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Ondansetron+ Cognitive Behavioral Therapy · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Ondansetron | EXPERIMENTAL | Arm 1 = Ondansetron 4 mcg/kg b.i.d.+ Cognitive behavioral therapy |
| Placebo | PLACEBO_COMPARATOR | Arm 2 = Placebo + Cognitive behavioral therapy |
| Name | Type | Description |
|---|---|---|
| Ondansetron + Cognitive Behavioral Therapy | DRUG | 13 week outpatient trial |
| Placebo + Cognitive Behavioral Therapy | DRUG | 13 week outpatient trial |
Inclusion Criteria: * Males and females who have given written informed consent. * Ages 18 years and above and, must weigh at least 40 Kg and no more than 140 Kg * Good physical health as determined by a complete physical examination, an EKG within normal limits, and laboratory screening tests with...
Ondansetron + Cognitive Behavioral Therapy is an investigational combination being studied for the treatment of Alcohol Dependence. It combines the small molecule ondansetron with cognitive behavioral therapy. The therapy is currently in Phase 3 clinical development and is not yet approved by the FDA.
Ondansetron is a serotonin 5-HT3 receptor antagonist, and the combination with cognitive behavioral therapy is being evaluated for Alcohol Dependence. The treatment approach targets the serotonergic system to potentially reduce alcohol craving and consumption, though the exact mechanism in this context is still under investigation.
Ondansetron + Cognitive Behavioral Therapy is being developed by Johnson & Johnson, a company traded on the NYSE under the ticker JNJ. The combination therapy is currently in Phase 3 clinical trials for Alcohol Dependence.
Ondansetron + Cognitive Behavioral Therapy is in Phase 3 clinical development for Alcohol Dependence. It is an investigational therapy, meaning it has not yet received FDA approval and is still undergoing clinical trials to establish its safety and efficacy.
Ondansetron + Cognitive Behavioral Therapy has one completed Phase 3 clinical trial, identified as NCT00382642, titled 'Pharmacological Treatment for Alcoholism'. This randomized, double-blind, placebo-controlled study enrolled 283 participants with Alcohol Dependence in the United States and included biomarker selection.
Ondansetron + Cognitive Behavioral Therapy is a combination therapy that pairs the small molecule ondansetron with cognitive behavioral therapy. It is distinct from ondansetron used alone, as the combination approach integrates pharmacological treatment with psychotherapy to address Alcohol Dependence.