CHICAGO - A migraine pill seems to help alcoholics taper off their drinking without detox treatment, offering a potential option for an addiction that is difficult to treat, researchers say.
The drug, Topamax, works in a different way than three medications already approved for treating alcoholism.
Specialists said the drug is likely to appeal to heavy drinkers who would rather seek help from their own doctors, rather than enter a rehabilitation clinic. The drug costs at least $350 a month, plus the price of doctor's visits.
But side effects are a problem, and it is unclear whether the findings make a dent in an addiction that affects millions of Americans. Addiction specialists not involved in the study said the findings are promising, although side effects such as trouble concentrating, tingling, and itching caused about one in five people to drop out of the study. Drowsiness and dizziness are also problems.
"The size of the treatment effect is larger than in most of the other medications we've seen," said Dr. Mark Willenbring of the National Institute on Alcohol Abuse and Alcoholism. "And all the drinking variables changed in the right direction."
The study, published in today's Journal of the American Medical Association, was funded by the maker of the drug, Johnson & Johnson Inc.'s Ortho-McNeil Neurologics. The researchers also reported financial ties to the company. Ortho-McNeil reviewed the manuscript, but did not change the results or interpretation, the researchers reported.
The study followed 371 heavy drinkers for 14 weeks. About half were randomly assigned to take Topamax, also called topiramate, in gradually increasing doses. The others took dummy pills.
All volunteers were encouraged, but not required, to stop drinking.
At the start of the study, they drank, on average, 11 drinks daily. That's about two six-packs of beer each day, or two bottles of wine, or a pint of hard liquor.
By the end of the study, 27 of the 183 people, or 15 percent, who took Topamax had quit drinking entirely for seven weeks or more. That compared with six out of 188, or 3 percent, in the placebo group.
Others cut back. The Topamax group was down to six drinks a day, on average, assuming everyone who dropped out of the study relapsed into heavy drinking. That compared with seven drinks a day for the placebo group.
"You can come in drinking a bottle of scotch a day and get treatment without detox," said Dr. Bankole Johnson of the University of Virginia, who led the study, which was conducted at 17 US sites from 2004-2006.
The study didn't follow the drinkers long term, so it's unclear how many relapsed after they stopped taking the pill.
But there were lasting effects for Tom Wolfe, 44, a carpenter from Earlysville, Va., who said he has been sober for two years thanks to Topamax.
"It's been a miracle to me," Wolfe said. "It got the monkey off my back."
The drug works by inhibiting dopamine, the brain's "feel-good" neurotransmitters involved in all addictions, said Stephen Dewey, a neuroscientist at the Brookhaven National Laboratory who was not involved in the study but does similar research.
Yesterday, Dr. Sidney Wolfe, director of the health research group Public Citizen, sent a protest letter to the US Food and Drug Administration questioning the promotion of Topamax for alcoholics by researchers funded by Ortho-McNeil.
"This is a very bad message to send out," Wolfe said.
Ortho-McNeil has no plans to seek federal approval for the drug as an alcoholism treatment, said Tricia Geoghegan, company spokeswoman.