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NCT00936299 · ClinicalTrials.gov registry record · Phase 4
Bupropion for ADHD in Adolescents With Substance Use Disorder
A Phase 4 study of Attention Deficit Hyperactivity Disorder and Nicotine Dependence, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- Phase 4
- Development phase
- 105
- Enrollment target
- 1
- Study location
NCT00936299: Completed Phase 4 study of Attention Deficit Hyperactivity Disorder and Nicotine Dependence, sponsored by University of Colorado, Denver.
NCT00936299 is a Phase 4 study of Attention Deficit Hyperactivity Disorder and Nicotine Dependence that has completed, run by University of Colorado, Denver. The registered enrollment target is 105 participants, below the 216-participant average among 102 other Attention Deficit Hyperactivity Disorder trials with a reported enrollment target (51% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00936299, a Phase 4 study of Attention Deficit Hyperactivity Disorder and Nicotine Dependence, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 105 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
DSM-IV ADHD Rating Scale (ADHD-RS) Total Score (clinician administered/adolescent informant). Total scale range 0-54, higher is greater severity.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Bupropion
Study Locations (1)
Colorado
- University of Colorado Denver, Adolescent Clinical Research - Denver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2009-01 |
| Est. Completion | 2013-05 |
| Phase | Phase 4 |
What the finished NCT00936299 record still lists
NCT00936299 is an interventional study that assigns participants to a tested intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap, below the 216-participant average among 102 other Attention Deficit Hyperactivity Disorder trials with a reported enrollment target (51% lower).
The record links to 3 conditions, with Attention Deficit Hyperactivity Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00936299 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT00936299 about?
NCT00936299 is a clinical study titled "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 exc...
What is the current status of trial NCT00936299?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 105 participants. The study started on 2009-01. Estimated completion is 2013-05.
What conditions does trial NCT00936299 study?
This clinical trial studies the following conditions: Attention Deficit Hyperactivity Disorder, Nicotine Dependence, Cannabis Use Disorder.
What interventions are being tested in trial NCT00936299?
The interventions under investigation include: Placebo (OTHER), Bupropion (DRUG).
Who is sponsoring clinical trial NCT00936299?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00936299 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00936299's enrollment target sits among peer trials
105 45th of 102 higher than 58 of 102 other Attention Deficit Hyperactivity Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Attention Deficit Hyperactivity Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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