Peer Educator: I'm T and I'm a Peer Educator for the Speed Project at the San Francisco AIDS Foundation. I'd like to ask you a couple of questions. What is the BUMP study about?

Rob Guzman: The BUMP study is a biomedical intervention trial of the drug called Bupropion, which is also known as Wellbutrin and also known as Zyban. The study is for men who have sex with men that are meth dependent, which means they have to meet a very specific criteria of how much they use meth and the impact it has on their life to be considered dependent. So what we're doing in this study is randomizing people to receive the study drug or placebo and. This is a small study so we will not be able to determine efficacy in other words we won't know by the end of it whether or not the people that got the drug versus the placebo reduced their meth use, reduced their sexual risk behavior or anything like that but it is a sort of preliminary study that will help us understand if this is something we can try to do in a larger trial and if there are no major problems with this phase of the study then we can try to apply to get funding for a larger study that would tell us whether or not this drug helps people get off meth or reduce their meth use and consequently their high risk sexual behavior that can be associated with meth use.

Peer Educator: Ok and how long is the study for?

Rob Guzman: It will probably go for close to another year but for people who take part in the study they'll have a couple of initial visits but once they enroll it's 12 weekly visits and then they are done and there is no long term follow up.

Peer Educator: Ok and what does Wellbutrin do?

Rob Guzman: They sort of don't completely understand how it works, even for depression which is what it has been approved for. It is also approved to treat nicotine addiction from smoking but there is some evidence based on anecdotal information and animal studies that it may work on the same receptor in the brain as meth does. When you are on meth it increases the amount of dopamine in your brain and that of course is what makes you feel good and euphoric and it may be that Wellbutrin works to somewhat counteract that. Basically when they have given rats Wellbutrin and they have allowed the rats to self administer meth, they self administered less meth while taking Wellbutrin. So that leads us to believe that there might be some biological reason that it might work to reduce meth use and I think it may be that since we also know that it works for smoking (we know they are totally different drugs) but there is some evidence that it may impact meth addiction or meth dependence.

Peer Educator: So in this study, this is the only medication that is being used?

Rob Guzman: Yes and in this study actually two thirds of the people will get Wellbutrin and one third will get the placebo.

Peer Educator: Why is it being given to guys who use crystal?

Rob Guzman: What a lot of guys who use meth tell us is that when they use crystal even though they may be very committed to staying safe or protecting their health or trying not to get or transmit HIV, that all that goes out the window and that sex becomes something very different and their inhibitions are lessened. We know from studies where we look at risk behavior it tends to be 2 to 3 times higher among guys who use meth. So guys who use crystal if they are negative initially, they are 2 to 3 times more likely to get infected over time compared to guys who do not use meth at all and that is true for people are infrequent users as it is true for people that are more frequent users.

Peer Educator: How would it work to reduce someone's use if they are seeking that?

Rob Guzman: Well we hope that the drug somehow has an impact on their brain that makes a person have less cravings for meth and that if they have already sort of made somewhat of a decision that they want to reduce their meth use that the presence of this chemical in their body makes them naturally reduce their meth use. Again though this is all theoretical and that is ultimately what we want to test out. The important point is that people who are definitely seeking treatment and want treatment right now then this really isn't the best option for them because this is something for people that want to decrease their use. If somebody feels that it is really at the critical point and they want to go into something that has been proven more effective, like an inpatient or outpatient program that's available now, that might be a better option for some people. People in this study do get counseling, they do get referrals to treatment, they get drug and sexual risk reduction counseling and they get that, I believe, at every visit.

Peer Educator: If I would want to enroll, what would be the process?

Rob Guzman: You would call our study line number at 415 554 9013 and just say that you are interested in the BUMP study because we do a number of studies here and it helps the counselors that talk to people here figure out which study to screen them on. Then we ask you a number of questions, if a person meets a certain enrollment criteria then they can get scheduled for a screening visit, there are two screening visits, and if they again meet the more strict eligibility criteria and their blood measures on various things fall within certain parameters then they can be enrolled in the study.

Peer Educator: Do I have to be clean and sober or can I be actively using?

Rob Guzman: You can't be clean and sober because you have to be considered meth dependent. As we know though, a lot of people can go back to using so this could be for someone who has relapsed and wants to try something different and potentially this could work for them. Again I cannot emphasize enough that people should not go into this study thinking that, "oh, this is definitely going to work for me," or "this is a known efficacious drug," because we cannot say that and they could end up getting a placebo anyway. If they agree to enroll they have to be able to stick with the 12 weeks and visits and taking the study's drug, whether or not they think they got the placebo and that is really critical.

Peer Educator: What would happen if while I'm in the middle of the study, I want to drop out?

Rob Guzman: People can drop out anytime, that is just a right that research participants have. Of course we do try to get people that initially feel like they really can make the commitment because once somebody is enrolled in this study, and we're only looking for 30 people, that one person counts. For example, if that one person enrolls and they never show up again they count basically as much as somebody that came all 12 times and so that hurts our ability to get any meaningful data in the study. So we really encourage people to come to their visits and if they miss one weekly visit, they should not feel bad and they can come back and make every effort to try to come to all future visits. We will not make them feel bad about missing that one visit and they will still get reimbursed for each visit.

Peer Educator: Do I have to be HIV negative or positive?

Rob Guzman: You can be positive or negative but at this point people that are on anti-retroviral medications, since this is a new drug that we are testing out we want to minimize potential side effects with other drugs and things like that. So, ultimately if you are HIV positive and you are on anti-retrovirals then it may not be a good idea for you to be involved in this study.

Peer Educator: How will I know if I did receive the drug or some placebo?

Rob Guzman: Ideally, there would be no way to know until the end of the study. Once the study is totally done then participants will have the option to find out whether they got the drug or placebo.

Peer Educator: What about side effects?

Rob Guzman: So the major side effects are headache, nausea and dry mouth and in earlier studies of the drug those things were slightly more prevalent or equally prevalent in the placebo group too. It's common for people to get headaches.

Peer Educator: If I attend a drug treatment program (abstinence or harm reduction based) am I still eligible?

Rob Guzman: That might be one of those things that people just need to call in and it will be dealt with on a case by case basis. Some of these things too...we cannot totally give away the criteria for eligibility. So basically people are not definitely excluded if they are attending a drug treatment program, it just depends on the specifics of the drug treatment program. Certainly if somebody is in an inpatient treatment facility and they cannot make it to the study visits then we cannot enroll them until they are in a space where they can come to the visits.

Peer Educator: How is the stipend being distributed?

Rob Guzman: It is cash and it's given at the end of each of the visits, although one of the visits is split into two parts so they actually get it at the end of the second part.