Atomoxetine for Treating Marijuana-Abusing Adolescents Who Have Attention Deficit Hyperactivity Disorder

• Status: Completed
• Trial end date: 2007-01-01
• Target enrollment: 0
• Participant gender: All

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 adolescents who abuse marijuana and have ADHD. In addition, this study will assess whether atomoxetine reduces ADHD symptoms as compared to a placebo. Finally, the study will determine whether atomoxetine improves treatment retention and progress in adolescents with ADHD and marijuana dependence.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York State Psychiatric Institute
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Atomoxetine Hydrochloride

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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)