About Us
Welplex Treatment
Clinic Location
Treatment Comparison
Introduction

Adverse Reactions

Contraindications

Initial Office Visit

Effectiveness

FDA Approval

Costs


Introduction

Since the introduction of nicotine into Europe by the Spaniards in the 1700's, there has been little that medical science has had to offer for effectively dealing with nicotine addiction. These treatments included: hypnosis, acupuncture, aversion therapy, nicotine replacement systems, antidepressants and a variety of herbal solutions. All of these have had little, if any, therapeutic value and recidivism has been generally high.


Smoking cessation therapy was initiated with the introduction of Nicotine Replacement Therapy. This involved the use of gum, lozenges, patches and even "look-a-like" fake cigarettes to deliver nicotine. Effectiveness of these systems has been shown to be only marginally better than cold turkey methods. In the 90's the focus of nicotine addiction shifted to various pharmacologic neurotransmitter modulators used as an adjunct for smoking withdrawal. Tri-cyclic antidepressants, anxiolytics, central receptor modulators, and direct nicotine agonists were used with varying degrees of success. Of these medications WellbutrinTM (ZybanTM), a serotonin adrenaline uptake inhibitor, is the best known. The common factor of the pharmacologic treatments is the diminution of the nicotine cravings and the subsequent reduction of the individual's physical and psychological distress.

Recently Pfizer has introduced a new medication for the treatment of nicotine addiction, ChantixTM . Chemically named varenicline, it is described as a novel A4 - B2 nicotinic acetylcholine receptor partial agonist. In simple terms this means that the drug binds competitively to the nicotine receptor and activates the central nervous mesolimbic dopamine system, believed to be the neuronal mechanism underlying reinforcement and reward experienced upon smoking. By this binding to the nicotine receptor it stimulates the reward-pleasure pathway as does nicotine but at a lower level. In addition, it also blocks the ability of Nicotine to activate the receptor. The effectiveness of ChantixTM was shown in multiple clinical trails with over 3,600 patients. In the ChantixTM trials patients were told to set a stop smoking date and begin medication one week prior to this date.

For complete information regarding the clinical trials see: Chantix .com.


Similarly, the WelplexTM patented method of anticholinergic blockade of the nicotine receptors is believed to activate the mesolimbic dopamine system. The Welplex patent uses an anticholinergic blockade of central and peripheral nicotine receptors for the treatment of nicotine addiction. This approach is unique because it is directed at immediate 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 reduced or eliminated, thus leading to a substantial increase in the success rate of cure from nicotine dependency. To document the Welplex claim, a retrospective study of 200 patients treated was initiated demonstrating an >80% efficacy at 2 months and 56% at one year (complete results available on this website).
Both Welplex
and ChantixTM act within the Central Nervous System to modulate the
cravings for nicotine. The success of the Welplex is believed to relate to the immediacy of the treatment with the cravings for nicotine satiated immediately with the treatment injections. This approach provides a more direct psychological as well as physiologic breaking of the nicotine reward pathways.
The Welplex protocol is administered by injection followed up by a 2 week oral regimen of medications. The ChantixTM protocol consists of medications taken by mouth for recommended period of 12 to 24 weeks.

Adverse Reactions

ChantixTM

WelplexTM

Nausea

Sleep Disturbance

Constipation

Flatulence (Gas)

Vomiting

Sleep Disturbance

Sedation

Dry Mouth

Blurred Vision

Constipation

Urinary Retention

Decreased Sweating

Confusion

Hallucinations (Rare)
















Contraindications

ChantixTM

WelplexTM

Late Stage Kidney Failure

Patients on dialysis

Cardio arrhythmia

Enlarged prostate

Narrow angle glaucoma

Bi-polar disorder

pregnancy

taking multiple mind-altering medications



Description of Treatments

Initial Office Visit

For both treatments, certain medical tests will be performed. An electrocardiogram (EKG), a lung function test, and a simple physical will be performed. Your medical history will be reviewed for any potential contraindications for the treatments. You will receive some counseling in changing your habits and dealing with social interactions in the form of a video and some collateral materials that you can take with you.

For patients receiving the ChantixTM Treatment
Following medical testing, you will receive a prescription for ChantixTM . The initial supply contains a blister pack for the first week where you will take one white tablet per day (0.5mg) for the first three days. For days 4-7 you will take two white tablets per day (0.5mg each). The seventh day should be the day you select to stop smoking. For weeks 2-4, you will take two blue tablets (1.0mg each). You should not smoke during this time. You should call us if you have any problems before resuming smoking.

ChantixTM works by blocking your nicotinic receptor sites, virtually eliminating physical withdrawal and physical urges.


At the end of each four week period, you should come back to our offices to discuss your progress with the medical staff. At each appointment, we will review your success or failure with the treatment and make any needed adjustments in your medications, if any.
This process will continue for 12 to 24 weeks.


We will also optionally enroll you in a Pfizer-run follow-up program called GetQuitTM. The GetQuitTM program offers a no-cost follow-up of your progress by telephone and on the web for up to 52 weeks. Details on this program can be obtained at www.Chantix.com.


For patients receiving the Welplex treatment
Following the medical testing, you will receive a series of injections that block your nicotinic receptors and virtually eliminate your physical withdrawal and physical cravings. You will leave the clinic as a non-smoker. The effect of the treatment is immediate. The medications can cause you to be light headed and so you will need a driver to take you home. You should not drive for 12 hours following the treatment and should not drive or perform any potentially dangerous activities until you know how the medications will effect you.

Eight to twelve hours following your treatment, you will start your follow-up medications. Follow the directions on the medication label. These medications will continue blocking your receptor sites for the next two weeks at which point, your dependency to nicotine should be broken.


For both treatments:
You should call the clinic with any problems or concerns. If you slip up and start smoking, let us know and we will advise you what to do next. If the treatment works for you, you will become a non-smoker. If you return to smoking, we will discuss alternate methods of stopping.



Effectiveness
Clinical studies are a general indicator of success. Your results may vary.

For Chantix
TM
Clinical studies indicated that 44% of patients taking the treatment remained non-smokers at 12 weeks and 29% at one year. The success rates were best for patients taking the treatment for over 12 weeks.


For Welplex
Clinical studies indicated that over 80% of patients taking the treatment remained non-smokers at 60 days following treatment and over 50% at one year.


FDA Approval

For ChantixTM

In May 2006 the Federal Food & Drug Administration (FDA) approved ChantixTM as a treatment for smoking cessation. Pfizer, the developer of ChantixTM released the treatment to the market in August 2006.

For Welplex
Each of the component medications in the treatment has been individually approved by the FDA for other uses. Using these medications for smoking cessation is referred to in the industry as using the medications "off-label". Using medications off-label is a common practice in the medical community. Minoxydil, BotoxTM and Aspirin treatment for heart disease are all examples of medications approved by the FDA for other uses that began as off-label treatments. Some physicians, however, disapprove of using any medications that have not been "officially" approved by the FDA for a specific use.

The primary medications in the Welplex treatment have been used in medicine for over 100 years. We have treated over 7,000 patients in the Atlanta clinic and many thousands more have been treated nationwide using this protocol with no adverse events.

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Costs

For ChantixTM

Your costs will vary depending on the length of time you elect to continue the ChantixTM treatments. You and the doctor will determine the best time for you to discontinue taking ChantixTM based on your situation. In clinical studies, patients remaining on ChantixTM longer had a higher level of success.

We chose a cost of $100.00 for the projection below. We called several local pharmacies where prices ranged from $95 to $125 for ChantixTM.

Total Cumulative Cost

Office Visit

Initial Visit

50

Testing & Counseling

173

ChantixTM Medication

weeks 1-4

100

323

Office Visit

50

ChantixTM Medication

weeks 5-8

100

473

Office Visit

50

ChantixTM Medication

weeks 9-12

100

623

Office Visit

50

ChantixTM Medication

weeks 13-16

100

773

Office Visit

50

ChantixTM Medication

weeks 17-20

100

923

Office Visit

50

ChantixTM Medication

weeks 21-24

100

1,073


For Welplex

Total Cumulative Cost

Office Visit

50

Testing & Counseling

173

Welplex Treatment

289

Welplex Medication

weeks 1-2

65

577


ChantixTM and GetQuitTM are registered trademarks of Pfizer.
ZybanTM and WellbutrinTM are registered trademarks of GlaxoSmithKline.

BotoxTM is a registered trademark of Allergan Pharmaceuticals.

WelplexTM is a registered trademark of Welplex, Inc.

Information for this document was obtained from www.Chantix.com and from www.welplex.com on 1/2/2007.

Cost figures for ChantixTM were obtained by calling local Atlanta pharmacies and approximating the cost.