Mean THC Plasma Concentration with High Ethanol CSV JSON

In Vivo Interaction Study

Mean THC Plasma Concentration with High Ethanol

No Effect (based on bioequivalence limits) was detected.

ethanol

Figure 2

Results

Values converted from minutes. 
Original values:

  • Time to peak (min): 5.8 ± 1
  • AUC0-315 (ng*min/mL): 4019 ± 585
Figure 2

Sample Compound measured Value Measurement Study sequence Additional information N replicates

Experimental Conditions

Placebo-controlled
Randomized crossover
Single dosing

Population

Males

6

Limited information is available

Pharmacokinetic (PK) Sampling Information

0, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 360 min

Drug or Natural Product Administration

Object Administration — delta-9-tetrahydrocannabinol (thc)

Inhalation

Cigarette

2.4% THC

Once

Determined by subject

Precipitant Administration — ethanol

Oral

Liquid

2 mL/kg diluted with orange juice to 300 mL

50 mL doses Q 5min

30 min

Natural Product Characteristics

Not specified

Pharmacodynamics (PD) & Adverse Events

Subjective Ratings of Intoxication Utilized a 0-100 scale with use of previous ratings to use for comparison.
 
Physiological Effects Continuous ECG to measure heart rate measured from 60 min before drug administration and for ensuing three hours.

Performance Effects
 Utilized Simulator Evaluation of Drug Impairment instrument with added foor response. Tasked to press a button or foot pedal depending on what value was displayed on a monitor. 

Further information is listed under the Materials and Methods section in the text.

Cardiac disorders 35200000
Psychiatric disorders 36900000

Subjective Ratings of Intoxication "Volunteers were able to consistently differentiate and rate the effects of ethanol from those of marihuana. [...] The mean subjective ratings of marihuana “high” ap- peared to be increased by the prior ingestion of ethanol in a dose-dependent fashion (Fig. 4). However, these in- creases were not statistically significant."

Physiological Effects 
"The results indicate that the administration of placebo ethanol or the two doses of ethanol in combination with the smoking of placebo marihuana induced a modest deceleration of the heart rate over the period of observation. [...] The smoking of THC-containing marihuana markedly accelerated the heart rate."

Performance Effects
"The accuracy of the responses across task components on the SEDI task varied significantly."

More information can be found under the Results section of the text.