Medical Marijuana Study in San Francisco: Pays $1000, 25 Days in Hospital
An important medical marijuana study now recruiting will pay $1000 to volunteers who meet the entry criteria and successfully complete the trial. The main drawback is that you must spend 25 days in a research ward at San Francisco General Hospital--without leaving during that time, and without receiving visitors (due to Federal rules for studying marijuana). You can make unlimited phone calls, have access to a TV and VCR, use the Web, and bring books and a laptop computer.Volunteers will be randomly assigned to either smoke marijuana cigarettes (4% THC) three times a day, take dronabinol (Marinol) capsules (2.5 mg) three times a day, or take placebo capsules. There is a one-third chance of being assigned to each group.
"Our main goal is to find out what is safe for HIV/AIDS patients," said principal investigator Donald Abrams, M.D., professor of medicine at the University of California San Francisco (UCSF), who has fought for years to get Federal permission to study marijuana. "We know many patients use marijuana to relieve nausea and loss of appetite brought on by the disease and its treatments, but we don't know how THC--the active ingredient in marijuana--interacts with HIV drug therapies. For example, protease inhibitors like indinavir and nelfinavir are metabolized by the liver, as is THC. We want to see if THC alters the metabolism of protease inhibitors and therefore changes the concentration of the drug in the blood, either creating a level that is too high, producing toxicities, or is too low, rendering the protease inhibitor ineffective." The study will also look for any effect of marijuana on viral load, the immune system, testosterone levels, appetite, energy intake, resting energy expenditure, body composition, and body weight.
This study is funded by a grant from the U.S. National Institutes of Health. Besides Dr. Abrams, other researchers are: Morris Schambelan, M.D., UCSF professor of medicine; Kathleen Mulligan, Ph.D., UCSF assistant professor of medicine; Neal Benowitz, M.D., UCSF professor of medicine and pharmacology; Francesca Aweeka, Pharm.D., UCSF clinical pharmacist; Joseph M. McCune, M.D., Ph.D., UCSF associate professor of medicine; Joan Hilton, Sc.D., M.P.H., UCSF assistant professor of biostatistics/epidemiology; Tarek Elbeik, Ph.D., UCSF assistant researcher/medicine; Roz Leiser, R.N., Community Consortium study coordinator; and Thomas Mitchell, M.P.H., Community Consortium program director.
To be eligible, you must:
be HIV-positive and taking either indinavir or nelfinavir and no additional protease inhibitors (other antiretrovirals are OK);
Have a stable viral load and have been on stable antiviral medicines for at least eight weeks;
Have used marijuana previously (at least six times in your life);
Be willing to not use marijuana for up to three months;
Not have active opportunistic infections or malignancies requiring acute treatment;
Not have had unintentional weight loss of greater than 10% in the last six months;
Not be a tobacco smoker (currently or within the last 30 days), be dependent on any recreational drugs, be on methadone maintenance;
Not be pregnant;
Meet certain other medical conditions.
For more information about volunteering for this trial, call the Community Consortium THC Study at 415-502-5705.
