Clinical pilot study to review the impact of perioperative administration of the synthetic cannabinoid nabilone in the context of spinal fusion surgery on the coping with surgery and the pain perception of patients with severely reduced quality of life

Phase 1

• Conditions: Spine disease; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2015-004227-31-AT
• Lead Sponsor: OA Dr. Philipp Becker c/o Abteilung für Wirbelsäulenchirurgie, Orthopädisches Spital Speising GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-04
• Last Update Posted: 29 April 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Written informed consent
• Indication for a spinal fusion surgery
• Suspected availability within the max.120 day period of study participation
• No identification of any exclusion criterion

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 18
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 18

Exclusion Criteria

1) Non-completion of the 18th year of life
2) Detention (for a court or administrative order), accommodation
(under Unterbringungsgesetz) or (already made or in the) appointment
of a trustee
3) Limited contractual capability
4) Military service
5) Pregnancy and not excluded pregnancy (women of childbearing
potential)
6) Risk of the occurrence of pregnancy during the study participation (in
women the absence of at least one of the following criteria: onset of
menopause more than 2 years ago, postmenopausal sterilization,
surgical sterilization, use of a reliable method of contraception for the duration of the study with hormones, intrauterine device (coil) or diaphragm / condom + spermicide)
7) Lactation
8) HADS-Anxiety> 8
9) HADS-Depression> 8
10) Treatment with a cannabinoid or consumption of cannabis or analogous substances within the past 6 months
11) Contraindication for nabilone
12) Start of opioid therapy in the last week
13) (except for the investigational drug:) Foreseeable treatment with cannabinoids or consumption of cannabis or analogous substances during study participation
14) Absolute contraindication for the use of postoperative medication required to be applied (Mexalen®, Tradolan®, Dipidolor® and Zofran
Zydis®)
15) Unsatisfactory treatability of pain resulting from multiple contraindications for the use of analgesics and analgesics classes
16) Foreseeable compliance problems
17) Concomitant disease with the potential for a relevant short-term improvement or worsening of pain and mental state
18) Participation in another study with insurance cover
19) Running processes for early retirement / long-term sick leave
20) (Except for the surgery-related hospitalization:) planned hospital stay within the next four months (incl. stays preceding surgery at other Departments of the Orthopedic Hospital Speising)

Study & Design

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