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

NCT00953862 | Completed Results

• 2 other identifiers: IRB#12233BAZ-US-X031
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHD; Substance Use Disorder; Residential Treatment Facility

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline and week 10 of treatment

Secondary Outcomes (2)

• Change in Adult ADHD Symptom Rating Scale v1.1 Symptom Checklist Score

  Baseline and week 10 of treatment

• Change in Clinical Global Impression-- Severity of Illness Score

  Baseline and week 10 of treatment

Study Arms (1)

Atomoxetine Treatment Arm

EXPERIMENTAL

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.

Drug: Atomoxetine

Interventions

Atomoxetine 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.

Atomoxetine Treatment Arm

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead
• Eli Lilly and Company: collaborator

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Substance-Related Disorders

Interventions

Atomoxetine Hydrochloride

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals

Results Point of Contact

• Title: Dr. Lenard Adler
• Organization: NYU School of Medicine

lenard.adler@nyumc.org

(212) 263-3580

Study Officials

• Lenard Adler, MD

  NYU School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2009
• First Posted: August 6, 2009
• Study Start: July 1, 2005
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: March 28, 2016
• Results First Posted: March 28, 2016

Record last verified: 2016-03