Effectiveness of Atomoxetine for Treating Marijuana-Abusing Adolescents Who Have Attention Deficit Hyperactivity Disorder (ADHD) - 1

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00142961
First received: September 1, 2005
Last updated: June 28, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Attention Deficit Disorder With Hyperactivity
Marijuana Abuse
Drug: Atomoxetine
Other: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Marijuana-Abusing Attention Deficit Hyperactivity Disorder (ADHD) Teens: Atomoxetine Treatment

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • ADHD response and reduction in ADHD symptoms; measured at Week 12 and Month 6

Enrollment: 2
Study Start Date: October 2005
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Atomoxetine
Drug: Atomoxetine
atomoxetine
Placebo Comparator: 2
placebo
Other: placebo

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.

  Eligibility

Ages Eligible for Study:   14 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00142961

Locations
United States, New York
Phoenix House
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
Principal Investigator: Frances R Levin, M.D. New York State Psychiatric Institute
  More Information

No publications provided

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00142961     History of Changes
Other Study ID Numbers: #4988-NIDA-19233-1, R01DA019233, R01-DA019233-1, DPMCDA
Study First Received: September 1, 2005
Last Updated: June 28, 2012
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Disease
Hyperkinesis
Marijuana Abuse
Attention Deficit and Disruptive Behavior Disorders
Chemically-Induced Disorders
Dyskinesias
Mental Disorders
Mental Disorders Diagnosed in Childhood
Nervous System Diseases
Neurologic Manifestations
Pathologic Processes
Signs and Symptoms
Substance-Related Disorders
Atomoxetine
Adrenergic Agents
Adrenergic Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 20, 2014