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
Intervention: Bupropion; Placebo
Intervention description: Bupropion (target dose 300 mg/day) + cognitive behavioral therapy; matched placebo + cognitive behavioral therapy
Intervention MeSH terms: Bupropion
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 105.0
Sex: All
Minimum age: 13 Years
Maximum age: 19 Years
Healthy volunteers: No
Keywords: Adolescents; Substance Use Disorder; Attention Deficit Hyperactivity Disorder; Cognitive Behavioral Therapy

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Between the ages of 13 and 19, with a parent or legal guardian available to complete
             parental assessments for minors;

          -  Meet DSM-IV diagnostic criteria for ADHD on the K-SADS-PL;

          -  Schedule for Affective Disorders and Schizophrenia score ≥ 22 on the DSM-IV ADHD
             symptom checklist;

          -  Meet DSM-IV criteria for nicotine dependence (and/or cut off score of >3 on modified
             Fagerstrom);

          -  Meet DSM-IV criteria for cannabis abuse or dependence on the Kiddie-Sads-Present and
             Lifetime (K-SADS-PL);

          -  Have used marijuana at least 5 of the past 30 days;

          -  Have used nicotine at least 15 days out of the past 30 days;

          -  Be medically healthy;

          -  If female, subjects must use an effective birth control method if sexually active.

        Exclusion Criteria:

          -  Current or past psychosis;

          -  Bipolar I or II disorder;

          -  A first-degree relative with bipolar I disorder;

          -  A lifetime history of seizure disorder;

          -  Any other chronic or serious medical illnesses;

          -  A lifetime history of eating disorder;

          -  Current pregnancy;

          -  Previous clinically significant adverse reaction to bupropion;

          -  The need to take other psychotropic medications at the time of study entry. Patients
             may have had previous psychotherapy or pharmacotherapy for ADHD or other co-morbidity
             but cannot have been on psychotropic medication for at least one month prior to study
             entry;

          -  Active participation in substance abuse treatment or mental health treatment
             (including outpatient, day-treatment, residential, or inpatient) within 28 days prior
             to signing consent;

          -  Non-English speaking (due to the difficulty in translating the additional materials
             given to the subjects);

          -  Cognitively impaired or of low intelligence;

          -  Breastfeeding;

          -  Current use of other psychotropic medications including nicotine replacement therapy;

          -  Current opiate dependence.