Clinical trial NCT00218543: Atomoxetine for Treating Cocaine Abuse in Adults With Attention Deficit Hyperactivity Disorder (ADHD)
Official title: Atomoxetine Treatment for Cocaine Abuse and Adult Attention-Deficit Hyperactivity Disorder (ADHD): A Preliminary Open Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Attention Deficit Disorder With Hyperactivity
Cocaine-Related Disorders
Keywords: ADHD
Cocaine Abuse
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2005-09-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: the Adult ADHD Rating Scale (AARS) (30% Reduction)
timeFrame: baseline compared to rating at week 12 or last rating during study participation
measure: ADHD Symptoms Based on Adult ADHD Rating Scale Scale (AARS)
timeFrame: measured during 12 weeks or length of study participation
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Research Foundation for Mental Hygiene, Inc.
state: New York
Study officials:
affiliation: New York State Psychiatric Institute
name: Herbert Kleber, MD
role: PRINCIPAL_INVESTIGATOR
References: