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

NCT ID: NCT00953862

Last Updated: 2016-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-07-31
• Study Completion Date: 2008-04-30

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.

Conditions

Attention Deficit Hyperactivity Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Atomoxetine

Intervention Type: DRUG

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.

Interventions

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 at the optimized level for the final 6 weeks of the trial.

Intervention Type: DRUG

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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• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lenard Adler, MD

Role: PRINCIPAL_INVESTIGATOR

NYU School of Medicine

Other Identifiers

BAZ-US-X031

Identifier Type: -

Identifier Source: secondary_id

IRB#12233

Identifier Type: -

Identifier Source: org_study_id