Phase 4
N=95
Risperidone Long-acting Versus Oral Risperidone in Patients With Schizophrenia and Alcohol Use Disorder
Schizophrenia · Psychotic Disorders · Substance Abuse · Alcohol Abuse
Bottom Line
View on ClinicalTrials.gov: NCT00130923 ↗Enrolled (actual)
95
Serious AEs
29.5%
Results posted
Oct 2012
Primary outcome: Primary: Change Over Time in Frequency of Heavy Drinking Days (Used to Evaluate Treatment Efficacy) — -.11; .68 heavy drinking days per week — p=0.054
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Risperidone Long Acting (Drug); oral risperidone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dartmouth-Hitchcock Medical Center
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change Over Time in Frequency of Heavy Drinking Days (Used to Evaluate Treatment Efficacy) |
-.11; .68 | 0.054 |
| SECONDARY Average Over Time of Frequency of Drinking Days (Used to Evaluate Treatment Efficacy) |
2.84; 3.46 | .035 sig |
| SECONDARY Average Over Time of Severity of Illness and Global Improvement (Used to Evaluate Treatment Efficacy) |
4.02; 3.96 | .57 |
| SECONDARY Average Over Time of Positive and Negative Symptoms (Used to Evaluate Treatment Efficacy) |
78.2; 75.5 | .32 |
| SECONDARY Average Over Time of Global Functioning (Used to Evaluate Treatment Efficacy) |
50.8; 49.9 | .44 |
| SECONDARY Number of Participants With Medication Adherence |
43; 28 | .003 sig |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00130923). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.