Hi. This is Dr. Heinzerling, Medical Director of UCLA SARx and the topic of this entry is the first step in the clinical testing of potential medications for methamphetamine addiction: Phase I clinical trials. When we begin testing a potential medication as a treatment for meth addiction, the first thing that must be assessed is whether the medication is safe and tolerable in patients with meth addiction. In particular, there is always the concern that a medication we might want to use to treat meth addiction may inadvertently cause side effects that could be dangerous. A particular issue in meth addiction is if the medication increases the effect of meth on the heart. Meth alone causes an increase in pulse and blood pressure. If the medication we are testing interacts with meth such that the increase in pulse and/or blood pressure is GREATER with the combo of the medication plus meth than it is with meth alone, then this could be dangerous as patients in the clinic will likely use meth on top of the medication before they are able to completely quit.
To find out if a medication is likely to be safe, we have volunteers who use meth go into the hospital (in our case at Harbor-UCLA) where we can observe them very closely. We then have them take the medication and give them small doses of pharmaceutical methamphetamine. We monitor them very closely for any possible side effects and of course treat any possible complications. We also ask them how it feels to get the dose of meth on the medication compared to on a placebo pill to see if the medication might reduce the effects of meth as this could signal it will help in treating meth addiction. If all goes well, the patients tolerate the medication in combo with a low dose of meth and we are able to move the medication to the next step in development: phase II clinical trials (more on this in another posting soon!).
These types of studies are very important in order to learn how patients who use meth react to a new medication. It is not possible to test a medication in the clinic before completing this type of safety study in the hospital. These studies also require that the patients stay in the hospital for a significant amount of time and as a result, participants are compensated for their time commitment. These studies are NOT appropriate for people who want to quit meth as the study does not provide treatment to quit meth, only to see how people who use meth tolerate the mew medication. Anyone who is interested in participating in one of these studies or would like additional info can check out the clinical trials section of the website or call 866-449-UCLA and talk to one of our representatives.
As usual let us know if you have questions or comments either on the website or via out Twitter feed (UCLASARx). Thanks for tuning in.
Tags:
clinical trial,
crystal meth,
harbor-ucla,
keith heinzerling,
medication safety,
phase 1
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