Clinical trial NCT00953862: 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
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: ADHD
Substance Use Disorder
Residential Treatment Facility
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
First posted: 2009-08-06
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Are between the ages of 18-60, inclusive.
2. Meet diagnostic criteria for substance dependence.
3. 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).
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.

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Primary outcomes:
measure: Change in Adult ADHD Investigator Symptom Rating Scale Score
timeFrame: Baseline and week 10 of treatment
Secondary outcomes:
measure: Change in Adult ADHD Symptom Rating Scale v1.1 Symptom Checklist Score
timeFrame: Baseline and week 10 of treatment
measure: Change in Clinical Global Impression-- Severity of Illness Score
timeFrame: Baseline and week 10 of treatment
Other outcomes:
Locations:
Study officials:
affiliation: NYU School of Medicine
name: Lenard Adler, MD
role: PRINCIPAL_INVESTIGATOR
References: