Anyone going into the addiction counseling field should know something about the medications that are used in medical detoxification, as well as to stabilize active addiction and assist the recovery process. Even though therapists don’t participate directly in the medical aspects of the detoxification and treatment processes, it is helpful to know generally what physicians do, and how we do it. It is also important to understand the roles that medication can play in facilitating recovery. Medications have two names: a brand name given by the company that develops, patents, and first brings them to the market, and a generic name based on their chemical composition. Some medications are known more for their proprietary or brand name and others for their chemical or generic name. For example, Motrin is a brand name for the medication ibuprophen (the generic or chemical name). Tylenol is a brand name for acetaminophen. The “branding” of all kinds of products is a well-known marketing strategy. Corporations want consumers to think of the specific products they make when making purchasing decisions. When refrigerators first came out, one of the major brands was Frigidaire. My grandmother used to say, “The lettuce is in the Frigidaire,” even though she knew we had a Kelvinator. Similarly, any kind of tissue is sometimes called a Kleenex, and any type of copier a xerox. In order for medications to be approved for specific uses, their efficacy for those uses has to be demonstrated through rigorous scientific research. Double-blind, placebo-controlled studies are the gold standard in medical research. Double-blind controlled studies are structured as follows: Let’s use a new acne medication as an example. In our example study, there are one hundred participants with serious acne. These participants are randomly assigned to one of two groups of fifty: one group will receive the new medication that claims to cure acne, and the other group will get sugar pills. The sugar pill is a placebo—an inert or innocuous substance used in controlled experiments to test the efficacy of another substance (in this case, the new acne medication). Neither the patients nor the researchers conducting the study know which patients are getting the actual medication and which are receiving the sugar pill. And at the end of thirty days or for however long the study is scheduled to run, all of the participants are examined to see whose acne got better and whose did not. If significantly more of those receiving the new medication got better compared to those who got the placebo, the medication is considered to be effective. There is also a series of statistical analyses conducted to ensure that such results are not a function of coincidence. That’s a double-blind controlled study. Afterward, in order to get Food and Drug Administration (FDA) approval, the manufacturing drug company has to demonstrate multiple different experiments from multiple different populations that show the medication worked better than the placebo. Given the increasing popular interest in “natural” remedies such as supplements and herbs, it’s vital to be aware that the vitamin/nutritional supplement/natural-homeopathic health industry doesn’t have anywhere near the same level of regulation as medications prescribed by doctors, which is why you regularly see ads for so-called “natural supplements” when you watch TV. Buy this pill because it’s a natural cure for erectile dysfunction or will help regrow hair. This pill will “support your immune system,” whatever that means; this pill “supports your vision,” whatever that means; this pill does this, and this pill does that. At the end of the ad, after they show all these happy people and they’re all wonderful and healthy, the bottom of the screen says, These claims have not been medically reviewed by the Food and Drug Administration. This is an extremely important distinction, especially given the increasing interest among professionals, as well as the general public, in natural remedies and the proliferation of supplements and other similar products. The bottom line is the drug companies have to prove that their medications are safe and effective, but the health food industry only has to show that they’re not going to hurt anybody. And even those products get recalled from time to time. If you are interested in this, go online to the FDA “watch list” and they’ll send you a free e-mail every month about all the things that they’ve recalled. And they recall a lot of health-related products. Herbal supplements are pulled off the market all the time because they’re causing liver abnormalities and other health problems. But, again, they’re officially under the jurisdiction of the Department of Agriculture and not the FDA, so all the manufacturer has to prove is that their products are not likely to be harmful. It is not uncommon for physicians to write prescriptions for medication for what we call “off-label” uses. Off-label means that the medication is prescribed for a use for which it has not necessarily been researched or approved. However, once the FDA approves a drug, its use becomes legal and a physician can prescribe it for any purpose whatsoever. So if I want to prescribe acamprosate, which is an antidrinking medication, to treat a patient’s hemorrhoids, I am legally permitted to do that. There’s no evidence that it works for hemorrhoids and if that patient had a really bad side effect, he or she could probably sue me. And if the case went to trial, it would probably make an idiot out of me publicly because there is no community standard where any doctor uses this medicine for hemorrhoids. Nevertheless, because they can, a lot of doctors will prescribe medications off-label. As physicians, we always start with the medications already approved for addiction treatment by the FDA before we move on to others. However, until recently, very few FDA-approved addiction treatment medications were available. So addiction doctors tried using a number of existing medications off-label and found that many of them worked. An excellent example is clonidine. Though FDA-approved as a blood pressure medication, clonidine is often used in detox to help quell acute withdrawal symptoms. Other medications that are sometimes used off-label to help ease acute withdrawal symptoms include Lioresal (baclofen), Serzone, (nefazodone), and Zofran (ondansetron). Previously, pharmaceutical companies made a cost-benefit determination that there wasn’t enough money to be made in developing medications for addiction treatment purposes. This decision may have been influenced by the fact that in America, we didn’t think of addiction as a disease as much as a moral problem, a bad choice, and a criminal offense. If addiction isn’t a medical issue, what’s the point of working todevelop medications that might aid in its treatment? The changing view of addiction, its unequivocal recognition as a disease, and the medicalization of its treatment, in combination with greater (and even national) health insurance coverage and reimbursement have dramatically changed this situation. This notwithstanding, off-label prescribing in addiction treatment will likely continue, because sometimes pharmaceutical companies prefer not to petition the FDA and invest money in the extensive research necessary for approval. This blog post is an excerpt from The therapist’s Guide to Addiction Medicine – A Handbook for Addiction Counselors and Therapists – by Barry Solof, MD, FASAM; Published by Central Recovery Press (CRP).