NCT00399763

Brief Summary

The purpose of this study is to find out whether atomoxetine (also called Strattera) helps teenagers (12-19) with Attention Deficit Hyperactivity Disorder (ADHD) and drug/alcohol problems.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2005

Typical duration for not_applicable

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

Study Start

First participant enrolled

September 1, 2005

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 13, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 15, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
7.4 years until next milestone

Results Posted

Study results publicly available

July 8, 2015

Completed
Last Updated

July 8, 2015

Status Verified

June 1, 2015

Enrollment Period

2.4 years

First QC Date

November 13, 2006

Results QC Date

August 3, 2012

Last Update Submit

June 12, 2015

Conditions

Attention Deficit Hyperactivity DisorderSubstance Abuse

Keywords

AdolescentADHDSUD

Outcome Measures

Primary Outcomes (1)

  • Change in Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) Attention-deficit/Hyperactivity Disorder (ADHD) Checklist

    All 18 ADHD symptoms are rated on a scale of 0 (none) to 3 (severe) since the previous study visit. The scores are summed to create a total ADHD severity scale score ranging from 0 (none) to 54 (most severe). A single value of mean change in ADHD severity for each group (placebo and atomoxetine) was calculated using linear mixed models in an intent-to-treat an analysis.

    baseline and weekly through week 12 post randomization

Secondary Outcomes (2)

  • Time Line Followback Interview (TLFB)

    12 weeks

  • Side Effect Form for Children and Adolescents (SEFCA)

    weekly from randomization to 12 weeks post-randomization

Study Arms (2)

1

PLACEBO COMPARATOR

placebo plus individual cognitive behavioral therapy

Drug: Placebo

2

EXPERIMENTAL

atomoxetine plus individual cognitive behavioral therapy

Drug: Atomoxetine

Interventions

AtomoxetineDRUG

Half of participants are randomized to atomoxetine plus individual cognitive behavioral therapy targeting substance use disorder

Also known as: Strattera
2
PlaceboDRUG

Half of participants are randomized to placebo plus individual cognitive behavioral therapy targeting substance use disorder

1

Eligibility Criteria

Age12 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age 12-19
  • Provided assent/consent
  • attention-deficit hyperactivity disorder (ADHD) by Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS)
  • Diagnostic and statistical manual of mental disorders, 4th edition (DSM-IV) checklist \<=22
  • At least one non-nicotine substance use disorder (SUD) by KSADS
  • Plans to live locally for 4 months
  • Willing to participate in cognitive behavioral therapy (CBT)

You may not qualify if:

  • No mental illness that cannot be managed as an outpatient or without concurrent psychotropic medication
  • No allergy to atomoxetine
  • No narrow angle glaucoma
  • No serious medical illness
  • Not pregnant
  • Not unwilling to use an effective form of contraception during the trial
  • No SUD that cannot be managed as an outpatient or without concurrent psychotropic medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Denver Health Medical Center

Denver, Colorado, 80204, United States

Location

Related Publications (1)

  • Thurstone C, Riggs PD, Salomonsen-Sautel S, Mikulich-Gilbertson SK. Randomized, controlled trial of atomoxetine for attention-deficit/hyperactivity disorder in adolescents with substance use disorder. J Am Acad Child Adolesc Psychiatry. 2010 Jun;49(6):573-82. doi: 10.1016/j.jaac.2010.02.013.

    PMID: 20494267DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivitySubstance-Related Disorders

Interventions

Atomoxetine Hydrochloride

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental DisordersChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic Chemicals

Limitations and Caveats

1. The study was not powered to assess safety. 2. Participants received individual motivational interviewing/cognitive behavioral therapy for substance treatment. The results may not generalize to samples receiving different behavioral treatment.

Results Point of Contact

Title
Christian Thurstone, M.D.
Organization
Denver Health
christian.thurstone@dhha.org
303-436-6006

Study Officials

  • Christian C Thurstone, MD

    Denver Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2006

First Posted

November 15, 2006

Study Start

September 1, 2005

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

July 8, 2015

Results First Posted

July 8, 2015

Record last verified: 2015-06

Locations

US(1)