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Safety and Pharmacokinetics of Smoked Cannabis in Healthy Patients

NCT04314804 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2020-03-25

No results posted yet for this study

Summary

No actual human data for pharmacokinetics, metabolism, safety, pharmacodynamics, nor efficacy parameters are available for inhaled medical cannabis. This study was designed to investigate the innocuity and tolerability levels as well as the pharmacokinetic profile of this combination when smoked/inhaled as intended in clinical therapeutic use (i.e. patients with neuropathic pain). Consecutive dosing (over a period of 7 days) should allow to test the tolerability of chronic administration. In addition, the impact of the THC/cannabidiol pharmacological activity on the cognition activity, cognitive test will be performed before and throughout the treatment and compared to the plasma levels of THC/cannabidiol following single and multiple dosing.

Conditions

  • Healthy Volunteers

Interventions

COMBINATION_PRODUCT

PPP001

1 pellet smoked up to 3 times a day with titanium pipe (280 mg dried cannabis pellet - 9% THC / 2% CBD per pellet)

COMBINATION_PRODUCT

Placebo

1 pellet smoked up to 3 times a day with titanium pipe (280 mg dried cannabis pellet - 0% THC / 0.6% CBD per pellet)

Sponsors & Collaborators

  • Tetra Bio-Pharma

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-01
Primary Completion
2017-11-08
Completion
2017-11-16

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04314804 on ClinicalTrials.gov