HiNT is a clinical trial examining the effectiveness of the medication, oral naltrexone, taken on an as-needed basis, to help men who have sex with men and use methamphetamine to reduce and better control their meth use.
Naltrexone is a medication that has been used to help people stop using substances like alcohol and opioids (e.g., heroin, fentanyl, oxycontin). It has not been FDA approved to treat methamphetamine use, but prior research has shown it may be promising in reducing meth use as well. It works by blocking receptors in your brain that respond to these substances. Naltrexone has helped some users to reduce their cravings and use of these substances.
You may be familiar with daily naltrexone that’s taken as a pill or monthly naltrexone that’s given in a shot. Participants in the HiNT study will only take their study medication in pill form at times when they expect to do methamphetamine or crave meth. You decide when to take your study medication. As a clinical trial, participants may receive placebo (an inactive substance that looks exactly like the active treatment). For the HiNT study, 2/3 of the participants will receive a 3 month supply of naltrexone and 1/3 of participants will receive placebo. Neither you nor the study staff will know who receives which treatment until the study is completed.
Participants will receive daily text messages asking about their mood, meth use and use of study medication. The scientific term for these text messages is Ecological Momentary Assessments. These texts will help participants decide when to take their study medication.
This study is also looking at risks associated with meth use like acquiring HIV or missing doses of HIV antiviral treatment or PrEP (HIV prevention medication). This study is open to participants who are HIV negative, HIV positive, and on PrEP.
Neither you nor the study staff will know if you are receiving naltrexone or placebo. Both medications will look identical. Once the study is complete, our research staff will tell you which study group you were enrolled in.
Your participation will last up to 16 weeks (4 months). Screening for the study can take up to four weeks. Once enrolled, your participation will last 3 months. Study visits last between 30 minutes and 2 hours. You’ll be asked to come to our office at Market and Van Ness once every month for a study check-in and other assessments.
Your time and contribution are of tremendous value to public health research. If you are eligible, you can earn up to $421 for completing all study activities and procedures.
To see if you are eligible to participate, call us up at 628.217.6319. We will do a short phone interview with you to see if you would be eligible to come into our office. If so, you’ll be invited to come to our office at Market and Van Ness in San Francisco for a screening visit, where we’ll go through some questions and medical assessments to make sure it’s safe and appropriate for you to participate in the study. All of the study procedures, risks and benefits will be explained to you during the consent process.