The Sinclair method for tobacco using Chantix
Kenneth Anderson
Effect of varenicline on smoking cessation through smoking reduction: a randomized clinical trial.
Abstract
IMPORTANCE:
Some cigarette smokers may not be ready to quit immediately but may be willing to reduce cigarette consumption with the goal of quitting.
OBJECTIVE:
To determine the efficacy and safety of varenicline for increasing smoking abstinence rates through smoking reduction.
DESIGN, SETTING, AND PARTICIPANTS:
Randomized, double-blind, placebo-controlled, multinational clinical trial with a 24-week treatment period and 28-week follow-up conducted between July 2011 and July 2013 at 61 centers in 10 countries. The 1510 participants were cigarette smokers who were not willing or able to quit smoking within the next month but willing to reduce smoking and make a quit attempt within the next 3 months. Participants were recruited through advertising.
INTERVENTIONS:
Twenty-four weeks of varenicline titrated to 1 mg twice daily or placebo with a reduction target of 50% or more in number of cigarettes smoked by 4 weeks, 75% or more by 8 weeks, and a quit attempt by 12 weeks.
MAIN OUTCOMES AND MEASURES:
Primary efficacy end point was carbon monoxide-confirmed self-reported abstinence during weeks 15 through 24. Secondary outcomes were carbon monoxide-confirmed self-reported abstinence for weeks 21 through 24 and weeks 21 through 52.
RESULTS:
The varenicline group (n = 760) had significantly higher continuous abstinence rates during weeks 15 through 24 vs the placebo group (n = 750) (32.1% for the varenicline group vs 6.9% for the placebo group; risk difference (RD), 25.2% [95% CI, 21.4%-29.0%]; relative risk (RR), 4.6 [95% CI, 3.5-6.1]). The varenicline group had significantly higher continuous abstinence rates vs the placebo group during weeks 21 through 24 (37.8% for the varenicline group vs 12.5% for the placebo group; RD, 25.2% [95% CI, 21.1%-29.4%]; RR, 3.0 [95% CI, 2.4-3.7]) and weeks 21 through 52 (27.0% for the varenicline group vs 9.9% for the placebo group; RD, 17.1% [95% CI, 13.3%-20.9%]; RR, 2.7 [95% CI, 2.1-3.5]). Serious adverse events occurred in 3.7% of the varenicline group and 2.2% of the placebo group (P = .07).
CONCLUSIONS AND RELEVANCE:
Among cigarette smokers not willing or able to quit within the next month but willing to reduce cigarette consumption and make a quit attempt at 3 months, use of varenicline for 24 weeks compared with placebo significantly increased smoking cessation rates at the end of treatment, and also at 1 year. Varenicline offers a treatment option for smokers whose needs are not addressed by clinical guidelines recommending abrupt smoking cessation.
TRIAL REGISTRATION:
clinicaltrials.gov Identifier: NCT01370356.
Stanton Peele
“[F]or persons who have progressed to dependence on alcohol or other drugs the sojourn has been difficult. Once past a certain point there is no turning back. Continuing the journey, with any expectation of health and well-being, will require substance abuse treatment.”
Do recall, Ken, that whenever I query an audience, the overwhelming majority who say that they have quit smoking indicate that they did so without any kind of therapy. This occurred at the workshop I presented under your auspices at the New School -- so that according to the evidence before your eyes, you are a notable exception among those around you. Yet your current post, citing your personal case, denies this example of the dominance of natural recovery you have witnessed in front of your eyes.
So at least we know the answer to Maia's question: "Why is natural recovery regularly denied?"
Drug-assisted smoking treatment is the most promoted example of addiction treatment in the US in the form of nicotine replacement therapy. Trials of NRT regularly find it effective in quitting, as noted in this NY Times article: "In medical studies, the products have proved effective, making it easier for people to quit, at least in the short term." The study you cite followed up for a year. But the study described in this article on the front page of the Times "interviewed the participants three times, about once every two years." Its purpose "was to see whether nicotine replacement affected their (quitters) odds of kicking the habit over time. It did not, even if they also received counseling with the nicotine replacement."
