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

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

Efficacy of Atomoxetine in Adults With ADHD and Substance Abuse Disorder Being Treated in a Residential Treatment Facility

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00953862
• Other study ID #: IRB#12233
• Secondary ID: BAZ-US-X031
• Status: Completed
• Phase: N/A
• First received: August 4, 2009
• Last updated: March 11, 2013
• Start date: July 2005
• Est. completion date: April 2008

Study information

• Verified date: March 2013
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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 (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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Disease

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
New York University School of Medicine	Eli Lilly and Company

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ASRS v1.1 for ADHD		once at screening	No
Secondary	AISRS for ADHD		baseline, weeks 2, 4, 6 and 10	No