Anti-smok­ing shot on the way

Mea­sure helps some quit, study finds; may of­fer new op­tion

The Covington News - - HEALTH & WELLNESS - By Mike Stobbe

OR­LANDO, Fla. — A shot that robs smok­ers of the nico­tine buzz from cig­a­rettes showed prom­ise in mid­stage test­ing and may some­day of­fer a rad­i­cally new way to kick a dan­ger­ous habit.

In a study, more than twice as many peo­ple given five of the shots stopped smok­ing than those given fewer or phony shots — about 15 per­cent ver­sus 6 per­cent af­ter one year.

That is com­pa­ra­ble to some other smok­ing ces­sa­tion aids cur­rently sold and could be an im­por­tant new tool for peo­ple who have failed to quit on other meth­ods, doc­tors said.

The re­sults, pre­sented Wed­nes­day at an Amer­i­can Heart As­so­ci­a­tion con­fer­ence, do not prove the new approach works but en­cour­aged some ex­perts.

“ It clearly shows prom­ise” and mer­its a de­fin­i­tive study, said Dr. Frank Vocci, di­rec­tor of med­i­ca­tions de­vel­op­ment at the Na­tional In­sti­tute on Drug Abuse, which has given $ 8 mil­lion for the re­search so far.

“ There’s merit in it,” but it won’t be avail­able to­mor­row, said the lead re­searcher, Dr. Stephen Ren­nard of the Univer­sity of Ne­braska.

The study tested NicVAX, a vac­cine de­signed to “ im­mu­nize” smok­ers against the rush fu­el­ing their ad­dic­tion. It’s made by Nabi Bio­phar­ma­ceu­ti­cals of Boca Ra­ton, Fla.

The treat­ment keeps nico­tine from reach­ing the brain, tak­ing the fun out of smok­ing and hope­fully mak­ing it eas­ier to give up. Some nico­tine still gets in, pos­si­bly eas­ing with­drawal, the main rea­son quit­ters re­lapse.

This approach — at­tack­ing de­pen­dency in the brain — is dif­fer­ent than just re­plac­ing nico­tine, as the gum, lozenges, patches and nasal sprays now sold do.

The study in­volved 301 long­time smok­ers in Min­neapo­lis, Omaha, San Fran­cisco, Los An­ge­les, Bos­ton, New York City and Madi­son, Wis.

Par­tic­i­pants were given four or five shots within six months, at one of two doses, or dummy shots. Nei­ther they nor their doc­tors knew who got what.

Ini­tial shots “ prime” the im­mune sys­tem. Later doses make it pro­duce an­ti­bod­ies, which latch onto nico­tine in the blood­stream and keep it from cross­ing the blood­brain bar­rier and main­tain­ing the ad­dic­tion.

One year into the study — six months af­ter vol­un­teers re­ceived the last shot — 14 per­cent on the lower dose and 16 per­cent on the higher dose of five shots had quit. Only 6 per­cent of those given four shots, or the fake vac­cine, were off cig­a­rettes.

“ Th­ese quit rates are com­pa­ra­ble to what’s seen in other stud­ies for things that are con­sid­ered to work,” Ren­nard said.

More peo­ple in the vac­cine groups dropped out of the study — 74 out of 201 ver­sus 33 of the 100 in the placebo group.

Two vac­cine re­cip­i­ents had mi­nor side ef­fects, Ren­nard said.

“ Th­ese are im­pres­sive pre­lim­i­nary data,” said Dr. Sid­ney C. Smith Jr., a car­di­ol­o­gist at the Univer­sity of North Carolina at Chapel Hill and past heart as­so­ci­a­tion pres­i­dent.

Get­ting peo­ple to quit smok­ing “ may well be at the top of the list” for im­prov­ing pub­lic health, said Smith. World­wide, an es­ti­mated 1.3 bil­lion peo­ple smoke, ac­cord­ing to the heart as­so­ci­a­tion and it’s a lead­ing cause of can­cer and heart dis­ease.

Oth­ers were im­pressed.

“ I’m a lit­tle un­der­whelmed,” said Dr. Ti­mothy Gard­ner, a heart as­so­ci­a­tion spokesman and car­di­ol­o­gist at Chris­tiana Care Health Sys­tem in Ne­wark, Del. “ I would think we could ex­pect bet­ter” with such a novel approach, and it is hard to un­der­stand why five shots worked and four did not, he said.

The Food and Drug Ad­min­is­tra­tion has granted the vac­cine fast- track sta­tus, mean­ing it will get prompt re­view.

Two sim­i­lar vac­cines are in mid­stage test­ing: TA- Nic, by Ber­muda- based Celtic Phar­ma­ceu­ti­cals, and NicQb, a prod­uct whose mar­ket­ing rights Cy­tos Biotech­nol­ogy AG re­cently sold to Switzer­z­land- based No­var­tis AG.

A sim­i­lar “ brain approach” to smok­ing ces­sa­tion is taken by Pfizer Inc.’s Chan­tix, a drug that went on sale in Au­gust 2006. In a study of it, re­searchers re­ported oneyear smok­ing ab­sti­nence rates of 22 per­cent ver­sus 16 per­cent of those given the smok­ing ces­sa­tion drug Zy­ban.

With the vac­cine, peo­ple who have not quit may re­quire pe­ri­odic boost­ers to keep try­ing, Vocci said.

Of the roughly 46 mil­lion smok­ers in the United States, 40 per­cent each year make a se­ri­ous at­tempt to quit, but fewer than 5 per­cent suc­ceed long- term.

Mario Musachia had tried

not

as many times be­fore join­ing the NicVAX study at the Univer­sity of Wis­con­sinMadi­son. He still strug­gles with the ad­dic­tion, though it is not yet known whether he re­ceived vac­cine or dummy shots, said Douglas Jorenby, the psy­chol­o­gist who heads that study site.

“ We def­i­nitely have quit­ters and peo­ple who are ab­so­lutely con­vinced they got the ac­tive vac­cine,” Jorenby said.

One wo­man did not want to be told whether she had re­ceived the real thing or fake vac­cine.

“ She was com­pletely fo­cused on the fact that she was quit and she didn’t want any­thing to un­der­mine that,” Jorenby said.

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