Status:
COMPLETED
Atomoxetine for Treating Marijuana-Abusing Adolescents Who Have Attention Deficit Hyperactivity Disorder
Lead Sponsor:
New York State Psychiatric Institute
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Attention Deficit Disorder With Hyperactivity
Marijuana Abuse
Eligibility:
All Genders
14-21 years
Phase:
PHASE2
Brief Summary
Attention Deficit Hyperactivity Disorder (ADHD) is common among adolescents seeking treatment for marijuana dependence. The purpose of this study is to determine the use of atomoxetine in treating ado...
Detailed Description
Attention Deficit Hyperactivity Disorder (ADHD) is common among adolescents seeking treatment for marijuana dependence. Therefore, it is important to develop treatments targeting adolescents diagnosed...
Eligibility Criteria
Inclusion
- Meets DSM-IV criteria for marijuana dependence and reports that marijuana is their primary drug of abuse
- Meets DSM-IV criteria for ADHD, as determined by the CAADID
- Females will be included if not pregnant or breastfeeding, and agree to use an adequate method of contraception for the duration of the study
Exclusion
- Meets DSM-IV criteria for schizophrenia, schizoaffective illness, psychotic disorder other than transient psychosis due to drug abuse, current major depression, bipolar illness, or psychiatric disorders (individuals with substance-induced mood disorder with depressive features as well as substance induced anxiety disorder will not be excluded from the study)
- Medically unstable (based on laboratory tests, an electrocardiogram, medical history, and physical examination) such that study participation would be hazardous; examples include uncontrolled high blood pressure and faster than normal heart rate (systolic blood pressure greater than 130, diastolic blood pressure greater than 80, or a resting heart rate greater than 90) or diabetes
- History of seizures
- Current suicidal risk
- Pregnant or breastfeeding
- Physiologically dependent on any other drugs (excluding nicotine) that requires a medical intervention
- Known sensitivity to atomoxetine
- Prior treatment failure with atomoxetine
- Currently receiving effective treatment with atomoxetine
- Coronary vascular disease, as indicated by a history or suspected by an abnormal ECG or history of cardiac symptoms
- Currently taking a psychotropic medication
- Currently taking cough medicine (e.g., dextromethorphan) or albuterol
- Currently taking or history of taking monoamine oxidase inhibitors (MAOIs) within 2 weeks prior to enrollment
- Narrow angle glaucoma
- Hepatitis
- Adolescents who are prisoners as defined by OHRP regulations, namely directly court-mandated adolescents (as opposed to probation or parole-mandated clients, as well as voluntary clients, who will not be excluded)
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2007
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00142961
Start Date
October 1 2005
End Date
January 1 2007
Last Update
April 23 2019
Active Locations (1)
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1
Phoenix House
New York, New York, United States, 10032