Cannabis Phase I and II Clinical Trial Design

This pdf document (below) illustrates an easy to implement Phase I and II clinical trial structure to test the analgesic efficacy of cannabis. Using either dried cannabis flower or a cannabis extract, it can be adapted into various formats and delivery methods.

Phase I (Stage 1)

This is a rapid open-label trial that investigates the efficacy of a specific product, in this case extract X. Using 5 subjects one can quickly determine basic analgesic efficacy, as well as other primary physiological parameters such as heart rate, blood pressure, and ECG. A standardized delivery method with the medically verified Volcano Vaporizer is utilized, with vapor administration performed over a 10 minute time frame. One physician can be hired to conduct the trial in 5 patients. If analgesic effects are observed, then one can proceed to stage 2.

Phase II (Stage 2)

Here one can incorporates the gold-standard randomized, placebo-controlled, crossover trial design. To achieve ideal study power, 15 subjects should be recruited for this trial. The 15 subjects should be randomized with proper using adequate randomization software, to a 1:1 ratio. Randomized patients should receive a single exposure of extract X (test sample) or placebo. Following this they would crossover to receive the other treatment, if they first took extract X they would then have the placebo and vice-versa. A 48-hour washout period should be implemented between each treatment to avoid carryover effects.

Inclusion criteria for study patients

The 15 patients should be healthy male or female; 21-50 years; ideally cannabis naive; non-smoking, normal ECG, urine and blood chemistries; normal lung function tests (vital capacity and forced expiratory volume in 1 second). Important written and informed consent.

Exclusion criteria for study patients

Existing drug abuse; use of alcohol, over-the-counter of or prescription (analgesic) medication 24 hours before or during study; pregnancy; and history of psychiatric disorders.

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