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Atomoxetine/Attention Deficit/ Hyperactive Disorder (ADHD)/Substance Use Disorder (SUD)in a Residential Treatment Facility

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Lenard Adler, New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00953862
First received: August 4, 2009
Last updated: March 11, 2013
Last verified: March 2013

August 4, 2009
March 11, 2013
July 2005
April 2008   (final data collection date for primary outcome measure)
ASRS v1.1 for ADHD [ Time Frame: once at screening ] [ Designated as safety issue: No ]
ASRS v1.1 for ADHD [ Time Frame: screening ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00953862 on ClinicalTrials.gov Archive Site
AISRS for ADHD [ Time Frame: baseline, weeks 2, 4, 6 and 10 ] [ Designated as safety issue: No ]
AISRS for ADHD [ Time Frame: screening, weekly ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Atomoxetine/Attention Deficit/ Hyperactive Disorder (ADHD)/Substance Use Disorder (SUD)in a Residential Treatment Facility
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.

Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Attention Deficit Hyperactivity Disorder
Drug: atomoxetine
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.
  • 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.
    Intervention: Drug: atomoxetine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
April 2008
April 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Are between the ages of 18-60, inclusive.
  2. Meet diagnostic criteria for substance dependence.
  3. Meet DSM-IV criteria for attention deficit hyperactivity disorder as assessed by the Adult ADHD Clinician Diagnostic Scale (ACDS).
  4. Must be able to communicate effectively with the investigator and study staff.
  5. Must be able to swallow capsules.
  6. Reside at Odyssey House for duration of study.

Exclusion Criteria:

  1. Lifetime or present history of bipolar disorder, schizophrenia or schizoaffective disorder. Assessment will be made by comprehensive psychiatric diagnostic interview.
  2. 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.
  3. 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.
  4. Medical conditions limiting participation in the study.
  5. Patients who are at serious suicidal or homicidal risk.
  6. Have significant prior or current medical conditions that could be exacerbated or compromised by atomoxetine.
  7. Who have glaucoma.
  8. Have a history of difficulty starting a stream of urine or other symptoms suggestive of prostate enlargement.
  9. Who anticipate moving or traveling extensively during the study period.
  10. Have a medical condition that would, in the opinion of the study physician, make participation medically hazardous.
  11. 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.

    -

Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00953862
IRB#12233, BAZ-US-X031
No
Lenard Adler, New York University School of Medicine
New York University School of Medicine
Eli Lilly and Company
Principal Investigator: Lenard Adler, MD NYU School of Medicine
New York University School of Medicine
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP