CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 105 enrolled
Drug / intervention
Bupropion +1 moredrug
Likely dose
Bupropion 300 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00936299
NCT00936299Phase 4Completed

Bupropion for ADHD in Adolescents With Substance Use Disorder

University of Colorado, Denver·interventional·Posted Jul 10, 2009·Updated Dec 23, 2019

In Brief

A Phase 4 clinical trial evaluating Bupropion and Placebo for Attention Deficit Hyperactivity Disorder and 2 related conditions. Completed, enrolled 105 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 10, 2009
Enrollment StartJan 1, 2009
Primary CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 17.0 years ago

Interventions

Bupropiondrug

Bupropion (target dose 300 mg/day) + cognitive behavioral therapy; matched placebo + cognitive behavioral therapy

Placeboother