Welplex Stop Smoking Clinics

Retrospective Study

Retrospective Study for Anticholinergic Blockade in Smoking Cessation

Abstract: A one year multi­center retrospective study examined the efficacy of Anticholinergic Blockade treatment for nicotine addiction. Two hundred patients were surveyed one year post treatment using the Welplex patented protocol. Data collected included current status of nicotine use (smoking vs. not smoking), or if currently smoking the length of abstinence post treatment. Other data collected included content of smoking pre­- and post­treatment, qualitative data regarding levels of cravings for nicotine, and comparative success of other nicotine cessation treatments.

Background: The Welplex™ patent uses an anticholinergic  blockade of central and peripheral nicotine receptors for the treatment of nicotine addiction. Intramuscular  and subcutaneous injections of atropine,  scopolamine and  promethazine  are  used  to block central nicotine receptors in the  brain. The  blockade is maintained for an additional 2 weeks through oral anticholinergic medications. Behavioral modification is accomplished through a  series of video presentations and  printed  material focused  toward the mechanical and  habitual aspects of smoking. The patient is made aware of the mental triggers associated with cigarette smoking and given a series of diversions and alternative actions to aid  in  the  mental habit portion of nicotine  addiction. These  messages are delivered in both a conscious and subliminal manner greatly adding to the overall success in smoking cessation.

Previously published data from 500 patients seen in a primary care setting treated with  the anticholinergic medications showed successful abstinence from tobacco of 86% after two  months and  over  40% after  a  full year ¹. This earlier  study did  not  account  for patients lost to follow ­up  and  was passive  in  the data  collection process. The  current study examined the efficacy of the anticholinergic blockade by polling 200 active patients treated one calendar year earlier. The  Welplex  approach is unique  because  it is directed  at mmediate saturation of the nicotine  receptors. This saturation results in  nicotine  withdrawal without the characteristic  cravings and  irritability. The  tremendously unpleasant side  effects of nicotine withdrawal are eliminated, thus leading to a substantial increase in the success rate of cure from nicotine dependency.

Methods: the Welplex call center was utilized to contact a patient list provided from two  treatment clinics. The  treatment list was  essentially chosen  at random approximately taking  the  total clinic  treatment population for the  months of February through April 2004  until a  total of 200  patient responses were obtained. All  patient  responses were documented on a standardized survey sheet . Data collected was subdivided based on the patient’s current smoking status (smoking or not smoking). Those patients not smoking were polled as to the overall effectiveness of the Welplex Protocol using a scaled 1­10 complication / craving experience. Those patients who failed treatment and had resumed smoking were polled as to the length of abstinence, current and past level of nicotine use, factors contributing  to the  resumption of nicotine use  and  overall  impression of the Welplex protocol. Other data collected from both groups included alternate methods of Retrospective Study for Anticholinergic Blockade in Smoking Cessation Welplex™ Stop Smoking Clinics Page 2  of 4 smoking  cessation used  in the  past and relative  effectiveness compared to the Welplex protocol.

Results: Results are summarized in Table 1. The patients who failed the treatment were subdivided  by months of smoking  cessation (month 1­12). The  total of patients who remained  nicotine  free for 60  days was 156/200 (88%). Total  abstinence  for 1  year remained at 56% (112/200). There was a linear progression from months 3 to 12 with the  greatest failure proportion occurring by month six.

The greatest factor noted in the failed group for recurrence of smoking was stress related issues (family or work  related). Of the early failures (less than 2  months) the  most prominent reason stated was lack  of motivation. Concurrently, the  success of the treatment was rated  high even in  the treatment failure  population in  a  majority of the patients (82%).

Quantitative  consumption of nicotine  was also decreased  in the  treatment failure population. The average nicotine consumption between the two groups (smoking vs. non­ smoking  was equal (29.2  cig/day vs. 28.8  cig/day p=.05). The  post treatment  failure group decreased overall cigarette consumption by 56% with the average current cigarette consumption at 16.1.

Discussion: Nicotine  is a  highly toxic  alkaloid  and  is the  principal pharmacologically active component in cigarettes and cigars. It is ubiquitous in western society and is found in  measurable  quantities in  smokers and  non­smokers alike.  Nicotine exerts diverse psychopharmacologic  effects and  is thought to  be  the  key component in  tobacco responsible  for habitual smoking¹. The  initial site  of nicotine's actions is the  nicotinic acetylcholine receptor (nAChR). Nicotine's diverse  psychopharmacologic  effects likely relate  to  nAChR modulation of dopaminergic,  serotonergic,  adrenergic,  glutamatergic, and endogenous opiate peptide pathways^2, 3.

Tobacco was brought from the  New World  with Columbus. Reports from the  crew describe the natives smoking the leaves of the tobacco plant and exhibiting a pleasurable reaction. The use of tobacco soon spread throughout the world, despite severe opposition and often draconian penalties. Currently in the United States approximately 25­27 % of the  adult population smoke. In other  parts of the world tobacco use  exceeds 40% with concurrent increases in associated morbidity. Tobacco use was officially listed as form of drug dependence in the report of the Surgeon General in 1988¹.

Nicotine Addiction

The addictive qualities of nicotine are generally accepted; however the actual severity of the  addiction is often ignored. Fully 80% of adult smokers  express a  desire  to stop smoking. The success rates for smoking cessation vary with approach. The classic “cold turkey” has the lowest success rate with only 5%­8% of smokers succeed. Of those who actually succeed, an average of 7 attempts are needed to become smoke free. The single most stated reason for not stopping or even attempting to quit smoking is the fear of the withdrawal symptoms^1,2,4

While addiction to nicotine is different from that of cocaine and amphetamine addiction, nicotine appears to involve similar pathways in the pleasure/reward centers of the brain. The  pathways of the  central nervous system (CNS) are  complex, but are  believed  to involve  the  pleasure  centers of the  limbic system as well as pathways associated  with hunger (smokers are  on average 5­10% thinner than non­smokers4). Overall CNS  and peripheral nervous system (PNS) effects include stimulating  the  following  areas:  the adrenal medulla,  central nervous system, cardiovascular  system (from the  release  of catecholamines), gastrointestinal tract, salivary and bronchial glands, and the medullary  vomiting center ⁷.

Nicotine replacement therapy (NRT) became  available  in  the  70’s with only marginal increases in smoking  cessation approaching  10% ­ 15%. NRT carries with it its own problems and concerns. Individuals who continue to smoke while using NRT products are  at significantly increased risk  for nicotine  toxicity. In  addition, repeated  attempts with NRT are less successful after the first failure. As NRT’s only substitute the nicotine delivery system, the actual addiction to nicotine remains intact. It is presumed that this will allow  for modification of the  ritual  (i.e. habit) component of the  addiction with subsequent gradual withdrawal of the  nicotine.  Not  surprising, the  most common concern expressed  by smokers is the fear of developing dependence for the NRT itself after smoking is discontinued ⁴.

Various pharmacologic  neurotransmitter  modulators have  been used  as an adjunct for smoking withdrawal. Tricyclic antidepressants, anxiolytics, central receptor modulators, and direct nicotine agonist have all been used with varying degrees of success. Currently Welbutrin (Zyban), a serotonin, adrenaline uptake inhibitor has the highest success rate of 22%. The common factor of the pharmacologic treatments has been the diminution of the  nicotine cravings and the subsequent reduction of the  distress (both physical and psychological) experienced by the individual.

Previous studies on the use of ACB in Nicotine addiction

In 1987 a patent was issued for the use of anticholinergic blockade in the treatment of nicotine addiction. A subsequent patent was developed in 2000 which expanded the  original work to include a regimen of medications to provide a low level of anticholinergic effects for the duration of nicotine withdrawal in conjunction with behavioral modification. The current patent uses three drugs in a series of injections which use the anticholinergic properties of these medications to block central nicotine receptors in the brain. The data from 500 patients seen in a primary care setting treated with the anticholinergic medications showed successful abstinence from tobacco of 86% after two months and over 40% after a full year. This approach was unique in that it was directed at immediate saturation of the nicotine receptors resulting in withdrawal without the characteristic cravings and irritability. Patients report that after the treatment their cravings for nicotine simply weren’t there. The tremendously unpleasant side effects of nicotine withdrawal were eliminated thus leading to a substantial increase in the success rate of cure from nicotine dependency.

Anticholinergic Blockade Vs. Conventional Treatments

Anticholinergic blockade of nicotine receptors offers clear advantages to other treatment modalities. Most notable is the immediate cessation of nicotine cravings instead of the gradual withdrawal of Nicotine Replacement Therapies and Serotonergic treatments (Zyban). Compared to the most successful conventional modality, the Welplex methodology offers the potential success over four times that of Zyban and six times that of abrupt nicotine cessation or NRT. As previous studies have shown it is the cravings as well as the fear of cravings responsible for the failures of smoking cessation. The Welplex method’s overwhelmingly high success rate is directly correlated to the immediate reduction in cravings for nicotine. This allows for modification in behavior without the compounded factors of physical and psychological cravings.

Summary

This study clearly demonstrates the advantages and overwhelming success of the Welplex method for the treatment of nicotine addiction. While nicotine addiction remains one of medicine’s most difficult and frustrating problems, the Welplex method offers a novel approach opening new avenues for nicotine treatment.