Atomoxetine for Treating Cocaine Abuse in Adults With Attention Deficit Hyperactivity Disorder (ADHD) (Atom)
Atomoxetine Treatment for Cocaine Abuse and Adult Attention-Deficit Hyperactivity Disorder (ADHD): A Preliminary Open Trial
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 2
Kontakty a umístění
Studijní místa
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New York
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New York, New York, Spojené státy, 10032
- Research Foundation for Mental Hygiene, Inc.
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Atomoxetine
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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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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the Adult ADHD Rating Scale (AARS) (30% Reduction)
Časové okno: baseline compared to rating at week 12 or last rating during study participation
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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.
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baseline compared to rating at week 12 or last rating during study participation
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ADHD Symptoms Based on Adult ADHD Rating Scale Scale (AARS)
Časové okno: measured during 12 weeks or length of study participation
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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.
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measured during 12 weeks or length of study participation
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Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Herbert Kleber, MD, New York State Psychiatric Institute
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Duševní poruchy
- Chemicky indukované poruchy
- Patologické procesy
- Nemoci nervového systému
- Poruchy související s látkami
- Neurologické projevy
- Dyskineze
- Deficit pozornosti a rušivé poruchy chování
- Neurologické vývojové poruchy
- Choroba
- Porucha pozornosti s hyperaktivitou
- Hyperkineze
- Poruchy související s kokainem
- Fyziologické účinky léků
- Adrenergní látky
- Neurotransmiterové látky
- Molekulární mechanismy farmakologického působení
- Inhibitory vychytávání neurotransmiterů
- Membránové transportní modulátory
- Inhibitory adrenergního vychytávání
- Atomoxetin hydrochlorid
Další identifikační čísla studie
- #4611
- DPMC (Jiný identifikátor: NIDA)
- P50DA009236 (Grant/smlouva NIH USA)
- P50-09236-12
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