Risperidone Long-acting Versus Oral Risperidone in Patients With Schizophrenia and Alcohol Use Disorder
Condition: Schizophrenia; Psychotic Disorders; Substance Abuse; Alcohol Abuse
MeSH terms: Alcoholism; Substance-Related Disorders; Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the efficacy of oral risperidone (Risperdal) to
      risperidone long-acting (Consta) in reducing alcohol use in persons diagnosed with
      schizophrenia or schizoaffective disorder.
    

Detailed description: 
      Comorbid alcohol/substance use disorder (SUD) in people with schizophrenia is a major
      concern, both in view of the high frequency of SUD among patients with schizophrenia and the
      difficulty in managing such patients. Though antipsychotic medications are effective in
      reducing symptoms and impairment in persons with schizophrenia, the typical antipsychotic
      agents are of limited value in controlling alcohol/substance use in these patients.
      Extrapyramidal, dysphoric side effects of conventional neuroleptics may actually promote the
      use of substances in an attempt to counteract these effects. In addition, medication
      non-compliance is common among patients with schizophrenia.

      Novel antipsychotics have altered treatment expectations and outcomes for patients with
      severe forms of schizophrenia. A growing number of studies have assessed the effects of oral
      risperidone in persons with dual disorders. Potential mechanisms of action by which
      risperidone and other atypical antipsychotics could decrease substance use include being less
      likely to cause extrapyramidal side effects than typical agents, improving negative symptoms
      and ameliorating a dysfunction of the brain reward system. Risperidone long-acting injectable
      medication addresses issues of noncompliance, while avoiding peak blood levels of oral
      preparations, thereby minimizing EPS and improving negative symptoms of schizophrenia.
      Risperidone may also facilitate dopamine neurotransmission in the prefrontal cortex and
      correct a hypothesized dysfunction of the brain reward system.

      This study is an open, randomized, controlled study to compare intramuscular long-acting
      risperidone to oral risperidone with blinded ratings to determine whether the long-acting
      form of risperidone has greater efficacy in reducing substance use. Patients with
      schizophrenia or schizoaffective disorder, age 18 to 65, who are taking any single oral
      antipsychotic medication except clozapine or risperidone long-acting may be enrolled.
    

Intervention name(s): Risperidone Long Acting; oral risperidone
Intervention type(s): Drug; Drug
Intervention description(s): Dose 25.00, 37.50 or 50.00 mg q two weeks; 0.50-6.00 mg oral risperidone daily
Other intervention name(s): Risperdal Consta; Risperdal
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Risperidone; Schizophrenia; Substance Use Disorder; Alcohol Use Disorder; Treatment; Schizoaffective Disorder