Status:
COMPLETED
Bupropion for ADHD in Adolescents With Substance Use Disorder
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Attention Deficit Hyperactivity Disorder
Nicotine Dependence
Eligibility:
All Genders
13-19 years
Phase:
PHASE4
Brief 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 ...
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 pharm...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT00936299
Start Date
January 1 2009
End Date
May 1 2013
Last Update
December 23 2019
Active Locations (1)
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1
University of Colorado Denver, Adolescent Clinical Research
Denver, Colorado, United States, 80210