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
Aperçu de l'étude
Statut
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
-
-
New York
-
New York, New York, États-Unis, 10032
- Research Foundation for Mental Hygiene, Inc.
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Atomoxetine
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
the Adult ADHD Rating Scale (AARS) (30% Reduction)
Délai: baseline compared to rating at week 12 or last rating during study participation
|
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)
Délai: measured during 12 weeks or length of study participation
|
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
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Herbert Kleber, MD, New York State Psychiatric Institute
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Les troubles mentaux
- Troubles induits chimiquement
- Processus pathologiques
- Maladies du système nerveux
- Troubles liés à une substance
- Manifestations neurologiques
- Dyskinésies
- Déficit de l'attention et troubles du comportement perturbateur
- Troubles neurodéveloppementaux
- Maladie
- Trouble déficitaire de l'attention avec hyperactivité
- Hyperkinésie
- Troubles liés à la cocaïne
- Effets physiologiques des médicaments
- Agents adrénergiques
- Agents neurotransmetteurs
- Mécanismes moléculaires de l'action pharmacologique
- Inhibiteurs de l'absorption des neurotransmetteurs
- Modulateurs de transport membranaire
- Inhibiteurs de l'absorption adrénergique
- Chlorhydrate d'atomoxétine
Autres numéros d'identification d'étude
- #4611
- DPMC (Autre identifiant: NIDA)
- P50DA009236 (Subvention/contrat des NIH des États-Unis)
- P50-09236-12
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .