Atomoxetine/Attention Deficit/ Hyperactive Disorder (ADHD)/Substance Use Disorder (SUD)in a Residential Treatment Facility
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|ClinicalTrials.gov Identifier: NCT00953862|
Recruitment Status : Completed
First Posted : August 6, 2009
Results First Posted : March 28, 2016
Last Update Posted : March 28, 2016
|Condition or disease||Intervention/treatment||Phase|
|Attention Deficit Hyperactivity Disorder||Drug: Atomoxetine||Not Applicable|
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 Checklist (ASRS) v. 1.1 Screener. Patients who screened positive(>= 4 out 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy of Atomoxetine in Adults With ADHD and Substance Abuse Disorder Being Treated in a Residential Treatment Facility|
|Study Start Date :||July 2005|
|Actual Primary Completion Date :||April 2008|
|Actual Study Completion Date :||April 2008|
Experimental: Atomoxetine Treatment Arm
Patients who were identified as having adult ADHD on the ACDS were offered an open label treatment trial with atomoxetine, up to 120 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 at the optimized level for the final 6 weeks of the trial.
- Change in Adult ADHD Investigator Symptom Rating Scale Score [ Time Frame: Baseline and week 10 of treatment ]The AISRS (Adult ADHD Investigator Symptom Rating Scale) consists 18-items that directly correspond to the 18 DSM-IV symptoms of ADHD. Each item is scored on a 4-point scale (0 = none; 1 = mild; 2 = moderate; and 3 = severe, higher score is more impaired). The total summed score was at minimum 0 and at maximum 54 (the higher the score the more severe the symptomatology).
- Change in Adult ADHD Symptom Rating Scale v1.1 Symptom Checklist Score [ Time Frame: Baseline and week 10 of treatment ]The ASRS (Adult ADHD Symptom Rating Scale) v1.1 Symptom Checklist is an 18-item scale developed by the workgroup on Adult ADHD for the World Health Organization designed to assess the frequency of ADHD symptoms on a 0-4 scale (0 = never, 1 = rarely, 2 = sometimes, 3= often, and 4 = very often, minimum total summed score of 0 and maximum total summed score of 72, higher score is more impairment).
- Change in Clinical Global Impression-- Severity of Illness Score [ Time Frame: Baseline and week 10 of treatment ]The CGI-S (Clinical Global Impression-- Severity of Illness) scale is a single-item rating scale of the clinician's assessment of the global severity of ADHD symptoms in relation to the clinician's total experience with ADHD patients. Severity is rated on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00953862
|Principal Investigator:||Lenard Adler, MD||NYU School of Medicine|