Bupropion for ADHD in Adolescents With Substance Use Disorder
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| City: |
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Denver |
| State: |
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Colorado |
| 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 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.
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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 National Institute on Drug Abuse/ National Institutes of
Health(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.
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| Criteria: |
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Inclusion Criteria:
Subjects must 1) be between the ages of 13 and 19, with a parent or legal guardian
available to complete parental assessments for minors; 2) meet DSM-IV diagnostic criteria
for ADHD on the K-SADS-PL; 3) Schedule for Affective Disorders and Schizophrenia score =
or >22 on the DSM-IV ADHD symptom checklist; 4) meet DSM-IV criteria for nicotine
dependence (and/or cut off score of >3 on modified Fagerstrom); 5) meet DSM-IV criteria
for cannabis abuse or dependence on the Kiddie-Sads-Present and Lifetime (K-SADS-PL); 6)
have used marijuana at least 5 of the past 30 days; 7) have used nicotine at least 15 days
out of the past 30 days; 8) be medically healthy; 9) use of effective birth control method
if female and sexually active.
Exclusion Criteria:
Subjects with any of the following will be excluded:1) current or past psychosis; 2)
bipolar I or II disorder; 3) first-degree relative with bipolar I disorder; 4) lifetime
history of seizure disorder; 5) other chronic or serious medical illnesses; 6) lifetime
history of eating disorder; 7) current pregnancy; 8) previous clinically significant
adverse reaction to bupropion; 9) 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; 10) active participation in substance abuse treatment or
mental health treatment (including outpatient, day-treatment, residential, or inpatient)
within 28 days prior to signing consent; 11) non-English speaking (due to the difficulty
in translating the additional materials given to the subjects); 12) cognitively impaired
or of low intelligence;13) breastfeeding; 14) current use of other psychotropic
medications including nicotine replacement therapy; 15) current opiate dependence.
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| NCT ID: |
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NCT00936299 |
| Primary Contact: |
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Principal Investigator
Paula D Riggs, M.D.
University of Colorado, Denver
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| Backup Contact: |
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N/A |
| Location Contact: |
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Denver, Colorado 80210
United States
There is no listed contact information for this specific location.
Site Status: N/A |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 24, 2013 |
| Modifications to this listing: |
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