Testing Methylphenidate for Smoking Abstinence
Condition: Smoking
MeSH terms: Tobacco Use Disorder
Intervention: Methylphenidate; Placebo
Intervention description: 54 mg Methylphenidate per day for 8 weeks. Allowing for a ramp up in the first two weeks (starting dose is 18 mg/day).; non-active (sugar pill)designed to be a look-alike to the methylphenidate. Given at the same frequency and dosage look-alike to the active comparator (methylphenidate 54 mg)
Intervention MeSH terms: Methylphenidate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: nicotine dependence; tobacco dependence

Summary:

      Cigarette smoking continues to be a major public health problem. Tobacco dependence
      interventions, as recommended by the USPHS Clinical Practice Guideline are not effective for
      all smokers. A need exists for new medications to treat various aspects of tobacco
      dependence, such as the reinforcing effects of nicotine, relief of nicotine withdrawal
      symptoms and prevention of early relapse. The neurobiology of the effect of methylphenidate
      is similar to that of the reinforcing effects of nicotine. In a small previous study,
      methylphenidate was reported to improve nicotine withdrawal symptoms and short term quit
      rates. Methylphenidate is well tolerated, has low abuse potential, and is less expensive
      compared to other tobacco dependence interventions. ConcertaTM, a long acting preparation of
      methylphenidate, is administered once a day, has similar bioavailability as the generic drug
      administered 3 times a day and has an overall similar or improved efficacy compared to
      generic methylphenidate. We plan to obtain preliminary efficacy data in a randomized,
      placebo-controlled phase II study assessing the effect of methylphenidate in cigarette
      smokers for increasing 7-day point prevalence smoking abstinence at end of treatment and
      7-day point prevalence and prolonged smoking abstinence at 6-months. Critical and systematic
      evaluations of newer, innovative, and well-tolerated treatments to help treat tobacco use and
      dependence will provide a wider choice of therapeutic agents to smokers wishing to become
      abstinent from tobacco use.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Are between 18 to 65 years of age

          2. Have smoked cigarettes daily for the past 6-months and are currently smoking > 10
             cigarettes/day

          3. Are willing to make an attempt to stop smoking

          4. Are able to participate fully in all aspects of the study

          5. Have been provided with, understand, and have signed the informed consent

        Exclusion Criteria:

          1. Have clinically significant levels of current depression as assessed by CESD and
             determined by the physician; or have a life-time diagnosis of bipolar disorder,
             schizophrenia or dementia as determined by physician investigator

          2. Are currently (in previous 30 days) using any tobacco treatment program (i.e.,
             behavioral therapy, nicotine replacement therapy, bupropion SR, varenicline, clonidine
             or nortriptyline)

          3. Have used an investigational drug within the 30 days prior to enrolling in this study

          4. Alcohol or drug abuse or dependence within the past year as assessed by the study
             investigators using CAGE questionnaire and the Drug Abuse Screening Test 20 (DAST-20)

          5. Are pregnant, lactating, or of child bearing potential, likely to become pregnant
             during the medication phase and not willing to use contraception. The following birth
             control measures are acceptable: approved hormonal contraceptive medications or
             devices, approved intra-uterine contraceptive devices, the use of two combined barrier
             methods (diaphragm with spermicide or condom with spermicide), birth control pills,
             injections, intrauterine device [IUD], abstinence, or surgical sterilization of
             subject or of monogamous partner.

          6. Have a history of any major cardiovascular event in the past 6-months including
             unstable angina, acute MI or coronary angioplasty

          7. Have clinically significant acute or chronic, progressive or unstable neurologic
             (dementia, delirium or seizure disorder), hepatic, renal, cardiovascular, respiratory
             or metabolic disease that would limit participation in the study

          8. Are currently on the following prescribed medications known to interact with
             methylphenidate and not able to stop the medication during the study period:
             stimulants, warfarin, anticonvulsants, antidepressants, antipsychotics, monoamine
             oxidase inhibitors, clonidine, theophylline and pseudo-ephedrine

          9. Uncontrolled hypertension (>160/100) or tachycardia (Heart rate >110)

         10. Have another house-hold member or relative participating in the study

         11. Have known allergy to methylphenidate or its constituents

         12. Have a specific medical condition where use of methylphenidate is contraindicated:
             narrow angle glaucoma, motor tics, family history or diagnosis of Tourette's syndrome,
             and history of GI obstruction (including history of strictures, adhesions, or
             abdominal surgery)

         13. have an ECG with significant arrhythmias or abnormal conduction, which in the opinion
             of the physician investigator preclude participating in the study.