Clinical trial: Interest in Smokeless Tobacco Product as a Substitution for Cigarettes in Current Smokers (NCT01800500)

Eligibility criteria:
Inclusion Criteria:

          -  Must report currently smoke at least 10 cigarettes per day and been smoking for at
             least 1 year

          -  Must not be planning to quit smoking in the next 30 days, nor tried to quit in the
             last 30 days

          -  Must be able to read and speak English

          -  Should not concurrently using other tobacco products or nicotine medications

          -  Willing to try new tobacco products and substitute other brands of cigarettes

          -  Not current participating in any other ongoing research study

          -  Must be in good general health

          -  Medically eligible to receive nicotine replacement products (based upon the New York
             State [NYS] Smokers Quit line eligibility criteria)

               -  No history of heart attack or stoke in last 2 weeks

               -  No current use of Zyban, bupropion, Wellbutrin, or Chantix/varenicline, or other
                  smoking cessation medication

               -  No history of chest pains or angina in past month

               -  No report of physician diagnosed arrhythmia/irregular heartbeat, fast heartbeat,
                  abnormal heart rate, or use of pacemaker

               -  No current report of physician diagnosed heart disease/coronary artery disease,
                  high blood pressure (systolic blood pressure [SBP] = 160; diastolic blood
                  pressure [DBP] = 100), stomach ulcer, diabetes, or taking pills for depression or
                  asthma

               -  No self-reported chronic dental problems that would interfere with using oral
                  products

               -  No use of an electronic cigarette (e-cigarette) in the past 30 days

               -  No known sensitivity to glycerol, propylene glycol, or glycerin

          -  For females, not currently pregnant or breastfeeding; nor planning to become pregnant
             during the follow-up interval

          -  Prospective participants must also pass screening tests for substance use,
             administered at the orientation session, to be entered on study; substance use will be
             assessed using a Clinical Laboratory Improvement Amendments (CLIA)-waived 7-drug urine
             screen (detecting presence of tetrahydrocannabinol [THC], opiates, amphetamine,
             barbiturates, methamphetamine, phencyclidine [PCP], and lysergic acid diethylamide
             [LSD]); participants must test negative on all 7 to be put on study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 27-year-old woman comes to the dermatology clinic with skin rash and oral ulcers.  The rashes are mildly itchy. The patient has no other medical conditions and takes no medications.  Vital signs are normal.  On examination, there are pink papules symmetrically distributed over the anterior surfaces of the shins and ankles. There are some white ulcerated papules on her buccal mucosa. She is in relationship with her boyfriend and has only one sexual partner. Her boyfriend uses condoms. She smokes 1 to 2 cigarettes a day and drinks a beer daily. Biopsy reveals prominent hyperkeratosis with a thickened granular layer.  There is an infiltration of mononuclear cells in the superficial dermis that involves the overlying epidermis. The rete ridges have a sawtooth appearance.

Patient description (patient's own words): I went to the dermatologist because I had rashes on my skin and ulcers in my mouth. The rashes were not that itchy. I don't get it! I'm 27, I don't take medication, nor I don't have any other illnesses. My vitals were normal. My doc told me there were pink spots on the back of my throat. I'm heterosexual and have been only with my boyfriend and he uses condoms. I smoke 1 or 2 cigarettes a day and I drink a beer to accompany it. I had a biopsy and it showed some thick and grainy skin texture. The doc said it's an immune reaction.

Does the patient match the trial criteria? Contradiction