Attention Deficit Hyperactivity Disorder Clinical Trial
Official title:
Efficacy of Atomoxetine in Adults With ADHD and Substance Abuse Disorder Being Treated in a Residential Treatment Facility
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 tools in large samples of adult patients with SUD in inpatient treatment. This was a 10-week, 2-phase, open label trial of atomoxetine for ADHD in adult patients being treated for a co-morbid SUD in a residential treatment facility (RFT). The primary objective of the study was to assess the efficacy of atomoxetine in adults with an SUD and ADHD. Secondary objects included assessment of the co-morbidity of ADHD and the safety and tolerability of atomoxetine in this population.
Phase @: 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 Checklist (ASRS) v. 1.1 Screener. Patients who screened positive(> 4/6
significant items) were then administered the Adult Clinician Diagnostic Scale (ACDS) v.1.2
to establish a diagnosis of ADHD and the Predictive Value Positive (PVP) in this population.
Phase II (Treatment): Participants who screened positive for ADHD on the ACDS were given
informed consent and baseline evaluations for inclusion. Those meeting inclusion/exclusion
criteria were treated with atomoxetine starting at 25 mg/day. The dose was adjusted based on
clinical response and tolerability over a 4-week period up to 120 mg/day and held constant
for the final six weeks of the trial.
;
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label
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