Testing Methylphenidate for Smoking Abstinence
Condition: Smoking
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      Once enrolled in study, the subject will be put in one of 2 groups by chance (as in the flip
      of a coin). They will either receive methylphenidate or a placebo. Everyone in study will
      receive nicotine dependence counseling based on the intervention manual "Smoke Free and
      Living It". Everyone will be asked to complete weekly study visits for 8 weeks and one
      follow-up phone call at week 16 and a final study visit at week 24. The target quit day is
      the day after visit 4 (week 2 + 1 day). In the first two weeks after starting study
      medication they will slowly build up to 3 pills a day. For weeks 2 through 8 they will
      continue to take 3 pills a day.
    

Intervention name(s): Methylphenidate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 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)
Other intervention name(s): Methylphenidate, Osmotic Release methylphenidate (OROS-MPH)
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: nicotine dependence; tobacco dependence