Official Title: “Bupropion for ADHD in Adolescents With Substance Use Disorder”

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 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 (VTA, accumbens) -an important secondary aim is to evaluate bupropion's potential impact on craving and use of MJ in addition to it's known similar action on nicotine.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: March 2013

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 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(s) in this Clinical Trial

• Drug: Bupropion, Cognitive Behavioral Therapy
  • Target dose 300 mg/day Cognitive Behavioral Therapy

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: bupropion + cognitive behavioral therapy
  • Adolescents with ADHD, nicotine dependence, and cannabis use disorders receive placebo + CBT.

Primary Measures

• To assess the safety and efficacy of bupropion versus placebo in treating ADHD in adolescents with nicotine and cannabis use disorders. To assess the safety and efficacy of bupropion versus placebo in reducing nicotine and cannabis use disorders.
  • Time Frame: end of trial
    Safety Issue?: Yes

Secondary Measures

• To evaluate the impact of bupropion compared to placebo on nicotine craving, cannabis use, cannabis craving, and depressive symptoms in adolescents with ADHD, nicotine and cannabis use disorders.
  • Time Frame: end of trial
    Safety Issue?: Yes

Inclusion Criteria:

• Adolescents aged 13-19 meets DSM-IV criteria for nicotine dependence (and/or cut off score of >3 on the mTFQ meets DSM-IV criteria for cannabis abuse or dependence on the KSADS-PL
• Has a DSM-IV ADHD Symptom Checklist score of >/-22 (adolescent) and if non-emancipated minor, >/-22 derived from a joint adolescent and parent/guardian checklist medically healthy if female and of child bearing potential, agree to use acceptable method of birth control throughout study participation
-

Exclusion Criteria:

• Current or past psychosis bipolar I or II disorder first degree relative with bipolar 1 disorder lifetime history of eating disorder lifetime history of seizure disorder or traumatic brain injury with LOC > 15 minutes Other chronic or serious medical illness previous clinically significant adverse reaction to bupropion The need to take psychotropic medications at the time of study entry; cannot have been on psychotropic medication for at least one month prior to study entry Current use of other psychotropic medications including NRT Current opiate dependence

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 13 Years

Maximum Age for this Clinical Trial: 19 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: National Institute on Drug Abuse (NIDA)

Overall Clinical Trial Officials and Contacts

Paula D Riggs, M.D. Principal Investigator University of Colorado, Denver  

Overall Contact: Michelle A Lohman, BS, RN 303 935-5892 michelle.lohman@ucdenver.edu

Information obtained from ClinicalTrials.gov on February 08, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00936299

Study ID Number: DA022284

ClinicalTrials.gov Identifier: NCT00936299

Health Authority: United States: Federal Government