While the marijuana plant and its associated cannabinoids are federally illegal, the FDA seemingly has no issue with synthesized cannabinoids. Marinol, also known as dronabinol, is a synthetic form of THC.
Unlike cannabis, Marinol is legal and FDA-approved. It is primarily used to treat nausea and vomiting associated with chemotherapy and weight loss associated with HIV/AIDS.
While Marinol is no longer the behemoth it once was, it is still worth looking into the drug since tens of thousands of people still use it. This guide looks at Marinol, its uses, its side effects, and how it compares to marijuana.
What Is Marinol?
Marinol is the brand name of a form of synthetic THC called dronabinol. While it shares the same chemical formula as the THC in marijuana, the elements are arranged differently within the molecule. It consists of pure THC, which is dissolved in sesame oil and comes in pill form.
It is a controversial drug as opponents say it isn’t as effective as whole-plant marijuana. There are also a host of potential adverse effects. Furthermore, patients often find themselves having to choose between Marinol, which is covered by health insurance, and marijuana, which isn’t.
It is a drug that’s been available for decades, so let’s find out more about how Marinol came into being.
A Brief History of Marinol
Yechiel Gaoni and Raphael Mechoulam isolated delta 9-tetrahydrocannabinol from the marijuana plant in 1964.
In 1970, the Controlled Substances Act classified the plant as a Schedule I drug with no recognized medical value and a high potential for abuse. The Act was a hammer blow to any hopes of researching marijuana and its cannabinoids in the United States.
However, in 1980, the National Cancer Institute (NCI) started experimenting with a new drug called Marinol (dronabinol). The NCI tested it on cancer patients in San Francisco. What happened next arguably changed the course of medical marijuana’s history.
The creation of Marinol arguably changed the course of medical marijuana’s history.
While NCI studies found that some patients responded well to Marinol, six states conducted their own studies on marijuana. They discovered that patients found the THC in natural marijuana safer and more effective than the synthetic version. Nonetheless, the government decided to proceed with Marinol.
In 1981, the United States Government sold the Marinol patent to Unimed, who applied to the FDA for permission to market the new drug as an anti-nausea treatment. The FDA initially denied the request in November 1984 because the clinical trial results were not promising. However, Unimed quickly provided further data, prompting the FDA to approve Marinol in June 1985.
In December 1992, the FDA approved Marinol for weight loss treatment in patients with AIDS. In July 1999, Unimed successfully petitioned the DEA to move Marinol’s classification from Schedule II to Schedule III to ensure greater availability. It was a significant move. Unimed estimated that the rescheduling of the drug would see a sales increase of up to 20%.
The reason for the boost is obvious. The scheduling of a drug impacts its level of market penetration. Even today, physicians remain more apprehensive about prescribing a Schedule II drug than they do a Schedule III. There is also the small matter of Schedule II prohibition of refills, quantity restrictions, and triplicate prescriptions.
Now that we’re acquainted with Marinol’s history, what is it used for?
Marinol Uses & Dosage
Most patients use it to treat HIV symptoms or deal with the vomiting and nausea associated with cancer chemotherapy, and perhaps 10% use it for varying reasons. The final group may consist primarily of Alzheimer’s patients, even though it isn’t promoted for this form of treatment. It is usually used as a last resort when other drugs have failed.
There are also several ‘non-approved’ uses for Marinol, including as a treatment for ALS, dementia, fibromyalgia, multiple sclerosis, chronic pain, and sleep apnea.
The dosage depends on the condition. Here are the recommendations as per the FDA:
- 5 mg orally twice a day for an adult with AIDS.
- A starting dosage of 5mg every 1-3 hours before the administration of chemotherapy. After chemotherapy, use 5mg every 2-4 hours, with 4-6 doses per day. Use the first dose on an empty stomach at least 30 minutes before eating.
Marinol is available in 2.5mg, 5mg, and 10mg pills. The drug cost can vary significantly. If patients use it without health insurance, a bottle with 60 x 2.5mg pills can cost up to $800 in some instances. However, there are plenty of ways to get a better price, including using a generic version. On drugs.com, for example, patients can get 60 x 2.5mg capsules for under $100 with a discount card.
In 2016, the FDA approved Syndros, an oral solution form of dronabinol. It is used to treat the same conditions as Marinol and was manufactured by the same company, Insys Therapeutics. It had hoped to breathe new life into its drug, but its market share has not grown to the level the firm had hoped.
Next, let’s check out the advantages and disadvantages of using Marinol.
- It is legal in every state and is widely available in most pharmacies.
- It is a pure isomer of THC. Those who believe marijuana contains harmful chemicals don’t have to worry about consuming them.
- While it is a synthesized version of THC, it won’t lead to an intoxicating high.
- It has a long half-life, which means it stays at a therapeutic level in the blood for twice as long as cannabis.
- As it isn’t smoked or otherwise inhaled, it is less likely to cause lung or throat irritation.
- A variety of health insurance plans cover it.
- As it is manufactured under controlled conditions, it is less likely to be tainted.
- It has a low absorption rate, which means 10mg of THC from Marinol is not as effective as 10mg of THC from marijuana in a therapeutic sense.
- It can be far more expensive than cannabis if one’s insurance doesn’t cover it.
- The studies outlining its efficacy are contradicted by other research, which suggests it isn’t that effective.
- It has a lengthy list of side effects. While it isn’t supposed to provide an intoxicating high, some patients report feeling one all the same. We explore these issues in further detail below.
It is important to go to a doctor immediately if you faint, experience a rapid increase in heart rate, or a significant change in mental state after using Marinol.
Marinol Side Effects
Before opting for Marinol, please note that it has an array of side effects, including:
- Stomach pain
- Abnormal thoughts
Marinol could also cause an allergic reaction, leading to symptoms such as:
- Skin rash or burning
- Mouth sores
- Facial swelling
- Difficulty breathing
There is also a possibility that Marinol could lead to psychosis, particularly in those who have ever had depression or another mental illness. It could increase or decrease blood pressure and is potentially habit-forming. Patients must never give Marinol to someone it is NOT prescribed for. Also, it is extremely potent. Even 5mg is too much for some patients to deal with.
Anyone who uses this drug, shouldn’t operate any heavy machinery or engage in anything that requires their full attention. This is because it could impair reaction or thinking times. Individuals must wait until the effects wear off first.
How Long Does Marinol Stay in Your System?
The body absorbs the dronabinol in Marinol similarly to the THC found in the marijuana plant. Marinol gets broken down and excreted in the urine for 48 hours to five weeks. It is detectable in drug tests during this period.
Please note that some of the dronabinol gets stored unchanged in fat cells. After it gets released into the body, it could once again cause intoxicating effects. The half-life of THC stored in fat is 10-13 days. However, the synthetic THC is detectable in hair follicles for approximately three months.
However, the above is only a ballpark estimate. In reality, the length of time Marinol stays in your system depends on factors including:
- Physical activity
- Body mass
- Hydration level
- Health conditions
If you use Marinol and face a company drug test or a pre-employment screening, please disclose this information before the test.
Marinol was approved for use in 1985 despite a lack of data that backed up the claims of its manufacturers. The fact that it is consumed orally massively hinders the drug’s performance because much of the THC is metabolized before reaching the bloodstream.
It took a long time for hard evidence to emerge. One of the first studies that somewhat legitimized dronabinol took place in 1995, a full decade after the drug’s approval. The study by Beal et al. was published in the Journal of Pain Symptom Management. It involved just 139 patients with AIDS-related anorexia.
Each patient received 2.5mg of dronabinol twice a day or a placebo. Efficacy was only evaluable in 88 of the volunteers. The researchers found that those who used the drug enjoyed an increase in appetite of 38% above the baseline, compared to 8% of those who used the placebo.
A larger study, by Tramer et al., published in the British Medical Journal in 2001, looked at the effectiveness of cannabinoids in 1366 patients. The researchers used oral dronabinol, intramuscular levonantradol, and oral nabilone. They found that the cannabinoids were effective when treating the vomiting and nausea caused by chemotherapy.
Is There More Recent Research?
Yes, although there are relatively few studies when one considers it is an FDA-approved drug.
A review of studies on THC, conducted by Grant et al. at the University of California Center for Medicinal Cannabis in 2012, analyzed findings of studies into Marinol. The researchers found that a 25mg dose of Marinol was better at achieving pain relief in patients with multiple sclerosis than a placebo. They also found that a 25mg dose was better at reducing chronic neuropathic pain than a placebo.
However, a 2016 study by May and Glode, published in Cancer Management and Research, concluded that there was “insufficient data to support the use of dronabinol as an antiemetic in all chemotherapeutic regimens.” They did, however, concede that it has some “beneficial effects.”
A 2020 study found that those who used Marinol consumed significantly fewer opioids than the placebo group.
Finally, in 2020, researchers published the results of a pilot study featuring Marinol. They looked into its effects on 66 patients admitted to the hospital with a traumatic injury between March and October 2017. The study found that those who used Marinol consumed significantly fewer opioids than the placebo group. The researchers also wrote that the opioid-sparing effects of Marinol were potentially greater in cannabis users.
Now, let’s find out more about the great Marinol vs. marijuana debate.
Marinol Versus Marijuana
Although the usage of Marinol is on the wane in the United States (it was discontinued in Canada), it still has its proponents. Remember, while Marinol contains THC, it is nothing like the THC found naturally. Marinol does not contain the hundreds of compounds found in cannabis.
Why is this important? The cannabinoids and terpenes found in marijuana likely reduce the negative effects associated with THC, such as anxiety and dizziness. Certainly, CBD (cannabidiol) helps reduce the intoxicating high people get from THC.
In 2001, Lester Grinspoon, Professor of Psychiatry at Harvard Medical School, said he had yet to find a patient that found Marinol more useful than natural marijuana. He asserted that if marijuana were legal, few patients would choose Marinol.
In 1999, the Institute of Medicine said that Marinol isn’t effective because taking it orally slows the absorption rate and prevents patients from having control over dosing. In 2002, Andrew Weil from the University of Arizona’s School of Medicine condemned Marinol by saying it isn’t effective enough. He spoke to numerous patients, and all of them said the pill didn’t work as well as natural marijuana, and it resulted in even greater intoxication.
There is proof of the above assertions in the form of a study by Hazekamp et al., published in the Journal of Psychoactive Drugs in 2013. In it, researchers asked 953 people to complete a survey and answer whether they preferred synthetic THC or ‘the real thing.’ Fewer than 2% of respondents said they preferred synthetic THC, which suggests that Marinol’s severe decline is down to greater availability of marijuana.
In 2002, Robert L DuPont, the President of the Institute for Behavior and Health, led the rebuttals. He claimed that cannabis plants are “unstable mixtures of different chemicals” and should not be used for medical treatment.
DuPont also said no plant should ever be allowed as a medicinal treatment because they can’t be used directly to provide a specific dosage of any chemical. In contrast, Marinol provides a pre-measured dose of THC, which he believes is a much better option.
Marinol provides a pre-measured dose of THC, which could be a better option for many patients.
It was interesting to read that DuPont used the FDA’s approval of Marinol in 1985 as proof that it was a better option than natural marijuana. This is despite several state studies which clearly showed that patients not only preferred natural THC but claimed it was more effective.
In 2006, the Office of National Drug Control Policy (ONDCP) cited the 1970 Drug Abuse Prevention and Control Act, which classified marijuana as a Schedule I drug with no recognized medical value. The ONDCP described Marinol as a “safe and legal version of medical marijuana.” It claimed that smoking marijuana was likely to harm your health.
However, unbiased analysis suggests that Marinol is, in fact, inferior to medical marijuana.
8 Reasons Marinol Loses to Marijuana
- It is very expensive, and if a patient’s insurance doesn’t cover it, they may not be able to purchase it.
- Marinol is believed to cause many more side effects than cannabis.
- It can take up to 90 minutes to feel the effects. In contrast, marijuana can provide relief in a matter of minutes.
- The dosages of Marinol are rigid. When smoking a joint or vaping cannabis oil, patients can adjust the dose as needed.
- If Marinol is stored outside of a temperature range of 46 to 59 degrees Fahrenheit, it can break down.
- Hypersensitive reactions include rashes, hives, a burning sensation, throat tightness, and lip swelling.
- Overall, the level of relief patients get is severely limited when compared to medical marijuana.
- The bioavailability of Marinol is extremely poor. No more than 20% of the synthesized THC reaches the bloodstream.
Final Thoughts on Marinol
Marinol’s success was primarily based on the limited availability of medical marijuana. When it was initially released, it had a decade-long run before a single American state, California, legalized MMJ in 1996. While its market share remained high for a long time, it has severely dwindled in recent times. With a significant majority of states now allowing medical marijuana, many patients don’t want to use Marinol.
An increasing number of studies conclusively prove that medical marijuana is a vastly superior treatment to pharmaceutical drugs for dozens of conditions ranging from PTSD to chronic pain. Marinol’s impact is relatively limited, and it carries several side effects.
Also, it is extremely difficult for patients to self-adjust their dosage. This is because Marinol comes in pill form and takes much longer to become effective than smoked marijuana. Many of the side effects associated with Marinol don’t occur in natural marijuana because its additional compounds counteract many of the negative effects of THC. Marinol will continue to sell well, but it is clear that patients prefer natural THC, just like they did in 1980.