Clinical trial NCT00549640 (phase 2, status: completed)
Conditions: smoking
ICD codes: O99.334, O99.335, Y93.G2, O99.330, O99.331, O99.332, O99.333
Drugs: methylphenidate, placebo
SMILES: [H][C@@](C(=O)OC)(C1=CC=CC=C1)[C@@]1([H])CCCCN1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
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.