Clinical trials are set to begin in Vancouver on a study to test the effectiveness of the prescription pain reliever Dilaudid as a treatment for chronic heroin addiction.
The Study to Assess Longer-term Opioid Medication Effectiveness (SALOME) has just cleared a major regulatory hurdle by receiving permission from the federal government to import pharmaceutical heroin, according to Eugenia Oviedo-Joekes, a researcher for Providence Health Care and a professor at the University of British Columbia.
"So now we are importing the drug and starting recruitment at the end of this year," said Oviedo-Joekes.
The study will treat 322 heroin addicts who do not respond to conventional methadone or abstinence-based programs with either injectable heroin or injectable Dilaudid, an opiate pain reliever also known as hydromorphone. In the second phase of the study, half of the subjects from each group will transition to the oral form of the same medication to determine if they maintain the same level of effectiveness.
Researchers stumbled on Dilaudid as a candidate for the treatment of heroin addiction after the medication was administered to a small group of subjects in a previous study that compared the effectiveness of medically prescribed heroin with methadone therapy in hard-to-treat addicts.
The earlier study — dubbed NAOMI, the North American Opiate Medication Initiative — found that after 12 months 88 per cent of the subjects receiving heroin were still in treatment, compared with 54 per cent of the subjects who received methadone. Researchers were surprised to find that the group administered Dilaudid were just as likely to remain in treatment as the heroin group, though the size of the Dilaudid group was too small to draw robust scientific conclusions.
Should Dilaudid prove to be as effective as prescribed heroin, the researchers hope the finding would open the door to new treatment programs for hard core addicts without the regulatory challenges and political baggage of heroin-based treatment.
The federal government refused a request by NAOMI researchers to continue to administer heroin to the addicts who had benefited from the therapy, Oviedo-Joekes said.
Provincial health officer Perry Kendall called that decision "disappointing and short-sighted."
"In Germany, Holland and Spain and in the NAOMI trial here in B.C., [hard-to-treat addicts] were helped considerably by a stint on heroin and psycho-social counselling," Kendall said. "Many people in these studies are [over time] able to get off drugs entirely."
Kendall said the cost benefits of heroin maintenance are well established, as addicts are less likely to commit crimes to buy street drugs, less likely to deal street drugs and are less likely to need hospital care for illness or accidental overdose.
"If this [Dilaudid] study proves successful, it will gives us a second line of treatment for people who aren't helped by the current best practice, which is methadone," Kendall said.
Subjects for the study will be recruited through UBC's Downtown Eastside research office and through referrals from social service agencies and groups such as VANDU, the Vancouver Area Network of Drug Users.
"We will literally walk the streets to find addicts who are using in the street," said Oviedo-Joekes. "But it won't be hard to fill the spaces, people know about this and they are calling us [to get in]."
Due to space restrictions at the clinic, only 100 subjects can be in the study at a time. In the first phase of the study, subjects may report to the clinic for an injection up to three times a day
Vancouver Sun 12th Oct 2011
Vancouver clinical trials to test effectiveness of Dilaudid as Heroin replacement.