Phase 4
N=105
Bupropion for ADHD in Adolescents With Substance Use Disorder
Attention Deficit Hyperactivity Disorder · Nicotine Dependence · Cannabis Use Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00936299 ↗Enrolled (actual)
105
Serious AEs
3.8%
Results posted
Dec 2019
Primary outcome: Primary: Change in ADHD Rating Scale (ADHD-RS) Total Score — -14.2; -13.8 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Bupropion (Drug); Placebo (Other)
- Age
- Pediatric, Adult · 13+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in ADHD Rating Scale (ADHD-RS) Total Score |
-14.2; -13.8 | — |
| PRIMARY Change in Number of Days of Cigarette Smoking in Past 28 Days |
-4.1; -2.7 | — |
| SECONDARY Change in Number of Days of Cannabis Use in Past 28 Days |
-4.7; -6.5 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00936299). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.