A Study On The Efficacy Of Delta-9-Tetrahydrocannabinol (Dronabinol) In Renal Itch

Phase 1

Active, not recruiting

• Conditions: Itch associated with chronic renal failure

• Registration Number: EUCTR2005-000817-37-GB
• Lead Sponsor: Cardiff University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05-27
• Study Completion: 2007-07-05
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

Patients with chronic renal failure treated with continuous ambulatory peritoneal dialysis (CAPD) with a history of pruritis for more than 8 weeks.

Patients with haemoglobin level =11g/dl.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients with concomitant dermatological disease or another metabolic cause of itch.
Patients with history of poor concordance
Patients who are pregnant, planning to conceive or refuse to take adequate precaution to avoid pregnancy
History of psychotic illnesses, schizophrenia, and any other mental illnesses. Mild depression will not be exclude participation but severe depression requiring electroconvulsive therapy (ECT) or inpatient treatment will be excluded
Patients who refuse to abstain from driving during the study
Those with a history of allergy to delta-9-THC or its related compounds or constituents of dronabinol
Patients with unstable cardiac diseases such as uncontrolled hypertension, acute coronary syndrome and uncontrolled arrythmia as delta-9-THC may cause hypo- or hypertension and tachycardia. However, patients with stable cardiac conditions will not be excluded.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified