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Short Term Effects of Cannabinoids in HIV Infection

August 13, 2000. Read a more complete account of the results of this study at

July 14, 2000. MAPS' most important initiative so far in the field of medical marijuana has been its work on behalf of Dr. Donald Abrams' research into the use of marijuana in HIV+ patients. Partial results of his study have just been released and are discussed in a front-page article from the San Francisco Chronicle.

May 2000. The final patient in this historic study has been treated, and analysis of the data are underway. Read the study protocol.

The History of this Study

In 1992, MAPS and Dr. Donald Abrams of UC-San Francisco began a collaborative effort to secure permission to investigate the use of smoked marijuana in the treatment of the HIV Wasting Syndrome.

Dr. Abrams' initial protocol design was approved by the FDA in Summer 1994. An application for marijuana to be used in the study was then submitted to the National Institute on Drug Abuse (NIDA), which has a monopoly on the supply of marijuana for research in the United States.

NIDA rejected the study, explaining its rationale in an April 1995 letter to Dr. Abrams, nine months after his letter requesting the marijuana. Dr. Abrams responded to NIDA´s rejection nine days later. Rick Doblin followed with a substantive critique of NIDA´s arguments.
This was the first case of NIDA refusing to supply marijuana to an FDA-approved study of marijuana. In fact, in August 1994, NIDA had provided marijuana to a waterpipe/vaporizer study co-sponsored by MAPS and CA-NORML to investigate the effectiveness of smoking devices in filtering marijuana smoke. The study was a first step toward marijuana harm reduction. It was motivated by concerns that, like tobacco, marijuana smoking poses hazards to respiratory health, a particular concern in patients with compromised immune systems.

In response to a non-violent protest at NIDA´s first National Conference on Marijuana Use in June 1995, NIDA announced a new policy that required all medical marijuana protocols to be submitted to the National Institutes of Health (NIH) for peer review in the context of a grant application. With support from MAPS, Dr. Abrams submitted a revised protocol to NIH on May 1, 1996. In August 1996, NIH formally rejected Dr. Abrams' application.

Dr. Donald Abrams prepared another protocol design for submission to the National Institutes of Health in the May 1, 1997 grant cycle. This was the third attempt by MAPS and Dr. Abrams to secure permission to investigate the use of smoked marijuana in the treatment of the HIV Wasting Syndrome.

In February 1997, the NIH convened a Workshop on the Medical Utility of Marijuana. The workshop was structured as a two-day scientific symposium with a series of presentations made by NIDA-selected experts to a NIDA-selected expert review panel. MAPS attended, partly in an attempt to offer funding for the preparation of additional applications to NIH. The meeting was well attended by the media.

The general tone of the meeting was that marijuana research should be conducted. It may be finally clear to the Clinton Administration that the continued prohibition on research will remain counterproductive from a public opinion standpoint and will add fuel to state and local reforms. This is not to say that medical marijuana research will be permitted to flourish, merely that some research probably will be permitted. The expert review panel was charged with issuing a report within a month or two of the initial workshop. MAPS submitted its recommendations to this panel.

Over six months later, the report was finally made available.

On September 18, 1997, NIDA awarded Dr. Abrams a grant of $978,000 for a study of the use of smoked marijuana, oral THC and a placebo in HIV patients being administered the protease inhibitor, Indinavir. The two-year study is the first FDA-approved study of the use of smoked marijuana in a patient population in about fifteen years. MAPS invested $10,000 - plus considerable staff time over the course of more than five years - to help Dr. Abrams obtain permission for this research. In a sense, $10,000 has been leveraged into almost $1,000,000.

A total of 63 AIDS patients who have used marijuana in the past and who are presently taking protease inhibitors will participate in Dr. Abrams' study. They will each be paid $1,000 to stay in a hospital for 25 days and either smoke marijuana, take a synthetic version of marijuana's primary active ingredient (THC) in pill form, or take a placebo. The three groups of 21 subjects will be compared in terms of HIV levels, hormone levels, and other immune-system measures. The effects of marijuana and THC on the protease inhibitor metabolism will also be examined.

Some preliminary data on caloric intake will also be recorded, but it will not be detailed enough to answer definitively any questions about marijuana's medical efficacy for AIDS patients.
Because of limited hospital space, only three patients at a time will be studied. Therefore, the study will take about a year-and-a-half to complete.

The Results of this Study

The study has found that patients with HIV infection taking protease inhibitors do not experience short-term adverse virologic effects from using cannabinoids.

Of the 62 subjects who completed the study, the 36 with undetectable HIV RNA levels remained at these levels. All 26 subjects with detectable HIV RNA levels experienced declines in HIV RNA levels. Of those, the subjects who smoked marijuana or took oral dronabinol experienced slightly greater decreases in HIV RNA levels than did subjects who took the placebos.

According to Dr. Donald Abrams, "The slightly better decline experienced by those using marijuana or dronabinol is intriguing, but not statistically significant. The good news is that there is no statistical difference between the three groups."

One difference noted by Abrams between the three arms was in caloric intake and weight gain. "All three groups gained weight. Part of that was due to regularly scheduled meals and snacks being readily available. However, the placebo arm averaged a gain of 1.30 kilograms while the subjects who took oral dronabinol gained an average of 3.18 kilograms. Those who smoked marijuana gained an average of 3.51 kilograms. Caloric intake reflected the same order.

Dr. Abrams added, "Studies of the impact of marijuana and dronabinol on protease inhibitor levels and immune system function are still ongoing."

Read more about the results from the University of California, San Francisco website

Read about the other effort to conduct medical marijuana research

1996: NIH Grant Application Process for This Study

1995: FDA-approved research and the effort to begin it

FDA Requirements for Medical Marijuana Research

  • A comprehensive clinical plan developed by MAPS in consultation with the FDA for the investigation of marijuana's medical use in the treatment of the HIV-related wasting syndrome.

    This Clinical Plan was submitted with Dr. Donald Abrams' research protocol (IND#43,542) comparing the effectiveness of smoked marijuana and the oral THC capsule in promoting weight gain in patients suffering from the AIDS wasting syndrome.It is designed to also be adapted for indications other than the wasting syndrome. Originally printed in the Summer 1994 MAPS Newsletter.

  • Minimum Informational Requirements for Establishing an FDA Drug Master File for Cannabis - Questions To Be Answered by Potential Manufacturers.

Read more about MAPS' support of medical marijuana research