indication
Appetite Stimulation1

MARINOL Capsules are indicated for anorexia associated with weight loss in patients with AIDS.

Clinical trials

Appetite Stimulation in AIDS-Related Anorexia With Weight Loss:

  • A randomized, double-blind, placebo-controlled study involved 139 patients.
  • The initial dosage of MARINOL Capsules in all patients was 5 mg/day, administered as 2.5 mg one hour before lunch and one hour before supper.
  • The effect of MARINOL Capsules on appetite, weight, mood, and nausea was measured at scheduled intervals during the 6-week treatment period.

Results:

Of the 112 patients who completed at least 2 visits in the trial, 99 patients had appetite data at 4 weeks (MARINOL n=50, placebo n=49) and 91 patients had appetite data at 6 weeks (MARINOL n=46, placebo n=45).

A statistically significant difference between MARINOL Capsules and placebo was seen in appetite as measured by the visual analog scale at Weeks 4 and 6 (see figure). Trends toward improved body weight and mood, and decreases in nausea were also seen.

 

Mean Appetite Change From Baseline
Mean Appetite Change From Baseline

After completing the 6-week study, patients were allowed to continue treatment with MARINOL Capsules in an open-label study, in which there was a sustained improvement in appetite.

Side Effects:

Side effects (feeling high, dizziness, confusion, somnolence) occurred in 13 of 72 patients (18%) at this dosage level and the dosage was reduced to 2.5 mg/day, administered as a single dose at supper or bed time.