Bupropion for ADHD in Adolescents With Substance Use Disorder - NCT00936299-80210 (Clinical Trial 301298)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy301298.aspx
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| City: |
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Denver |
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State:
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CO |
| Zip Code: |
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80210 |
| Conditions: |
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Attention Deficit Hyperactivity Disorder - Nicotine Dependence - Cannabis Use Disorder |
| Purpose: |
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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.
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| Study summary: |
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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. |
| Criteria: |
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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
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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 |
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| Study is available at: |
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University of Colorado Denver, Adolescent Clinical Research
Denver, CO 80210
United States
Primary Contact:
Michelle A Lohman, BS, RN
Email: michelle.lohman@ucdenver.edu
Phone: 303 935-5892
Secondary Contact:
Michelle A Lohman, BS, RN
Email: michelle.lohman@ucdenver.edu
Phone: 303 935-5892 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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