Atomoxetine for Treating Cocaine Abuse in Adults With Attention Deficit Hyperactivity Disorder (ADHD)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00218543
First received: September 20, 2005
Last updated: June 25, 2012
Last verified: June 2012
  Purpose

Studies have shown that individuals with attention deficit hyperactivity disorder (ADHD) are at greater risk for having a substance use disorder compared to people who do not have ADHD. Rates of cocaine abuse in adults with ADHD are significantly higher than they are in adults who do not have ADHD. Some clinicians suggest that adults with ADHD may abuse cocaine in order to self-medicate their ADHD symptoms. Atomoxetine is a drug that has been effective in treating ADHD. This study will evaluate the effectiveness of atomoxetine in reducing cocaine use in people with ADHD who abuse cocaine.


Condition Intervention Phase
Attention Deficit Disorder With Hyperactivity
Cocaine-Related Disorders
Drug: Atomoxetine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Atomoxetine Treatment for Cocaine Abuse and Adult Attention-Deficit Hyperactivity Disorder (ADHD): A Preliminary Open Trial

Resource links provided by NLM:


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

Primary Outcome Measures:
  • the Adult ADHD Rating Scale (AARS) (30% Reduction) [ Time Frame: baseline compared to rating at week 12 or last rating during study participation ] [ Designated as safety issue: No ]
    AARS is a self report that measures symptoms of adult ADHD. The primary outcome was the percentage of patients achieving a 30% reduction from baseline on the AARS scale. The AARS is scored on a continuous, range 0-54. 0 being no symptoms and 54 being indicative of the most severe level of symptoms.

  • ADHD Symptoms Based on Adult ADHD Rating Scale Scale (AARS) [ Time Frame: measured during 12 weeks or length of study participation ] [ Designated as safety issue: No ]
    Weekly AARS scores (continuous, range 0-54) were examined with the baseline score compared to that at the last assessment obtained and change in these scores over time. The AARS looks at adult ADHD symptoms. A score of 0 represents no symptoms and 54 would be indicative of the most severe level of symptoms.


Enrollment: 20
Study Start Date: June 2004
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Atomoxetine
Atomoxetine
Drug: Atomoxetine
At the start of week 7, patients will be maintained at 80 mg/day or increased to the maximal dose of 100 mg/day if less than a 50% reduction of symptoms on the ADHD Rating Scale occurs, and if the patient is tolerating the medication well.

Detailed Description:

ADHD is a neurologic disorder that is thought to be caused by chemical imbalances of certain neurotransmitters in the brain. The disorder can cause inattention, hyperactivity, and impulsivity. Cocaine abuse rates in adults with ADHD are significantly higher than they are in adults who do not have the disorder. This may be reflective of an attempt by individuals with ADHD to self-treat symptoms. Atomoxetine is an FDA-approved drug that is used to increase the ability to pay attention and decrease impulsiveness and hyperactivity in children and adults with ADHD. The drug is in a class of medications called selective norepinephrine reuptake inhibitors and works by increasing the levels of norepinephrine, a natural substance in the brain that affects a person's attention and impulsivity. It is possible that reducing ADHD symptoms in cocaine abusers with ADHD will help decrease their need for cocaine. This study will evaluate the effectiveness of atomoxetine in reducing cocaine use in people with ADHD who abuse cocaine.

Participants in this open label study will receive atomoxetine for 12 weeks, and will take one dose each morning for the duration of the study. Doses will be increased gradually to minimize side effects and enhance treatment compliance. In addition, all participants will receive individualized relapse prevention therapy once weekly. Participants will be required to report to the study site three times a week to receive medication, complete questionnaires regarding ADHD symptoms and substance use behavior, and provide a urine sample while being supervised by study staff. Also, vital signs will be monitored and medication side effects will be assessed at each visit. Participants will report to the study site 6 months after starting in the study for a follow-up visit, at which time ADHD symptoms, substance use behavior, and social functioning will be assessed.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Meets DSM-IV criteria for cocaine dependence and adult ADHD
  • Describes cocaine as the primary drug of abuse
  • Meets DSM-IV criteria for cocaine dependence

Exclusion Criteria:

  • Meets DSM-IV criteria for current Axis I psychiatric disorders that require a psychiatric intervention (except ADHD or substance abuse)
  • Current major depression
  • Unstable physical disorders that might make participation unsafe (e.g., uncontrolled high blood pressure and tachycardia [systolic blood pressure greater than 150 mm Hg, diastolic blood pressure greater than 90 mm Hg, or a sitting heart rate greater than 100])
  • Acute hepatitis (individuals with chronic mildly elevated transaminase levels of less than 2 or 3 times the normal limit are not excluded)
  • Diabetes
  • Coronary vascular disease, as indicated by a history or suspected by an abnormal electrocardiogram
  • History of cardiac symptoms
  • History of seizures
  • Narrow angle glaucoma
  • Use of monoamine oxidase inhibitors (MAOIs) within 2 weeks of starting treatment with atomoxetine
  • Currently taking prescribed psychotropic medications
  • Currently taking medications for the treatment of ADHD
  • Known sensitivity to atomoxetine
  • Current suicidal ideation or history of suicidal or homicidal behavior within 2 years prior to study entry
  • Pregnant or breastfeeding
  • Physiologically dependent on any drugs other than nicotine or marijuana
  • History of schizophrenia, bipolar disorder, or other psychotic disorders
  • Currently taking cough medicine (e.g., dextromethorphan) and/or albuterol
  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: NCT00218543

Locations
United States, New York
Research Foundation for Mental Hygiene, Inc.
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
Principal Investigator: Herbert Kleber, MD New York State Psychiatric Institute
  More Information

No publications provided

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00218543     History of Changes
Other Study ID Numbers: #4611, P50DA009236, P50-09236-12, DPMC
Study First Received: September 20, 2005
Results First Received: January 12, 2012
Last Updated: June 25, 2012
Health Authority: United States: Federal Government

Keywords provided by New York State Psychiatric Institute:
ADHD
Cocaine Abuse

Additional relevant MeSH terms:
Cocaine-Related Disorders
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Cocaine
Atomoxetine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Vasoconstrictor Agents
Cardiovascular Agents
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on August 28, 2014