NCT00029614

Brief Summary

The purpose of this study is to compare the effectiveness and safety of atomoxetine in the treatment of adolescents with coexisting alcohol or substance use disorders and Attention Deficit Hyperactivity Disorder (ADHD).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 17, 2002

Completed
4.3 years until next milestone

Study Start

First participant enrolled

May 1, 2006

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

April 28, 2010

Status Verified

April 1, 2010

First QC Date

January 16, 2002

Last Update Submit

April 27, 2010

Conditions

Substance Use DisordersAttention Deficit Hyperactivity Disorder

Keywords

ADHDSubstance Use

Outcome Measures

Primary Outcomes (2)

  • decrease in ADHD symptoms

  • decrease in the quantity and frequency of alcohol and other substance use

Interventions

AtomoxetineDRUG

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Adolescents, ages 13-18
  • Meets criteria for alcohol and/or substance use disorder and attention deficit hyperactivity disorder.

You may not qualify if:

  • Adolescents who are pregnant.
  • Have a history of seizure disorder, other neurological or medical disorder for which medication treatment may present a considerable risk.
  • History of pervasive development disorder, schizophrenia or other psychotic disorders, organic mental disorders or eating disorders.
  • Currently on other psychotropic medications from which discontinuation would present a significant risk.
  • A current episode of major depressive disorder or a diagnosis of bipolar disorder.
  • Diagnosis of dependence for any substance other than marijuana.
  • Adolescents with a full-scale IQ below 80.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western Psychiatric Institute and Clinic

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Substance-Related DisordersAttention Deficit Disorder with Hyperactivity

Interventions

Atomoxetine Hydrochloride

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersAttention Deficit and Disruptive Behavior DisordersNeurodevelopmental Disorders

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic Chemicals

Study Officials

  • Oscar G. Bukstein, MD

    Western Psychiatric Institute and Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 16, 2002

First Posted

January 17, 2002

Study Start

May 1, 2006

Study Completion

July 1, 2007

Last Updated

April 28, 2010

Record last verified: 2010-04

Locations

US(1)