The effects of inhaled delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) on pain relief and subjective effects in fibromyalgia patients - A placebo controlled PKPD study

Completed

Conditions: chronische pijn
chronic pain
pain

Registration Number: NL-OMON42607

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

Twenty pain patients diagnosed with fibromyalgia will be included if they have a pain score p(on a scale from 0 <= no pain to 10 <= most pain imaginable) for most of the day and meet the 2010 American College of Rheumatology diagnostic criteria.

Exclusion Criteria

i) Unable to give written informed consent; (ii) medical disease such as pulmonary, renal, liver, cardiac, gastro-intestinal, vascular disease; (iii) allergy to study medication; (iv) use of strong opioids; (v) use of benzodiazepines; (vi) history of illicit drug use (incl. cannabis-related products) or alcohol abuse; (vii) (family) history of psychosis; (viii) epilepsy; (ix) raised intracranial pressure;(x) pregnancy and/or lactation; (xi) the presence of pain syndromes other than fibromyalgia.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main end-points: PK data, spontaneous and experimental pain relief.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary end-points: Blood pressure, cardiac output, temperature, mental state<br /><br>(drug high, internal perception, external perception, depression, anxiety,<br /><br>arousal, positive mood, alertness, contentment, calmness), psychomimetic side<br /><br>effects.</p><br>