|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsor: | National Institute on Drug Abuse (NIDA) |
|---|---|
| Information provided by: | National Institute on Drug Abuse (NIDA) |
| ClinicalTrials.gov Identifier: | NCT00936299 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Attention Deficit Hyperactivity Disorder Nicotine Dependence Cannabis Use Disorder |
Drug: Bupropion, Cognitive Behavioral Therapy |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Bupropion for ADHD in Adolescents With Substance Use Disorder |
| Estimated Enrollment: | 130 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
bupropion + cognitive behavioral therapy: Placebo Comparator
Adolescents with ADHD, nicotine dependence, and cannabis use disorders receive placebo + CBT.
|
Drug: Bupropion, Cognitive Behavioral Therapy
Target dose 300 mg/day Cognitive Behavioral Therapy
|
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.
Eligibility| Ages Eligible for Study: | 13 Years to 19 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
-
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
Contacts and Locations| Contact: Michelle A Lohman, BS, RN | 303 935-5892 | michelle.lohman@ucdenver.edu |
| Contact: Ashley B Myracle, MS | 303 935-5892 | ashley.myracle@ucdenver.edu |
| United States, Colorado | |
| University of Colorado Denver, Adolescent Clinical Research | Recruiting |
| Denver, Colorado, United States, 80210 | |
| Contact: Michelle A Lohman, BS, RN 303-935-5892 michelle.lohman@ucdenver.edu | |
| Contact: Ashley B Myracle, MA 303 935-5892 ashley.myracle@ucdenver.edu | |
| Principal Investigator: Paula D Riggs, MD | |
| Sub-Investigator: Robert Davies, MD | |
| Principal Investigator: | Paula D Riggs, M.D. | University of Colorado, Denver |
More Information
| Responsible Party: | University of Colorado Denver ( Paula Riggs, M.D. ) |
| Study ID Numbers: | DA022284, R01 DA022284 |
| Study First Received: | July 8, 2009 |
| Last Updated: | July 8, 2009 |
| ClinicalTrials.gov Identifier: | NCT00936299 History of Changes |
| Health Authority: | United States: Federal Government |
|
Adolescents Substance Use Disorder Attention Deficit Hyperactivity Disorder Cognitive Behavioral Therapy |
|
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Disorders of Environmental Origin Signs and Symptoms Pathologic Processes Attention Deficit Disorder with Hyperactivity Mental Disorders Therapeutic Uses Mental Disorders Diagnosed in Childhood Substance-Related Disorders |
Hyperkinesis Antidepressive Agents, Second-Generation Antidepressive Agents Disease Tobacco Use Disorder Nervous System Diseases Attention Deficit and Disruptive Behavior Disorders Dyskinesias Pharmacologic Actions Bupropion Neurologic Manifestations Dopamine Agents Central Nervous System Agents |
