Clinical Cannabidiol Trials in Fort Worth Texas

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Texas Monthly – February 2016 – By Dan Solomon

How a clinical trial in Fort Worth could lead the FDA to approve medical marijuana for patients who desperately need the drug: Children with debilitating epilepsy.

When the drug arrives at Cook Children’s Medical Center, in Fort Worth, Danelle Morgan, the hospital’s investigational drug service administrator, gets a text message from the receptionist at the front desk alerting her to the shipment’s arrival. A security camera mounted on the ceiling monitors every movement made with the drug, from its delivery by UPS or FedEx to the moment Morgan, joined by a member of the hospital’s security team, picks it up.

The drug, so heavily guarded it has a code name at the hospital, then travels along a route carefully mapped out by Cook Children’s head of security, a route he selected because of the number of security cameras—at least seven—that Morgan and the security guard pass as they transport the package. Along the way, there are multiple checkpoints where Morgan has to swipe her badge to enter certain hallways or elevators. Once Morgan and her security detail arrive at the drug’s final destination—a pharmacy in Cook Children’s specialty clinic—they open the Omnicell SecureVault, where the hospital stores narcotics like morphine. It takes two people to open the vault, which is safeguarded by both a pass code and a fingerprint reader. An additional security officer watches the entire process to ensure that every bottle of the drug in the package ends up in the vault.

The trip from the receptionist’s desk to the pharmacy isn’t far—maybe a two-minute walk—but the methodical delivery of the shipment to its final destination takes fifteen to thirty minutes. To an ordinary person, these extraordinary precautions would signal that the hospital is dealing with a highly addictive or dangerous substance. And when some people learn that this particular substance—cannabidiol, known as CBD oil—is a compound derived from marijuana and is classified by the FDA and DEA as a Schedule I drug like LSD or ecstasy (that it has “no currently accepted medical use”), the measures that the hospital is required to take sound more reasonable, if slightly hypervigilant.

CBD is technically medical marijuana, but this particular type is so low in THC, the psychoactive chemical in marijuana that gets people high, that a person could ingest a gallon of the stuff and not feel even a little bit mellowed out. Still, the use of medical marijuana to ease various health problems remains so controversial that despite being legal in 23 states and the District of Columbia, the federal government had banned the drug—until recently. In late 2014 Congress quietly tucked a provision into a federal spending bill that prohibits drug agents from raiding licensed medical marijuana dispensaries.

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