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A randomized, double-blind, placebo-controlled 2-way crossover study to assess the analgesic effects of THC in patients with chronic neuropathic pain and to phenotype the responders to THC treatment.

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-502343-35-00
Acronym
CHDR2220
Enrollment
200
Registered
2022-12-15
Start date
2024-02-20
Completion date
Unknown
Last updated
2025-10-02

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

Conditions

Chronic neuropathic pain

Brief summary

• Pain severity NRS (measured daily), weekly average, • Experience sampling method (ESM) NRS pain scores

Detailed description

• Sleep quality (Pittsburgh Sleep Quality Index, or PSQI), • Sleep quality (Daily VAS), • Anxiety severity (HADS), • Depression severity (HADS), • Quality of Life questionnaire (SF36), • Drug effects questionnaire (DEQ), including VAS ‘Feeling high’ ‘Drug liking’ and VAS ‘Want more of the drug’, • Trial At Home (T@H) geospatial and phone usage tracking, • Treatment-emergent (serious) adverse events ((S)AEs) throughout the study at every study visit, • Concomitant medication throughout the study at every study visit, • Vital signs (Pulse Rate (bpm), Systolic blood pressure (mmHg), Diastolic blood pressure (mmHg)) as per assessment schedule, • Pain severity NRS (measured daily), weekly average

Interventions

DRUGPlacebo for Clinican THC 2% oil
DRUGClinican THC 2% oil

Sponsors

Centre For Human Drug Research
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
• Pain severity NRS (measured daily), weekly average, • Experience sampling method (ESM) NRS pain scores

Secondary

MeasureTime frame
• Sleep quality (Pittsburgh Sleep Quality Index, or PSQI), • Sleep quality (Daily VAS), • Anxiety severity (HADS), • Depression severity (HADS), • Quality of Life questionnaire (SF36), • Drug effects questionnaire (DEQ), including VAS ‘Feeling high’ ‘Drug liking’ and VAS ‘Want more of the drug’, • Trial At Home (T@H) geospatial and phone usage tracking, • Treatment-emergent (serious) adverse events ((S)AEs) throughout the study at every study visit, • Concomitant medication throughout the study at every study visit, • Vital signs (Pulse Rate (bpm), Systolic blood pressure (mmHg), Diastolic blood pressure (mmHg)) as per assessment schedule, • Pain severity NRS (measured daily), weekly average

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026