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Atomoxetine for Treating Marijuana-Abusing Adolescents Who Have Attention Deficit Hyperactivity Disorder

Primary Purpose

Attention Deficit Disorder With Hyperactivity, Marijuana Abuse

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Atomoxetine
placebo
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Disorder With Hyperactivity focused on measuring cannabis abuse, atomoxetine, ADHD

Eligibility Criteria

14 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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 Adolescents who are prisoners as defined by OHRP regulations, namely directly court-mandated adolescents (as opposed to probation or parole-mandated clients, as well as voluntary clients, who will not be excluded)

Sites / Locations

  • Phoenix House

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Atomoxetine prescribed daily

placebo controlled arm

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 1, 2005
Last Updated
April 22, 2019
Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00142961
Brief Title
Atomoxetine for Treating Marijuana-Abusing Adolescents Who Have Attention Deficit Hyperactivity Disorder
Official Title
Marijuana-Abusing Attention Deficit Hyperactivity Disorder (ADHD) Teens: Atomoxetine Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Attention Deficit Hyperactivity Disorder (ADHD) is common among adolescents seeking treatment for marijuana dependence. Therefore, it is important to develop treatments targeting adolescents diagnosed with both ADHD and marijuana dependence. Atomoxetine is currently used to treat individuals diagnosed with ADHD. The purpose of this study is to determine the feasibility of administering atomoxetine in a therapeutic setting to adolescents who abuse marijuana and have ADHD. In addition, this study will assess whether atomoxetine reduces ADHD symptoms. Finally, this study will determine whether atomoxetine improves treatment retention and progress in adolescents with ADHD and marijuana dependence. Participants in this double-blind study will be randomly assigned to receive either atomoxetine or placebo. Study visits will occur 2 times each week for the duration of the 12-week trial. At each study visit, vital signs and medication side effects will be assessed. In addition, psychiatric ratings measurements will be evaluated. Participants will also complete self reports in order to track ADHD-related symptoms. Starting at the Week 2 study visit, all participants will receive psychotherapy sessions. This will involve cognitive-behavioral therapy/relapse prevention treatment that has been designed specifically for ADHD adolescents. The aim of the cognitive skills training will be to assist the participants in developing the skills necessary to manage their drug use as well as the symptoms they experience related to ADHD. At Month 6, a follow-up visit will occur, at which time participants urine toxicology tests will be completed to determine if participants have been using marijuana or any other substances of abuse. In addition, at the Month 6 follow-up visit, participants will complete psychiatric ratings, self reports, and will meet with a physician to assess ADHD-related symptoms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Disorder With Hyperactivity, Marijuana Abuse
Keywords
cannabis abuse, atomoxetine, ADHD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Atomoxetine prescribed daily
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
placebo controlled arm
Intervention Type
Drug
Intervention Name(s)
Atomoxetine
Intervention Description
atomoxetine
Intervention Type
Other
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
ADHD response and reduction in ADHD symptoms; measured at Week 12
Time Frame
12 weeks of trial or length of participation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 Adolescents who are prisoners as defined by OHRP regulations, namely directly court-mandated adolescents (as opposed to probation or parole-mandated clients, as well as voluntary clients, who will not be excluded)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frances R Levin, M.D.
Organizational Affiliation
New York State Psychiatric Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Phoenix House
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.stars.columbia.edu
Description
Substance Treatment and Research Service

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Atomoxetine for Treating Marijuana-Abusing Adolescents Who Have Attention Deficit Hyperactivity Disorder

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