Back to resultsAtomoxetine/Attention Deficit/ Hyperactive Disorder (ADHD)/Substance Use Disorder (SUD)in a Residential Treatment Facility
Primary Purpose
Attention Deficit Hyperactivity Disorder
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Atomoxetine
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring ADHD, Substance Use Disorder, Residential Treatment Facility
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
-
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Atomoxetine Treatment Arm
Arm Description
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.
Outcomes
Primary Outcome Measures
Change in Adult ADHD Investigator Symptom Rating Scale Score
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).
Secondary Outcome Measures
Change in Adult ADHD Symptom Rating Scale v1.1 Symptom Checklist Score
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
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).
Full Information
NCT ID
NCT00953862
First Posted
August 4, 2009
Last Updated
March 7, 2016
Sponsor
NYU Langone Health
Collaborators
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT00953862
Brief Title
Atomoxetine/Attention Deficit/ Hyperactive Disorder (ADHD)/Substance Use Disorder (SUD)in a Residential Treatment Facility
Official Title
Efficacy of Atomoxetine in Adults With ADHD and Substance Abuse Disorder Being Treated in a Residential Treatment Facility
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
Eli Lilly and Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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 (RTF). 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.
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
ADHD, Substance Use Disorder, Residential Treatment Facility
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Atomoxetine Treatment Arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Atomoxetine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Adult ADHD Investigator Symptom Rating Scale Score
Description
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).
Time Frame
Baseline and week 10 of treatment
Secondary Outcome Measure Information:
Title
Change in Adult ADHD Symptom Rating Scale v1.1 Symptom Checklist Score
Description
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).
Time Frame
Baseline and week 10 of treatment
Title
Change in Clinical Global Impression-- Severity of Illness Score
Description
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).
Time Frame
Baseline and week 10 of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lenard Adler, MD
Organizational Affiliation
NYU School of Medicine
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Atomoxetine/Attention Deficit/ Hyperactive Disorder (ADHD)/Substance Use Disorder (SUD)in a Residential Treatment Facility
We'll reach out to this number within 24 hrs