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| ID | Type | Description | Link |
|---|---|---|---|
| P50DA009236 | U.S. NIH Grant/Contract | View source | |
| P50-09236-12 | |||
| DPMC |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atomoxetine | Experimental | Atomoxetine |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| the Adult ADHD Rating Scale (AARS) (30% Reduction) | 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. | baseline compared to rating at week 12 or last rating during study participation |
| ADHD Symptoms Based on Adult ADHD Rating Scale Scale (AARS) | 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. | measured during 12 weeks or length of study participation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Herbert Kleber, MD | New York State Psychiatric Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Foundation for Mental Hygiene, Inc. | New York | New York | 10032 | United States |
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| Label | URL |
|---|---|
| Click here for the Substance Treatment and Research Service website | View source |
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Participants were seeking treatment for problems related to cocaine use and were recruited by local advertising/referrals in the New York City area. Two types of adS were placed: (1) ads for treatment of cocaine dependence, and (2) ads for treatment for cocaine dependence and possible problems with inattention and/or hyperactivity.
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| ID | Title | Description |
|---|---|---|
| FG000 | Atomoxetine | Initially, atomoxetine was administered at 20 mg/day for three days. This dose was then increased to 40 mg/day for four days. During the second week of the trial, the dose was increased to 60 mg/day and later increased to 80 mg/day at the start of Week 3. Patients were then maintained at 80 mg per day for four weeks. At the beginning of Week 7, patients were maintained at 80 mg/day or increased to the maximal dose of 100 mg/day if there was less than a 50% reduction of ADHD symptoms (as determined by the Adult ADHD Rating Scale; Murphy, 1996) and if the patients were tolerating the medication well. They were then maintained at 80 mg/day or 100 mg/day for the remaining six weeks of the trial. All patients received two capsules to be taken once a day in the morning. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Atomoxetine | Initially, atomoxetine was administered at 20 mg/day for three days. This dose was then increased to 40 mg/day for four days. During the second week of the trial, the dose was increased to 60 mg/day and later increased to 80 mg/day at the start of Week 3. Patients were then maintained at 80 mg per day for four weeks. At the beginning of Week 7, patients were maintained at 80 mg/day or increased to the maximal dose of 100 mg/day if there was less than a 50% reduction of ADHD symptoms (as determined by the Adult ADHD Rating Scale; Murphy, 1996) and if the patients were tolerating the medication well. They were then maintained at 80 mg/day or 100 mg/day for the remaining six weeks of the trial. All patients received two capsules to be taken once a day in the morning. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | the Adult ADHD Rating Scale (AARS) (30% Reduction) | 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. | All participants | Posted | Number | percent of participants | baseline compared to rating at week 12 or last rating during study participation |
|
12 weeks or length of study participation
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Atomoxetine | Initially, atomoxetine was administered at 20 mg/day for three days. This dose was then increased to 40 mg/day for four days. During the second week of the trial, the dose was increased to 60 mg/day and later increased to 80 mg/day at the start of Week 3. Patients were then maintained at 80 mg per day for four weeks. At the beginning of Week 7, patients were maintained at 80 mg/day or increased to the maximal dose of 100 mg/day if there was less than a 50% reduction of ADHD symptoms (as determined by the Adult ADHD Rating Scale; Murphy, 1996) and if the patients were tolerating the medication well. They were then maintained at 80 mg/day or 100 mg/day for the remaining six weeks of the trial. All patients received two capsules to be taken once a day in the morning. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nausea | Gastrointestinal disorders | Systematic Assessment |
Clearly, there are limitations of this study including the high drop-out rate, small sample size, and lack of a control group.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Frances R Levin, MD | COLUMBIA UNIVERSITY | 212-543-5896 | FRL2@COLUMBIA.EDU |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| D019970 | Cocaine-Related Disorders |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D019966 | Substance-Related Disorders |
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| ID | Term |
|---|---|
| D000069445 | Atomoxetine Hydrochloride |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Physician Decision |
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| Adverse Event |
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | ADHD Symptoms Based on Adult ADHD Rating Scale Scale (AARS) | 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. | Comparing overall baseline scores to end of study scores for patients who had at least two AARS weekly measures completed | Posted | Mean | Standard Deviation | scores on a scale | measured during 12 weeks or length of study participation |
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| 0 |
| 20 |
| 5 |
| 20 |
| headache | General disorders | Systematic Assessment |
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| chest pain | Cardiac disorders | Systematic Assessment |
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| anxiety | Psychiatric disorders | Systematic Assessment |
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| dizziness | General disorders | Systematic Assessment |
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| D064419 | Chemically-Induced Disorders |