- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00218543
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
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Iscrizione (Effettivo)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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New York
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New York, New York, Stati Uniti, 10032
- Research Foundation for Mental Hygiene, Inc.
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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the Adult ADHD Rating Scale (AARS) (30% Reduction)
Lasso di tempo: 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)
Lasso di tempo: 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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Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Herbert Kleber, MD, New York State Psychiatric Institute
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Disordini mentali
- Disturbi indotti chimicamente
- Processi patologici
- Malattie del sistema nervoso
- Disturbi Correlati a Sostanze
- Manifestazioni neurologiche
- Discinesia
- Disturbi da deficit di attenzione e comportamento dirompente
- Disturbi del neurosviluppo
- Patologia
- Disturbo da deficit di attenzione con iperattività
- Ipercinesia
- Disturbi correlati alla cocaina
- Effetti fisiologici delle droghe
- Agenti adrenergici
- Agenti neurotrasmettitori
- Meccanismi molecolari dell'azione farmacologica
- Inibitori dell'assorbimento dei neurotrasmettitori
- Modulatori di trasporto a membrana
- Inibitori dell'assorbimento adrenergico
- Atomoxetina cloridrato
Altri numeri di identificazione dello studio
- #4611
- DPMC (Altro identificatore: NIDA)
- P50DA009236 (Sovvenzione/contratto NIH degli Stati Uniti)
- P50-09236-12
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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