Atomoxetine/Attention Deficit/ Hyperactive Disorder (ADHD)/Substance Use Disorder (SUD)in a Residential Treatment Facility
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Efficacy of Atomoxetine in Adults With ADHD and Substance Abuse Disorder Being Treated in a Residential Treatment Facility|
- ASRS v1.1 for ADHD [ Time Frame: once at screening ] [ Designated as safety issue: No ]
- AISRS for ADHD [ Time Frame: baseline, weeks 2, 4, 6 and 10 ] [ Designated as safety issue: No ]
|Study Start Date:||July 2005|
|Study Completion Date:||April 2008|
|Primary Completion Date:||April 2008 (Final data collection date for primary outcome measure)|
No Intervention: Arm I: ASRS v1.1 screener
1064 residential treatment facility patients were screened via the self-report ASRS v.1.1 Screener. Those with 4 or more significant items present were assessed for ADHD by the clinician-administered ACDS
Experimental: Arm II: Treatment Phase
Patients who were identified as having adult ADHD on the ACDS were offered an open label treatment trial with atomoxetine, up to 100 mg/day over 10 weeks. Atomoxetine was titrated over a period of four weeks based upon clinical response and observed side effects. All patients receiving atomoxetine gave written informed consent prior to participation and were assessed for ADHD symptoms via the Adult Investigator Adult ADHD Symptom Rating Scale (AISRS) every 1-2 weeks. All patients received a physical exam, review of systems and routine blood work prior to treatment. Data were analyzed for patients completing at least 2 weeks of atomoxetine therapy. Treatment response was pre-hoc defined as having a >=30% reduction in total AISRS scores from baseline.
In Phase II, atomoxetine was dispensed beginning at 25 mg/day. Dose was adjusted based on clinical response and tolerability over a 4-week period up to 120mg/day and held constant for the final 6 weeks of the trial.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00953862
|Principal Investigator:||Lenard Adler, MD||NYU School of Medicine|