This proposal for a Mid-Career Investigator Award in Patient-Oriented Research (K-24) describes a plan in patient-oriented research, mentor ship and career development in the area of clinical trials involving adolescents with alcohol use disorders (AUDS) and comorbid attention-deficit hyperactivity disorder (ADHD) and other psychopathology. The mentor ship plan includes organized, structured efforts in recruiting appropriate trainees, including child and adolescent psychiatrists, for mentor ship and involvement and development of specific training experiences for these trainees. The proposed career development plan includes course work and supervision in methodology and statistics related to clinical trials and psychopharmacology in adolescents with ADHD and AUDS. To assist both career development and mentor ship efforts, this application includes a proposal for a double-blind, placebo-controlled study of bupropion Sustained Release (SR) in adolescents with comorbid AUD and ADHD.
The specific aim of the study is to compare the efficacy of bupropion SR vs. placebo in the treatment of adolescents with comorbid AUD and ADHD for ADHD symptoms, drinking and other substance use behaviors. There have been few studies that have examined pharmacological treatment in this comorbid population. As psycho stimulants present a potential risk to adolescents with comorbid AUD/ADHD due to abuse or diversion, other medications need to be considered. One hundred (100) adolescents, ages 14-18, will be recruited from community treatment programs. After screening, informed consent and baseline assessment to confirm diagnoses of an AUD and current ADHD, the adolescents will be randomized into two groups, which will receive either placebo or bupropion SR (titrated to a dose of 300 mg/day). During the 16-week trial, weekly or bi-weekly follow-up assessments will assess efficacy for both ADHD and AUD symptomatology and safety. The results and conduct of this study, along with organized, structured mentor ship activities and the development of advanced skills in clinical trials, will serve to advance the applicant's long-term goals of conducting both pharmacological and multi-modal clinical trials in adolescents with AUDs or Substance Use Disorders (SUDS) and comorbid psychiatric disorders. It will also provide opportunities for mentor ship to trainees and junior colleagues. These complementary efforts will advance the field through both research and training.
