Study identification

EU PAS number

EUPAS107696

Study ID

107697

Official title and acronym

Eine nicht-interventionelle, offene, prospektive Studie zur Beurteilung des Einflusses und der Sicherheit eines ausgewogenen (10mg:10mg) THC/CBD-Extrakts auf die Schlafqualität und Schmerzempfindung bei chronischen Schmerzpatient/innen. (IMprovement of sleep in PAin patients under Cannabis Treatment) (IMPACT)

DARWIN EU® study

No

Study countries

Germany

Study description

Sleep is a physiological process, that has an important role in physical recovery and relaxation and therefore is essential for the maintanance of vital functions. Chronical sleep disturbances, as insomnia and obstructive sleep apnea, are of health risk, as they are associated with depression, cardiovascular diseases and dementia. An association of the Endocannabinoid system with the sleep-wake cycle could be shown in studies for human and animals. Several randomized clinical studies already demonstrated first hints that medical Cannabis or Cannabinoids in comparison to placebo can improve the quality of sleep as well as sleep interruptions in patients with chronical tumour-related and non-tumour-related pain. Similar effects were reported in self-assessments of patients regarding sleep quality, sleep interruptions and falling-asleep duration. However, there are not enough evidences for the use of Cannabinoids as secure and effective routine treatment for sleep disturbances, yet. Encouraging results of newer studies justify further clinical studies to investigate the potential role of Cannabinoids in treatment of sleep disturbances. Thereby, the effect on the quality of sleep and by that on pain intensity of chronic pain patients is of special interest.

Study status

Ongoing

Contact details

Richard Ibrahim

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of final study report

Planned:
Sources of funding
Other
Pharmaceutical company and other private sector 

More details on funding

Avextra Pharma GmbH, Pain Technologies and Clinical Monitoring GmbH
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable