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Additional benefit seen in study of anti-smoking drug

May 10, 2012
by Gary A. Enos, Editor
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Study subjects also drank less while using varenicline

A newly published study examining the effects of the smoking-cessation medication varenicline (Chantix) found that in a group of smokers who also drank heavily, both alcohol consumption and tobacco use decreased significantly. The study’s lead author says the findings could point to a promising new alcohol use treatment, provided that patients are screened carefully for issues that could compromise varenicline’s effectiveness.

The research, published May 1 in the journal Psychopharmacology, involved individuals who were seeking help for their smoking but not their drinking; the treatment was delivered in an outpatient clinic setting. Jennifer Mitchell, PhD, adjunct assistant professor of neurology at the University of California, San Francisco, says the study combined both subjective and objective measures of alcohol consumption, in that subjects reported drinking levels in an online diary during the 12-week study period but also submitted to urine tests for alcohol’s primary metabolite.

The researchers found in the placebo-controlled study that individuals taking Chantix were able to reduce their number of weekly drinks by 36% vis-à-vis individuals receiving placebo. The treatment did not reduce these individuals’ drinking sessions, but did reduce the number of drinks they consumed each time.

It was discovered in this study that the effects of varenicline on drinking were separate from those on smoking. “We found a primary effect on drinking, which we didn’t expect,” says Mitchell.

Mitchell describes an important consideration in how the study, which was conducted at the university’s Ernest Gallo Clinic and Research Center, was structured: “We were a little bit careful to make sure that our sample was screened for comorbidities.” In 2009, the Food and Drug Administration (FDA) required the addition of a black box warning on Chantix’s labeling amid reports of some patient effects that included depression and suicidal ideation.

In weekly patient visits for this study, individuals were assessed for signs of hostility, sleeplessness and other issues that could signal an adverse event, Mitchell says. She adds that her research team detected no problems in heart function among subjects; Chantix also has been the subject of recent scrutiny over possible cardiac effects, though Mitchell says research conclusions that pointed to this have been determined to be unfounded.

Adverse events in this latest study also related to comorbid use of stimulants such as cocaine, suggesting that patients with a history of stimulant abuse likely aren’t a good candidate for Chantix as a first-line treatment.

“If I were talking to someone in the [treatment] field, I would say that varenicline could be a useful drug in individuals who are well screened for comorbidities,” Mitchell says.



I'm not sure why the authors of this study found it a surprise. Those who know that addiction is a biological illness have been using medications aimed at one drug on the illness as a whole for over a decade. The real problem is that until last year, when ASAM published its comprehensive definition of addiction, no authoritative body looked at the illness as a single illness. Because DSM breaks it into separate diagnoses based on drug used, and the FDA requires a DSM diagnoses for an indication, there is no possibility for a medication manufacturer to create a medication for a specific biological subtype of addiction. There are smokers, opioid addicts, alcoholics, compulsive overeaters, etc who would benefit from Chantix, and there are those in each of those categories that would not. Until we get down to the biological substrates of the illness we will be surprised by these non-surprising findings.
Howard Wetsman MD FASAM

A few years ago I was working with an alcoholic that had real difficulties with remaining sober. His doctor had given him Chantix for his smoking. The great thing was he cut down smoking and he was able to stop drinking. This lasted for weeks so I email the drug company and told them about my experence.
The big problem for my client was the depression. As long as we could keep that under control he progressed well in treatment.

Glad someone was listening but you could have replied.

Jeff Rhoderick, CRADC, MHP