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
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
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New York
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New York, New York, Estados Unidos, 10032
- Research Foundation for Mental Hygiene, Inc.
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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the Adult ADHD Rating Scale (AARS) (30% Reduction)
Prazo: 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)
Prazo: 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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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Herbert Kleber, MD, New York State Psychiatric Institute
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Transtornos Mentais, Desordem Mental
- Distúrbios induzidos quimicamente
- Processos Patológicos
- Doenças do Sistema Nervoso
- Transtornos Relacionados a Substâncias
- Manifestações Neurológicas
- Discinesias
- Transtornos de Déficit de Atenção e Comportamento Disruptivo
- Distúrbios do Neurodesenvolvimento
- Doença
- Transtorno de Déficit de Atenção com Hiperatividade
- Hipercinesia
- Transtornos Relacionados à Cocaína
- Efeitos Fisiológicos das Drogas
- Agentes Adrenérgicos
- Agentes Neurotransmissores
- Mecanismos Moleculares de Ação Farmacológica
- Inibidores de Captação de Neurotransmissores
- Moduladores de transporte de membrana
- Inibidores da Captação Adrenérgica
- Cloridrato de Atomoxetina
Outros números de identificação do estudo
- #4611
- DPMC (Outro identificador: NIDA)
- P50DA009236 (Concessão/Contrato do NIH dos EUA)
- P50-09236-12
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