NCT00142961

Brief Summary

Attention Deficit Hyperactivity Disorder (ADHD) is common among adolescents seeking treatment for marijuana dependence. The purpose of this study is to determine the use of atomoxetine in treating adolescents who abuse marijuana and have ADHD. In addition, this study will assess whether atomoxetine reduces ADHD symptoms as compared to a placebo. Finally, the study will determine whether atomoxetine improves treatment retention and progress in adolescents with ADHD and marijuana dependence.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2005

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

September 1, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2005

Completed
29 days until next milestone

Study Start

First participant enrolled

October 1, 2005

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

April 23, 2019

Status Verified

April 1, 2019

Enrollment Period

1.3 years

First QC Date

September 1, 2005

Last Update Submit

April 22, 2019

Conditions

Attention Deficit Disorder With HyperactivityMarijuana Abuse

Keywords

cannabis abuseatomoxetineADHD

Outcome Measures

Primary Outcomes (1)

  • ADHD response and reduction in ADHD symptoms; measured at Week 12

    12 weeks of trial or length of participation

Study Arms (2)

1

EXPERIMENTAL

Atomoxetine prescribed daily

Drug: Atomoxetine

2

PLACEBO COMPARATOR

placebo controlled arm

Other: placebo

Interventions

AtomoxetineDRUG

atomoxetine

1
placeboOTHER
2

Eligibility Criteria

Age14 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Meets DSM-IV criteria for marijuana dependence and reports that marijuana is their primary drug of abuse
  • Meets DSM-IV criteria for ADHD, as determined by the CAADID
  • Females will be included if not pregnant or breastfeeding, and agree to use an adequate method of contraception for the duration of the study

You may not qualify if:

  • Meets DSM-IV criteria for schizophrenia, schizoaffective illness, psychotic disorder other than transient psychosis due to drug abuse, current major depression, bipolar illness, or psychiatric disorders (individuals with substance-induced mood disorder with depressive features as well as substance induced anxiety disorder will not be excluded from the study)
  • Medically unstable (based on laboratory tests, an electrocardiogram, medical history, and physical examination) such that study participation would be hazardous; examples include uncontrolled high blood pressure and faster than normal heart rate (systolic blood pressure greater than 130, diastolic blood pressure greater than 80, or a resting heart rate greater than 90) or diabetes
  • History of seizures
  • Current suicidal risk
  • Pregnant or breastfeeding
  • Physiologically dependent on any other drugs (excluding nicotine) that requires a medical intervention
  • Known sensitivity to atomoxetine
  • Prior treatment failure with atomoxetine
  • Currently receiving effective treatment with atomoxetine
  • Coronary vascular disease, as indicated by a history or suspected by an abnormal ECG or history of cardiac symptoms
  • Currently taking a psychotropic medication
  • Currently taking cough medicine (e.g., dextromethorphan) or albuterol
  • Currently taking or history of taking monoamine oxidase inhibitors (MAOIs) within 2 weeks prior to enrollment
  • Narrow angle glaucoma
  • Hepatitis
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Phoenix House

New York, New York, 10032, United States

Location

Related Links

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivityMarijuana Abuse

Interventions

Atomoxetine Hydrochloride

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental DisordersSubstance-Related DisordersChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic Chemicals

Study Officials

  • Frances R Levin, M.D.

    New York State Psychiatric Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Substance Use Disorder

Study Record Dates

First Submitted

September 1, 2005

First Posted

September 2, 2005

Study Start

October 1, 2005

Primary Completion

January 1, 2007

Study Completion

January 1, 2007

Last Updated

April 23, 2019

Record last verified: 2019-04

Locations

US(1)