A RANDOMIZED DOUBLE-BLIND TRIAL, USING A SINGLE-BLIND RUN-IN TO ASSESS WITHDRAWAL SYMPTOMS AFTER PROLONGED TREATMENT WITH CANNABIDIOL (GWP42003-P)

A RANDOMIZED DOUBLE-BLIND TRIAL, USING A SINGLE-BLIND RUN-IN TO ASSESS WITHDRAWAL SYMPTOMS AFTER PROLONGED TREATMENT WITH CANNABIDIOL (GWP42003-P) - Cannabidiol (GWP42003-P) withdrawal trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42668

Enrollment

Registered

2015-10-20

Start date

2015-11-17

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

epilepsy

Interventions

During the study GWP42003-P or placebo will be administered twice daily for a total of 42 days.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - healthy male/ female subjects - 18-45 yrs, inclusive - BMI: 18.0-28.0 kg/m2, inclusive

Exclusion criteria

Exclusion criteria: Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood (for men) / 1.0 liters of blood (for women) in the 10 months prior the start of this study.

Design outcomes

Primary

Measure	Time frame
To assess the occurrence of withdrawal symptoms induced by GWP42003-P using: - cannabis withdrawal scale - penn physician withdrawal checklist	—

Secondary

Measure	Time frame
The safety and tolerability of GWP42003-P will be assessed with respect to: - adverse events - vital signs - ECG - Clinical laboratory parameters - physical examination - C-SSRS - NRS - ESS - C-SSRS - HAM-D	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)