Clinical trial NCT00130923: Risperidone Long-acting Versus Oral Risperidone in Patients With Schizophrenia and Alcohol Use Disorder
Official title: Risperidone Long-Acting for Alcohol and Schizophrenia Treatment (R-LAST)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Psychotic Disorders
Substance Abuse
Alcohol Abuse
Keywords: Risperidone
Schizophrenia
Substance Use Disorder
Alcohol Use Disorder
Treatment
Schizoaffective Disorder
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: Janssen, LP
First posted: 2005-08-16
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Ages 18-65
* Schizophrenia or schizoaffective disorder
* Meets the Structured Clinical Interview for DSM-IV (SCID) criteria for an alcohol use disorder
* Alcohol use on at least 5 days during the 4 weeks prior to randomization
* Patient is medically stable to start either form of risperidone.

Exclusion Criteria:

* Current treatment with clozapine.
* Current treatment with injectable risperidone long-acting.
* Currently pregnant, planning to become pregnant, or unwilling to use an acceptable form of birth control.
* Change in medications (dose of current medication, discontinuation of medication, or new medication) in past 30 days.
* History of or current breast cancer.
* History of intolerance of or allergy to risperidone or risperidone long-acting.
* Currently residing in a residential program designed to treat substance use disorders.
* Current treatment with long-acting, injectable antipsychotic medication will require a review by the medication adjustment group before entering the client into the study.
* Past treatment with risperidone long-acting will require a review by the medication adjustment group before entering the client into the study.
* Treatment at baseline with a second antipsychotic medication will require a review by the medication adjustment group before entering the client into the study.
* Treatment at baseline with a psychotropic agent proposed to curtail substance use will require a review by the medication adjustment group before entering the client into the study.
* Patients who, in the opinion of the investigator, are judged unsuitable to participate in the study.

Primary outcomes:
measure: Change Over Time in Frequency of Heavy Drinking Days (Used to Evaluate Treatment Efficacy)
timeFrame: 6 months
Secondary outcomes:
measure: Average Over Time of Frequency of Drinking Days (Used to Evaluate Treatment Efficacy)
timeFrame: 6 months
measure: Average Over Time of Severity of Illness and Global Improvement (Used to Evaluate Treatment Efficacy)
timeFrame: 6 months
measure: Average Over Time of Positive and Negative Symptoms (Used to Evaluate Treatment Efficacy)
timeFrame: 6 months
measure: Average Over Time of Global Functioning (Used to Evaluate Treatment Efficacy)
timeFrame: 6 months
measure: Number of Participants With Medication Adherence
timeFrame: 6 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: JMH Mental Health Center, University of Miami
state: Florida
city: Kansas City
country: United States
facility: School of Pharmacy, Univ. of Missouri Kansas City
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Lebanon
country: United States
facility: West Central Behavioral Health
state: New Hampshire
city: Manchester
country: United States
facility: Mental Health Center of Greater Manchester
state: New Hampshire
city: Nashua
country: United States
facility: Center for Psychiatric Advancement
state: New Hampshire
city: Columbia
country: United States
facility: University of South Carolina
state: South Carolina
city: White River Junction
country: United States
facility: White River Junction Veterans Admininistration Medical Center
state: Vermont
Study officials:
affiliation: Dartmouth Medical School, Dartmouth College
name: Alan I. Green, MD
role: PRINCIPAL_INVESTIGATOR
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