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Impact of attention-deficit/hyperactivity disorder (ADHD) treatment on smoking cessation intervention in ADHD smokers: a randomized, double-blind, placebo-controlled trial.

OBJECTIVE: High smoking rates in adults with attention-deficit/hyperactivity disorder (ADHD) and nicotine's amelioration of ADHD suggest that effective ADHD treatment might facilitate abstinence in smokers with ADHD. The present study evaluated if using osmotic-release oral system methylphenidate (OROS-MPH) to treat ADHD enhances response to smoking cessation treatment in smokers with ADHD. METHOD: A randomized, double-blind, placebo-controlled, 11-week trial with a 1-month follow-up was conducted at 6 clinical sites between December 2005 and January 2008. Adults (aged 18-55 years) meeting DSM-IV criteria for ADHD and interested in quitting smoking were randomly assigned to OROS-MPH titrated to 72 mg/d (n = 127) or placebo (n = 128). All participants received brief weekly individual smoking cessation counseling for 11 weeks and 21 mg/d nicotine patches starting on the smoking quit day (day 27) through study week 11. Outcome measures included prolonged smoking abstinence and DSM-IV ADHD Rating Scale (ADHD-RS) score. RESULTS: Of 255 randomly assigned participants, 204 (80%) completed the trial. Prolonged abstinence rates, 43.3% and 42.2%, for the OROS-MPH and placebo groups, respectively, did not differ significantly (OR = 1.1; 95% CI, 0.63-1.79; P = .81). Relative to placebo, OROS-MPH evidenced a greater reduction in DSM-IV ADHD-RS score (P < .0001) and in cigarettes per day during the post-quit phase (P = .016). Relative to placebo, OROS-MPH increased blood pressure and heart rate to a statistically, but not clinically, significant degree (P < .05); medication discontinuation did not differ significantly between treatments. CONCLUSIONS: Treatment for ADHD did not improve smoking cessation success; OROS-MPH, relative to placebo, effectively treated ADHD and was safe and generally well tolerated in this healthy sample of adult ADHD smokers. TRIAL REGISTRATION: clinical Identifier: NCT00253747.

Pubmed ID: 20492837


  • Winhusen TM
  • Somoza EC
  • Brigham GS
  • Liu DS
  • Green CA
  • Covey LS
  • Croghan IT
  • Adler LA
  • Weiss RD
  • Leimberger JD
  • Lewis DF
  • Dorer EM


The Journal of clinical psychiatry

Publication Data

December 30, 2010

Associated Grants

  • Agency: NIDA NIH HHS, Id: K24 DA022288
  • Agency: NIDA NIH HHS, Id: K24 DA022288
  • Agency: NIDA NIH HHS, Id: U10 DA013732-05
  • Agency: NIDA NIH HHS, Id: U10-DA013035
  • Agency: NIDA NIH HHS, Id: U10-DA013036
  • Agency: NIDA NIH HHS, Id: U10-DA013046
  • Agency: NIDA NIH HHS, Id: U10-DA013732
  • Agency: NIDA NIH HHS, Id: U10-DA015831

Mesh Terms

  • Administration, Oral
  • Adult
  • Attention Deficit Disorder with Hyperactivity
  • Central Nervous System Stimulants
  • Combined Modality Therapy
  • Counseling
  • Delayed-Action Preparations
  • Diagnostic and Statistical Manual of Mental Disorders
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Female
  • Follow-Up Studies
  • Humans
  • Male
  • Methylphenidate
  • Middle Aged
  • Nicotine
  • Smoking
  • Smoking Cessation
  • Treatment Outcome