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Suboxone reduces withdrawal symptoms after addicts stop using heroin or other opiates. It is made up of Buprenorphine, a pain-relief medication, and Naloxone, an opiate blocker that has no effect if taken orally but causes people to feel sick if they abuse the drug by injecting it.
Recruitment of participants for the study began last month, and so far one addict has been enrolled, said Megan Ghiroli, the coordinator of the Suboxone study at Zucker Hillside. Researchers want to recruit 44 participants as part of a nationwide study involving 11 study clinics and 480 opiate addicts.
"Opiate withdrawal is just such a miserable experience," said Dr. Jeff Selzer, the director of addiction treatment services at Zucker Hillside, a psychiatric division of the North Shore-Long Island Jewish Health System. "If you're feeling lousy and in withdrawal and all you have to do is take more heroin or Percodan and you feel better again, it's really hard (to stop abusing opiates). Buprenorphine can greatly reduce withdrawal symptoms."
Opiate addicts often experience "the shakes," diarrhea, watery nose, yawning, hot and cold flashes, goose bumps, sweating, fevers, sleeplessness, depression and anxiety when they stop abusing drugs.
"Opiate" refers to a category of pain-relieving drugs, including heroin and opium. Aside from heroin, people also abuse prescription opiates such as OxyContin, Demerol, Percodan and Percocet.
"People who use heroin can have a euphoric feeling, but what people more describe is just being very indifferent, which is a real problem if you've got life problems you've got to work on," Selzer said.
Selzer said that since the mid-1990s there has been a four-fold increase in heroin use in metropolitan areas including New York City in youngsters up to 18 years old. In young adults over 18, heroin use has doubled.
"Part of the problem is that it's become less expensive in the New York City area in particular," Selzer said. "Also, the purity is greater, and the greater purity allows people to either smoke it or take it intra-nasally."
Some people mistakenly think they cannot become addicted to heroin if they smoke it or sniff it, Selzer said.
According to the study's protocol, participants will be put on Suboxone for one month, during which they will take the medication, an orange-flavored tablet that dissolves under the tongue, as prescribed by a doctor. All treatment will be free.
After one month, participants will be randomly put into one of two study groups. One group will be gradually taken off Suboxone over the course of 28 days, while the other will be pulled off the medication more quickly over even days.
"With this study they're trying to learn more about the taper schedule," Ghiroli said.
Though numerous clinical trials were done on Suboxone before it was FDA-approved last year, more study needs to be done to fine-tune the best way for doctors to administer the drug, Ghiroli explained. One question the study is trying to answer is what is the best way to wean people off of Suboxone treatment.
Ideally, participants should no longer be addicted to heroin or other opiates after they finish going through the study's treatment. Since addiction is highly psychological, mental counseling is provided throughout the study.
"What we're trying to do with the study in addition to being part of this clinical trial is draw more people into treatment," Selzer said.
Buprenorphine has been used as a pain-relief medication for more than a decade in the United States, but it was not approved to treat opiate addiction until recently, after doctors in France showed through their studies that deaths from heroin overdose declined significantly as Buprenorphine became more available.
After being proven effective for treating opiate addiction, Buprenorphine was mixed with Naloxone to prevent people from abusing the drug by injecting it. The mixture is called Suboxone.
Suboxone may be more appropriate for some opiate addicts than methadone, the only other agent approved for outpatients addicted to opiates, because it can be prescribed in a doctor's office. By contrast, methadone can only be given out in clinics and requires addicts to go to their clinic five or six times a week.
"We don't see this as something that's competitive with methadone or something that would replace it. It's just an additional option for patients," said Selzer, who noted that some people may be reluctant to go to methadone clinics because of the stigma attached to them.
Opiate addicts who wish to participate in the study can find out more by calling 718-470-8950.
Reach reporter Tien-Shun Lee by e-mail at firstname.lastname@example.org, or call 718-229-0300, Ext. 155.
©2004 Community Newspaper Group
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