Effect of naltrexone on THC concentration CSV JSON

In Vivo Interaction Study

Effect of naltrexone on THC concentration

No Effect (based on bioequivalence limits) was detected.

naltrexone

(Table 2)

Results

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

Experimental Conditions

(Table 1, Study 2b)

Fixed-sequence
Placebo-controlled

Population

Healthy volunteers
Males

Regular marijuana use
Smokers

Black or African American
Hispanic or Latino
White

7

African American: 3
Caucasian: 1
Hispanic: 3
Marijuana use (days per week): 5 (2)
Marijuana cigarettes/day: 5 (3)
Cigarette smokers: 7
Cigarettes per day: 12 (9)
(mean ± SD)
(Table 1)

Pharmacokinetic (PK) Sampling Information

0, 30, 60, 120, 180 min

Drug or Natural Product Administration

Object Administration — delta-9-tetrahydrocannabinol (THC)

Oral

Capsule

30 mg

Once

Precipitant Administration — naltrexone

Oral

tablet

50 mg

Once

Natural Product Characteristics

Not specified

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.