How often do those who back a technique in their practice find it to be useless, counterproductive? For, in the study, more highly dependent smokers were significantly less likely to succeed when relying on NRT than equivalent smokers who did not. Why would this be? Here is how Ilse and I explain the phenomenon in Recover!
There is a substantial backlash reported in the Times article by the many professionals who rely on NRT, which is massively marketed by the industry with claims about the impossibility of self-quitting. This is part and parcel of the process noted by Robert Whittaker when you interviewed him about his book, Anatomy of an Epidemic, which traces the epidemic appearance of mental illness diagnoses in the US in recent decades to the complete control of over mental health care by biological psychiatry and the pharmaceutical industry. Do you believe Whittaker is mistaken?
This continuing reliance on therapies whose impact seems to be counterproductive (per Whittaker) is recapitulated in the Times article, where those objecting to the NRT study say that the reason for its failure is the smokers' failure at compliance (just like AA claims)! The article notes (per Whittaker): "The market for nicotine replacement products has taken off in recent years, rising to more than $800 million annually in 2007 from $129 million in 1991. The products were approved for over-the-counter sale in 1997, and many state Medicaid programs cover at least one of them. . . .A government-appointed panel that included nicotine replacement as part of federal guidelines for treatment also came under fire, because panel members had gotten payments from the product manufacturers."
“Our
study essentially shows that what happens in the real world is very
different” from what happens in clinical trials, said Hillel R. Alpert
of Harvard, a co-author with Dr. Connolly and Lois Biener of the
University of Massachusetts, Boston. The
researchers argue that while nicotine replacement appears to help
people quit, it is not enough to prevent relapse in the longer run.
Motivation matters a lot; so does a person’s social environment, the
amount of support from friends and family, and the rules enforced at the
workplace.
Ilse and I offer an added interpretation to the failure of the NRT study in Recover! -- one that people lost in our cultural miasma find very difficult to fathom. We say that defining yourself as having a disease that requires treatment itself undercuts the self-efficacy required to change. Or, as Bill Miller found, belief in the disease theory itself predicts relapse following treatment for alcoholism (as he describes on camera in Greg Horvath's new film, "The Business of Recovery"). Can you grasp this concept Ken? Frankly, I don't think that you and Maia get it, and in this way you strongly support the idea of powerlessness you claim to despise in AA.
This cultural belief is very, very insidious -- this process has now been noted and analyzed in the major intellectual organ in America, the NYRB. Whenever a new treatment is developed in any area of mental illness, that condition never declines -- it only increases. Whittaker argues, using big data, that our very reliance on a way of viewing and responding to mental illness digs a deeper mental health hole for us, causing us to more desperately turn to the very treatments that cause the epidemic. (Parallel to the question of evidence-based addiction treatment is a similar one on mental health treatment: “Basic research into the biology of mental disorders and treatment has stalled, . . . confounded by the labyrinth of the brain. Decades of spending on neuroscience have taught scientists mostly what they do not know, undermining some of their most elemental assumptions.”) Yet our disease culture (remember Diseasing of America, Ken?) makes it impossible for us to identify this phenomenon. And a large part of this process involves denial of natural recovery. I wish the idea of self-cure were more readily grasped, but it is not (see your and Maia's posts). Ken, as you (bless your soul) constantly refer to how my work made you see this pattern re alcoholism, saving your life, you are busy rejecting that vision.
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Maia Szalavitz
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mai...@gmail.com / 212-879-2305
Health Writer, TIME.com
co-author, with Bruce Perry, MD, PhD,
"Born for Love: Why Empathy is Essential-- And Endangered" (Morrow, 2010)
author, "Help At Any Cost: How the Troubled-Teen Industry Cons Parents and Hurts Kids" (Riverhead, 2006)
(Please note: Short emails likely due to overworked hands— "shortness" of tone definitely not intended!)
Maia Szalavitz
Stanton Peele
Recover! Stop Thinking Like an Addict, and Stanton's other books: www.amazon.com/Stanton-Peele/e/B000APH1ZW
On-line Life Process Program: www.lifeprocessprogram.comContributor, The Fix: http://www.thefix.com/tags/stanton-peele
Contributor, Rehabs.com: http://www.rehabs.com/author/stanton-peele/
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Laura Tompkins
Sent from my brain.
