What is BUMP?
BUMP is a study being conducted by the San Francisco Department of Public Health to test the feasibility of providing medications to gay and bisexual men who use methamphetamine.
Why are medications being given to meth users?
We ultimately want to learn whether medications help gay and bisexual men reduce or stop their use of meth, and if this also helps reduce high-risk sexual behavior, such as anal sex without a condom. If we find that conducting this trial is feasible and acceptable, we will move on to a larger study to determine if treatment with medication results in reducing meth use and associated high-risk behavior.
Why might medications work to reduce meth use?
Small scale human and animal studies suggest that the medications we are testing may help reduce meth use. The medications being tested work on the same receptors in the brain that meth does. All medications being tested are already approved by the FDA to treat different health problems. Specifics of the medications will be explained to you during the enrollment process. However, it is important to understand that we do not know if these medications will work for you, and because some participants receive a placebo, there is a good chance that you will not receive the medication.
What will happen if I want to enroll?
First, you need to call us at 415-554-9013 to see if you might qualify. If you do, we will set up a screening visit to see if you meet our study enrollment criteria. Determining study eligibility involves assessing certain behaviors and having urine and blood tests to determine if any medical issues would keep you from being in the study. You will fill out a questionnaire on a computer and meet with a clinician who will answer any questions you have. Once you are in the study, you will be randomly selected to take a pill–actual medication or placebo–for 12 weeks. You will come in every week to provide a urine sample, which will be tested for presence of meth. You will be paid for every visit, WHETHER OR NOT YOUR URINE TESTS POSITIVE FOR METH. At each visit, you will be provided substance abuse counseling and referrals to services.
What if I decide to drop out of the study after enrolling?
As a study participant, you are free to end your participation at any time. Study staff will work with you to accommodate any difficulties you have in making study visits.
Can I enroll if I am HIV-negative? HIV-positive?
BUMP is open to men regardless of HIV status; however, you must still meet eligibility requirements.
How will I know if I received the drug?
Neither you nor the study clinician will know if you are receiving the actual medication or placebo. The pills and bottles look the same. You will be monitored for any reactions you may have to the pills and will need to alert the study clinician about any side effects you may have. After the entire study has been completed, you can find out if you received the actual medication or placebo.