Status:
COMPLETED
Atomoxetine/Attention Deficit/ Hyperactive Disorder (ADHD)/Substance Use Disorder (SUD)in a Residential Treatment Facility
Lead Sponsor:
NYU Langone Health
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Attention Deficit Hyperactivity Disorder
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
Although Attention Deficit/ Hyperactive Disorder (ADHD) is a common comorbidity in individuals diagnosed with Substance Use Disorder (SUD), little data currently exists on the utility of screening too...
Detailed Description
Phase 1: Patients with SUD who were either newly admitted (abstinent for \<1 week) or in treatment in the RTF (abstinent \<3 months) were administered the Adult ADHD Self-Report Scale Symptom Checklis...
Eligibility Criteria
Inclusion
- Are between the ages of 18-60, inclusive.
- Meet diagnostic criteria for substance dependence.
- Meet Diagnostic and Statistics Manual of Mental Disorders-IV (DSM-IV) criteria for attention deficit hyperactivity disorder as assessed by the Adult ADHD Clinician Diagnostic Scale (ACDS).
- Must be able to communicate effectively with the investigator and study staff.
- Must be able to swallow capsules.
- Reside at Odyssey House for duration of study.
Exclusion
- Lifetime or present history of bipolar disorder, schizophrenia or schizoaffective disorder. Assessment will be made by comprehensive psychiatric diagnostic interview.
- Have organic brain disease (such as dementia) or traumatic brain injury residua. Have a history of seizure disorder (other than febrile seizures) or patients who have taken (or are currently taking) anticonvulsants for seizure control.
- Females who are currently pregnant or breast feeding, and women of child-bearing potential who are not currently using an adequate form of birth control.
- Medical conditions limiting participation in the study.
- Patients who are at serious suicidal or homicidal risk.
- Have significant prior or current medical conditions that could be exacerbated or compromised by atomoxetine.
- Who have glaucoma.
- Have a history of difficulty starting a stream of urine or other symptoms suggestive of prostate enlargement.
- Who anticipate moving or traveling extensively during the study period.
- Have a medical condition that would, in the opinion of the study physician, make participation medically hazardous.
- Be anyone who in the opinion of the investigator would not be expected to complete the study protocol due to probable incarceration or relocation from the clinic area.
- \-
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00953862
Start Date
July 1 2005
End Date
April 1 2008
Last Update
March 28 2016
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