Plasma CBD Concentrations CSV JSON

In Vivo Interaction Study

Plasma CBD Concentrations

No Effect (based on bioequivalence limits) was detected.

fentanyl

cannabidiol (cbd)

(Figure 2)

Results

Value reported estimated at 3 hours with 800 mg CBD (original value reported = ~170 µg/L)
With 400 mg CBD, Cmax mean ± SEM ~ 140 µg/L ± 20 µg/L
Values above converted to ng/mL.
CBD+placebo led to 0 µg/Lconcentration throughout the 8 hours collected.
(Figure 2)

Sample Compound measured Value Measurement Study sequence Additional information N replicates

Experimental Conditions

Biphasic with at least one week interim.
(Figure 1)

Double-blind
Placebo-controlled
Randomized crossover

Population

Healthy volunteers

Healthy alcohol drinking
No marijuana use
Nonsmokers
Smokers

12

Healthy volunteers were recruited through advertisement in the community and local newspapers and assigned a unique identification number. Inclusion Criteria: past exposure at least once to an opioid (i.e. codeine, morphine, fentanyl); and aged between 21 and 65 years. Exclusion Criteria: using any psychoactive drug at any time during the study; current diagnosis of drug dependence (except nicotine dependence) based on Structured Clinical Interview for DSM-IV (SCID-IV) interview; history of cardiac disease, arrhythmias, head trauma, seizures, or Axis I psychiatric conditions under DSM-IV examined with the Mini International Neuropsychiatric Interview-MINI; hypersensitivity to any opioid or cannabinoid; pregnant or breastfeeding; not using an appropriate method of contraception; or intoxication at the time of arrival on the site of the study or positive drug screen (screened for cocaine, cannabis, opiates, benzodiazepines, barbiturates, phencyclidine, amphetamines). Subjects were compensated $150 per session and $10 for screening; compensation was determined based on minimum wage, hours required for study participation and transportation fees. We enrolled 6 subjects per study group similar to CBD studies using the same dose range in healthy subjects (Crippa et al., 2004).

Pharmacokinetic (PK) Sampling Information

Blood: -10 min, 30 min, 90 min, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr; Urine: -2 hr, 30 min, 2 hr, 4 hr, 6 hr, 8 hr

Provided standardized meal

Blood and urine: 1 hr, 3 hr, 5 hr, 7 hr post-administration of fentanyl

Provided standardized meal

Drug or Natural Product Administration

Object Administration — fentanyl

Oral

Capsule

400 mg or 800 mg

Once per session, dose dependent on group

Precipitant Administration — cannabidiol (cbd)

Intravenous

Solution

0.5 or 1 mcg/kg

Once per session, dose dependent on group

Natural Product Characteristics

Not provided

Pharmacodynamics (PD) & Adverse Events

Clinical monitoring of vital signs (temperature, heart rate, respiratory rate, blood pressure, oxygen saturation) occurred continuously and was analyzed at time points according to Figure 1 using AUC between groups. 

Cardiac disorders 35200000
Respiratory, thoracic and mediastinal disorders 37200000

There were no occurrences of respiratory depression (breaths/min <12) or cardiovascular compromise (mean arterial pressure <60mmHg, heart rate >100) in any subject at any time point. Higher fentanyl dose (1.0 vs. 0.5 mcg/kg) was associated with slightly lower respiratory rate and temperature (mean AUC t-test p<0.05), however, cardiovascular parameters were similar between sessions (p=NS). CBD dose (0 vs. 400 vs. 800mg) was not associated with any significant differences in vital sign parameters throughout the study (mean AUC ANOVA p=NS for all).

Respiratory, thoracic and mediastinal disorders 37200000