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Completed

NCT Number: NCT00218543

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

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.

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Key information

Conditions

Attention Deficit Disorder With Hyperactivity Attention Deficit and Disruptive Behavior Disorders Chemically-Induced Disorders Cocaine-Related Disorders Mental Disorders Neurodevelopmental Disorders Substance-Related Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Foundation for Mental Hygiene, Inc.

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Atomoxetine

Drug

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.

Primary outcomes

  1. the Adult ADHD Rating Scale (AARS) (30% Reduction)

    Time frame: baseline compared to rating at week 12 or last rating during study participation

    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.

  2. ADHD Symptoms Based on Adult ADHD Rating Scale Scale (AARS)

    Time frame: measured during 12 weeks or length of study participation

    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.

Sponsors and collaborators

Lead sponsor

New York State Psychiatric Institute

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Atomoxetine Treatment for Cocaine Abuse and Adult Attention-Deficit Hyperactivity Disorder (ADHD): A Preliminary Open Trial

Acronym: Atom

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Sep 22, 2005
Registry last updated
Apr 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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