Status:
COMPLETED
Atomoxetine for Treating Cocaine Abuse in Adults With Attention Deficit Hyperactivity Disorder (ADHD)
Lead Sponsor:
New York State Psychiatric Institute
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Attention Deficit Disorder With Hyperactivity
Cocaine-Related Disorders
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
Studies have shown that individuals with attention deficit hyperactivity disorder (ADHD) are at greater risk for having a substance use disorder compared to people who do not have ADHD. Rates of cocai...
Detailed Description
ADHD is a neurologic disorder that is thought to be caused by chemical imbalances of certain neurotransmitters in the brain. The disorder can cause inattention, hyperactivity, and impulsivity. Cocaine...
Eligibility Criteria
Inclusion
- Meets DSM-IV criteria for cocaine dependence and adult ADHD
- Describes cocaine as the primary drug of abuse
- Meets DSM-IV criteria for cocaine dependence
Exclusion
- Meets DSM-IV criteria for current Axis I psychiatric disorders that require a psychiatric intervention (except ADHD or substance abuse)
- Current major depression
- Unstable physical disorders that might make participation unsafe (e.g., uncontrolled high blood pressure and tachycardia \[systolic blood pressure greater than 150 mm Hg, diastolic blood pressure greater than 90 mm Hg, or a sitting heart rate greater than 100\])
- Acute hepatitis (individuals with chronic mildly elevated transaminase levels of less than 2 or 3 times the normal limit are not excluded)
- Diabetes
- Coronary vascular disease, as indicated by a history or suspected by an abnormal electrocardiogram
- History of cardiac symptoms
- History of seizures
- Narrow angle glaucoma
- Use of monoamine oxidase inhibitors (MAOIs) within 2 weeks of starting treatment with atomoxetine
- Currently taking prescribed psychotropic medications
- Currently taking medications for the treatment of ADHD
- Known sensitivity to atomoxetine
- Current suicidal ideation or history of suicidal or homicidal behavior within 2 years prior to study entry
- Pregnant or breastfeeding
- Physiologically dependent on any drugs other than nicotine or marijuana
- History of schizophrenia, bipolar disorder, or other psychotic disorders
- Currently taking cough medicine (e.g., dextromethorphan) and/or albuterol
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00218543
Start Date
June 1 2004
End Date
March 1 2007
Last Update
April 24 2019
Active Locations (1)
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1
Research Foundation for Mental Hygiene, Inc.
New York, New York, United States, 10032