Combination Nicotine Patch / Lorcaserin for Smoking Cessation
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Intervention: lorcaserin; nicotine patch; placebo lorcaserin
Intervention MeSH terms: Nicotine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 97.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Nicotine addiction; Cigarette smoking; Smoking cessation; lorcaserin; Belviq; Nicotine patches

Summary:

      This study plans to compare the efficacy of the nicotine patch / lorcaserin combination
      treatment vs. the nicotine patch alone in terms of leading to a reduction in smoking behavior
      and withdrawal symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18-65 years old;

          -  Smoke an average of at least 10 cigarettes per day;

          -  Have smoked at least one cumulative year;

          -  Have an expired air CO reading of at least 10ppm;

          -  Body weight of >50 kg (110 lbs.)

          -  Able to read and understand English;

          -  Express a desire to quit smoking in the next thirty days.

        Exclusion Criteria:

          -  Hypertension (systolic >140 mm Hg, diastolic >100 mm Hg, coupled with a history of
             hypertension); subjects with no previous diagnosis of hypertension may have a
             screening blood pressure up to 160/100.

          -  Hypotension with symptoms (systolic <90 mm Hg, diastolic <60 mm Hg).

          -  Participants with a history of hypertension may, however, be allowed to participate in
             the study if the study physician or physician assistant determines that the condition
             is stable, controlled by medication, and in no way jeopardizes the individual's
             safety.

          -  Coronary heart disease, diagnosed by coronary angiogram;

          -  Lifetime history of heart attack;

          -  Cardiac rhythm disorder (irregular heart rhythm);

          -  Chest pain in the last month (unless history, exam, and ECG clearly indicate a
             non-cardiac source);

          -  Symptomatic cardiac (heart) disorder (including but not limited to valvular heart
             disease, heart murmur, heart failure);

          -  Diagnosis of liver disease or kidney disorder (except kidney stones, gallstones);

          -  Gastrointestinal problems (e.g. Celiac disease, Crohn's dx Ulcerative Colitis) or
             disease other than gastroesophageal reflux or heartburn;

          -  Active ulcers in the past 30 days;

          -  Currently symptomatic lung disorder/disease (including but not limited to chronic
             obstructive pulmonary disease (COPD), emphysema, and asthma);

          -  Brain abnormality (including but not limited to stroke, brain tumor, and seizure
             disorder);

          -  Migraine headaches that occur more frequently than once per week;

          -  Recent, unexplained fainting spells;

          -  Problems giving blood samples;

          -  Diabetes (unless controlled by diet and exercise alone and screening glucose is less
             than 180mg/dcl and HbA1c is less than 7%);

          -  Current cancer or treatment for cancer in the past six months (except basal or
             squamous cell skin cancer);

          -  HIV, Hepatitis B, or Hepatitis C

          -  History of tuberculosis or recent positive purified protein derivative (PPD) test

          -  Other major medical condition;

          -  Current psychiatric disease (with the exception of anxiety disorders, obsessive
             compulsive disorder (OCD) and ADHD);

          -  Suicidal ideating (thinking about ways to commit suicide) (within the past 10 years)
             or lifetime occurrence of attempted suicide;

          -  Current depression - The Patient Health Questionnaire (PHQ-9) for Depression will be
             used to screen for current (within 2 weeks) depression. Potential subjects who score
             >9 (or who score >0 on item #9 ("Thoughts that you would be better off dead, or of
             hurting yourself in some way") will be excluded from study participation, and, at the
             discretion of the study physician, referred to appropriate psychiatric treatment;

          -  Bulimia or anorexia;

          -  BMI of < 18.5 kg/m2;

          -  Prior use of fenfluramine or dexfenfluramine

          -  Use (within the past 30 days) of:

               -  Illegal drugs (or if the urine drug screen is positive for tetrahydrocannabinol
                  (THC), Cocaine, Amphetamine, Opiates, Methamphetamines, phencyclidine (PCP),
                  Benzodiazepines, or Barbiturates), Unless recent use of prescription Opiates,
                  Benzodiazepines for management of acute symptoms.

               -  Experimental (investigational) drugs;

               -  Psychiatric medications including antidepressants (selective serotonin reuptake
                  inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs),
                  tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs), St.
                  John's Wort), lithium, anti-psychotics or any other medications that are known to
                  affect smoking cessation (e.g. clonidine);

               -  Phentermine, triptans, tryptophan, linezolid, dextromethorphan, opiates,
                  tramadol, or dopamine agonists;

               -  Any agents that have documented correlation with increased incidence of
                  valvulopathy and/or pulmonary hypertension (e.g., cyproheptadine, trazodone,
                  nefazodone, amoxapine, tricyclic antidepressants, mirtazapine, pergolide,
                  ergotamine, methysergide) (or anticipated use during the study);

               -  Smokeless tobacco (chewing tobacco, snuff), pipes or e-cigarettes;

               -  Wellbutrin, bupropion, Zyban, Chantix, varenicline, nicotine patch, nicotine
                  replacement therapy or any other smoking cessation aid.

          -  Concurrent use of a serotonergic agent/combination associated with severe serotonin
             syndrome (within the past 30 days);

          -  Use of cigar, cigarillos, pipe, Hookah, dissolvable nicotine, snuff, chewing tobacco
             more than once per month.

          -  Use of e-cigarettes once per month or more.

          -  Self-report of consuming 4 or more alcoholic drinks on 1 or more days per week;

          -  Significant adverse reaction to lorcaserin or nicotine patch in the past.

          -  Current participation or recent participation (in the past 30 days) in another smoking
             study at the investigators Center or another research facility.

          -  Current participation in another research study.