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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

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 - Spirocan

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON42607
Enrollment
20
Registered
2015-11-12
Start date
2016-05-10
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronische pijn chronic pain pain

Interventions

1. inhalation of cannabis 2. questionnaires (HADS, Bond & Lader, Bowdle, POMS) 3. Blood sampling 4. pain testing 5. Cornea photo (Cornea Confocal Microscopy)

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Twenty pain patients diagnosed with fibromyalgia will be included if they have a pain score p(on a scale from 0

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
Main end-points: PK data, spontaneous and experimental pain relief.

Secondary

MeasureTime frame
Secondary end-points: Blood pressure, cardiac output, temperature, mental state (drug high, internal perception, external perception, depression, anxiety, arousal, positive mood, alertness, contentment, calmness), psychomimetic side effects.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)