Bupropion for ADHD in Adolescents With Substance Use Disorder
Condition: Attention Deficit Hyperactivity Disorder; Nicotine Dependence; Cannabis Use Disorder
MeSH terms: Hyperkinesis; Substance-Related Disorders; Tobacco Use Disorder; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      Attention deficit hyperactivity disorder (ADHD) is one of the most common co-occurring
      psychiatric disorders (30-50%) in adolescents with substance use disorders (SUD). Yet, little
      is known about the safety and efficacy of medications for ADHD in adolescents with SUD, since
      such youths have been excluded from most medication trials. Clinicians are therefore
      understandably reluctant to treat ADHD in substance abusing adolescents, often first
      referring such youths to substance treatment. Untreated ADHD is associated with poorer
      substance treatment outcomes. We address this research gap by proposing a randomized
      controlled trial of bupropion vs placebo in 130 adolescents (13-19 years) with Diagnostic and
      Statistical Manual (DSM IV) ADHD, nicotine dependence and cannabis use disorder (not
      excluding other SUD). Participants in both bupropion and placebo treatment groups will
      receive weekly individual manualized-standardized cognitive behavioral therapy (CBT)
      targeting SUD (at no cost to them) throughout the 16 weeks of the medication trial. Bupropion
      also is effective in treating nicotine dependence in adults; the majority of adolescents with
      marijuana and other drug abuse also smoke tobacco. More recent research in adults indicates
      that bupropion may reduce craving and use of other substances of abuse (e.g. methamphetamine,
      cocaine). It's possible impact on cannabis use disorder (the addiction for which most teens
      are referred to treatment) has not yet been evaluated. However since all drugs of abuse have
      a final common pathway leading to addiction via action in the so called brain reward system
      (ventral tegmental area (VTA), accumbens) -an important secondary aim is to evaluate
      bupropion's potential impact on craving and use of marijuana (MJ) in addition to its known
      similar action on nicotine.
    

Detailed description: 
      Research has shown that bupropion is a safe and effective treatment for both ADHD and
      nicotine dependence in individuals without SUD, and newer research provides empirical support
      for its unique pharmacotherapeutic properties and potential for treating other addictive
      disorders (e.g., methamphetamine dependence, pathological gambling). No controlled studies
      have yet evaluated bupropion's safety and efficacy for ADHD and SUD (including nicotine and
      cannabis) in adolescents. The lack of research on the safety and efficacy of medications in
      adolescents with SUD and psychiatric comorbidities contributes to a serious lack of
      integrated treatment for commonly co-occurring mental health and substance problems in
      community-based adolescent drug treatment programs. This then contributes to poorer treatment
      outcomes and prognosis for the large number of comorbid youths with substance abuse and
      mental health problems that significantly impact public health. The specific aims of the
      proposed study will address this research gap by conducting a 16-week randomized controlled
      trial of bupropion vs. placebo to evaluate the safety and efficacy of this low abuse
      potential medication on ADHD, nicotine dependence, and cannabis use disorders (not excluding
      other SUD) in 130 adolescents (13-19) receiving concurrent outpatient substance treatment
      (CBT). The study design and analytic approach will enable assessment of the complex
      inter-relationship between change in ADHD, depression/dysphoria (and other psychiatric
      symptoms) and change in nicotine, cannabis and other substance use within and between
      treatment groups. Thus, the study addresses important research gaps in at least two priority
      areas of the National Institute on Drug Abuse/ National Institutes of Health(NIDA/NIH)
      research agenda: 1) research on effective treatments for adolescents with addiction and
      psychiatric comorbidity, and 2) medications development research for nicotine and cannabis
      use disorders in adolescents.
    

Intervention name(s): Bupropion; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Bupropion (target dose 300 mg/day) + cognitive behavioral therapy; matched placebo + cognitive behavioral therapy
Other intervention name(s): Sugar Pill
Intervention MeSH terms: Bupropion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Adolescents; Substance Use Disorder; Attention Deficit Hyperactivity Disorder; Cognitive Behavioral Therapy