group

Drug: Dronabinol 5mg CapDrug: Non-active comparator

Interventions

Dronabinol 5mg CapDRUG

1 QAM and 2 QHS PO 14 days

controldronabinol
Non-active comparatorDRUG

1 QAM and 2 QHS PO 14 days

controldronabinol

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants undergoing total knee arthroplasty (TKA) at the CUIMC department of orthopedic surgery as part of their clinical care.
  • Able to give informed consent and comply with study procedures in English

You may not qualify if:

  • Meet DSM-V criteria for current major psychiatric illness, such as bipolar disorder, major depression, or psychosis. Subjects with a current substance use disorder will be excluded. Subjects with a past cannabis use disorder are excluded.
  • Diagnosis of a major medical or neurological disorder, including orthostatic hypertension, cardiovascular disease (congestive heart failure, unstable angina, or a history of cardiac infarction), hypotension, or neurodegenerative disorders.
  • Subjects taking medications that can lead to a drug interaction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1051 Riverside Drive

New York, New York, 10032, United States

Location

MeSH Terms

Interventions

DronabinolCapsules

Intervention Hierarchy (Ancestors)

CannabinoidsTerpenesHydrocarbonsOrganic ChemicalsDosage FormsPharmaceutical Preparations

Study Officials

  • Diana Martinez, MD

    NYSPI

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Psychiatrist II

Study Record Dates

First Submitted

September 19, 2019

First Posted

September 23, 2019

Study Start

September 1, 2025

Primary Completion (Estimated)

August 30, 2027

Study Completion (Estimated)

August 30, 2027

Last Updated

November 13, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)