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Kenneth Anderson
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Kenneth Anderson
A Harm Reduction Approach to Quitting Smoking
I just wanted to tell my story about getting off nicotine and how I used elements of harm reduction and use-extinction to do so.
I started by taking Chantix (which is a partial nicotine agonist). I chose Chantix over the patch or gum because it has the best success rate–up to 50% total abstinence.
However I totally rejected the idea of doing the Chantix plan. I needed to make my own plan, When I make my own plans I succeed with them because I am personally involved with them. When others impose plans upon me I am not interested.
This is the first Harm Reduction principle applied: When people are involved in creating their own plans then they are invested in completing those plans.
My insurance would not pay for Chantix–so I had to pay out of pocket. This is another principle which is universal rather than harm reductionist: people put value on what they pay for—whether they pay with money or effort.
One part of the Chantix plan online is a calculator which tells you how much money you save by not smoking. This would definitely be backfiring in my case. I only smoke Bugler rolling tobacco–and it costs me $50 a month to smoke. The Chantix alone costs $150 a month so smoking is much cheaper than Chantix for me.
The second harm reduction element which I worked into my quit cigarettes plan is charting. I started keeping a detailed record of every single cigarette I smoked and within a week of starting the Chantix I was down to half of what I usually smoked.
The third harm reduction technique I used was to stop keeping a supply on hand. I have always bought my Bugler tobacco by the can which is enough for a week or more. Now I started buying it only by the pouch so I would only have enough available for a day or so.
The fourth harm reduction technique I used was to get nicotine gum and chewing tobacco so that I would never have to feel deprived of nicotine any time that I chose not to smoke. I have never opened either the gum or the pack of chew–but I take great psychological comfort in knowing that they are in my backpack handy to me at any time.
I had some withdrawal a few days after starting the Chantix but it soon passed and my cigarettes started tasting really bad. I was hardly smoking at all except in certain situations such as staying at home and reading when the environmental cues would trigger chain-smoking behavior. So after two weeks on the Chantix I decided to buy nicotine-free cigarettes (Quest was the brand I found in New York) and stop inhaling nicotine entirely. I still had the gum and the chew if I felt a need for nicotine–I just would not inhale it anymore.
This illustrates a fifth harm reduction technique: Break the bad habit (undesired behavior–or what the steppers call “addiction”) into component parts and work on one piece at a time.
I have been smoking the nicotine free cigarettes for two days now and I have absolutely NO desire to use the gum or the chewing tobacco–the thought of either makes me nauseous as I type. I have no desire for my Buglers either–now that is a change since I have been smoking Bugler about 20 years now–and I have been smoking something or other every single day for the past 35 years.
Yesterday was my first nicotine free day in 35 years and today is my second.
So I have taken one step towards the final change–I have gotten free of the nicotine addition. I only had some withdrawal about 12 hours after going nicotine free.
Now the thing is to stop the smoking part of the habit. I have cinnamon sticks and I have been chewing on them sometimes instead of a cigarette for the past couple of weeks–it is not a bad substitute. I have also been sucking on Hall’s cough drops. These two techniques comprise a sixth harm reduction technique–substitute a less problematic behavior.
And what is the final goal? Total abstinence? I think not. I would still like to enjoy an occasional cigar now and then. And I think that is okay–because cigars were never a habit for my like the cigarettes. I smoked only pipes and cigars from age 15 to 20–only when I went to college did I start the cigarettes.
Following the Chantix plan instead of using Chantix with my own plan would not have worked for me at all. When people tell me how bad smoking is then I want to smoke. It is only when people tell me that they want me to stick around for a long time because they like me that I want to quit, And total abstinence after one week of Chantix like Pfizer says? That would not work for me. And the money calculator? Hell–taking Chantix and buying nicotine free cigs is costing me roughly nine times as much as smoking Bugler.
So that is why My Own Plan works for me.