In Vivo Interaction Study
Effect of naltrexone on THC concentration
No Effect (based on bioequivalence limits) was detected.
Table 2. Cmax of control at t = 240 min; Cmax of test at t = 120 min. P value significance extrapolated from statement within the text: "Table 2, which portrays plasma levels of D9-THC and the metabolite THC-C as a function of naltrexone dose, demonstrates that naltrexone had no significant effect on plasma levels of either compound."
|Compound measured||Measurement||Value||Study sequence||Additional information||N replicates|
(Table 1, Study 2b)
Regular marijuana use
Black or African American
Hispanic or Latino
African American: 3
Marijuana use (days per week): 5 (2)
Marijuana cigarettes/day: 5 (3)
Cigarette smokers: 7
Cigarettes per day: 12 (9)
(mean ± SD)
0, 30, 60, 120, 180 min
Drug or Natural Product Administration
Pharmacodynamics (PD) & Adverse Events
A subset of participants experienced side effects such as nausea, stomach cramping, vomiting, and headache. Specifically, following placebo naltrexone administration, the only dose condition associated with side effects was methadone (10 mg), in which three of the nine partici- pants experienced one of the above symptoms. Active naltrexone increased the likelihood participants would experience side effects in each condition except metha- done (10 mg). Following active naltrexone administra- tion, two participants had side effects in the 15 mg THC condition, while five experienced side effects in the 30 mg THC condition. Four participants had side effects follow- ing 5 mg methadone, while two had side effects following 10 mg methadone.