Randomized Placebo-Controlled Crossover Trial with Delta 9-Tetrahydrocannabinol (THC) for the Treatment of Cramps in Amyotrophic Lateral Sclerosis

Hypothesis:
The purpose of this study is to investigate the efficacy of THC in the treatment of cramps. It is hypothesized that severity of cramps will improve significantly in patients treated with THC compared to treatment with placebo.

Aim:
To determine the tolerability, safety and efficacy of Delta 9- tetrahydrocannabinol (THC) in the treatment of cramps in ALS.  THC is administered in a pill form.

Status:
Study began July 15, 2004. The study will be 8 weeks in duration for each participant.  It is anticipated that 24 patients will participate.  The entire study period is 18 months.