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3. Umbruch 4.4..2005 - Online Pot

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The development of Sativex ® – a natural cannabis-based medicine 257<br />

Figure 10. Intoxication produced by Sativex ® [58]. BL, baseline; DB, randomized, double-blind period<br />

(weeks 1–6). Placebo crossed over to Sativex ® in weeks 7–10. Adapted from Wade et al. [58].<br />

As can be seen from Figure 10, the maximum severity of intoxication experienced<br />

by patients (measured using a VAS) was only approximately 20 out of<br />

100 mm following initial exposure to Sativex ® . This severity occurs early on<br />

in their initial titration period (within the first 2 weeks) and rapidly diminishes<br />

over time to scores less than 5 out of 100 mm. Figure 10 also shows that the<br />

picture is repeated in placebo patients who were then switched over to<br />

Sativex ® . The long-term intoxication data presented in Table 3 also support<br />

this (see also Fig. 11).<br />

So, although a relatively small amount of intoxication may occur initially in<br />

patients who use Sativex ® , it subsides over time, and may be easily managed<br />

using patient self-titration, to minimize levels even further.<br />

Table <strong>3.</strong> Long-term intoxication produced by Sativex ® [64]<br />

Study week No. of Mean VAS SD Median Minimum Maximum<br />

patients score<br />

4 330 4.84 11.69 1 0 75<br />

12 268 <strong>3.</strong>08 8.33 0 0 62<br />

20 211 2.04 4.75 0 0 35<br />

28 205 2.46 6.26 0 0 42<br />

36 184 2.83 6.77 0 0 45<br />

44 150 <strong>3.</strong>69 10.54 0 0 77<br />

52 121 2.26 7.29 0 0 50<br />

60 90 1.37 6.02 0 0 53<br />

68 62 1.92 8.94 0 0 69<br />

VAS scale is 0–100 mm, where 0 means no intoxication and 100 is extreme intoxication.

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