Injectable Versus Oral Naltrexone Treatment of Alcohol Dependence In Serious Mental Illness (SMI)
vivitrol
1 other identifier
interventional
15
1 country
1
Brief Summary
The primary aim of this study is to determine the feasibility of long-acting injectable naltrexone administration in a clinical trial in patients with SMI who also have a diagnosis of alcohol dependence. Secondary aims include providing a preliminary assessment of the tolerability and safety of long-acting injectable naltrexone as compared with oral naltrexone in patients with SMI who also have a diagnosis of alcohol dependence. An additional aim is to provide a preliminary assessment of the efficacy of long-acting injectable naltrexone as compared with oral naltrexone in reducing alcohol use from baseline levels
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jul 2006
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 27, 2007
CompletedFirst Posted
Study publicly available on registry
March 29, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2007
CompletedMarch 18, 2008
March 1, 2008
March 27, 2007
March 17, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary: Measures of Alcohol Use; Psychiatric Symptom Severity
Secondary Outcomes (1)
adherence to medication, alcohol-related problems, quality of life
Interventions
Eligibility Criteria
You may qualify if:
- Males or females, age 18 to 69, with a DSM-IV diagnosis of Schizophrenia, Schizoaffective Disorder, Major Depressive Disorder (MDD) with Psychotic features, Bipolar Type I or Type II Disorder, or Psychosis not Otherwise Specified (NOS) Disorder;
- DSM-IV diagnosis of Alcohol Dependence;
- Level of Drinking:
- At least four days of drinking in the 30 days prior to consent and/or during screening period OR
- For prospective subjects who are currently in an inpatient or residential facility or recently discharged within 30 days prior to consent: At least 4 days of drinking during the period of time immediately prior to inpatient admission and/or during post-discharge.
- Currently prescribed antipsychotic medications, mood stabilizers, or antidepressants.
- One negative urine screen for opiates prior to start of medication and a self-report of no opioid use for at least 1 week prior to starting medication.
- Currently involved in outpatient psychiatric treatment at one of the study sites (Hutchings Psychiatric Center, SUNY Upstate Adult Psychiatric Clinic, St. Joseph's Hospital, VA Medical Center) or at another location in the community.
You may not qualify if:
- Inability to give adequate informed consent;
- Currently taking disulfiram (Antabuse), naltrexone, or acamprosate (Campral);
- Current DSM-IV diagnosis of Opioid Dependence;
- Current regular use of prescribed opioid analgesics, such as methadone, morphine, codeine, meperidine, and all other opioids. If the subject reports taking a prescribed opioid analgesic only occasionally, the study physician or nurse practitioner will contact the prescribing physician regarding the safety of study participation and the possibility of using an alternative. The principal investigator will make the final determination after obtaining the primary physician's recommendation regarding this criterion.
- Current daily use of non-prescribed opioids.
- Currently taking ibuprofen or other potentially hepatotoxic medications in amount and/or frequency judged by the Principal Investigator to pose clinically significant added risk of hepatic injury;
- Female patients of childbearing potential who are sexually active, not sterile, and who deny using birth control;
- Female patients who are pregnant or nursing;
- Significant unstable medical problems, including any significant unstable psychiatric disorders. The study physician conducting the medical history and physical exam will exclude such clinically unstable individuals;
- AST (aspartate aminotransferase test) levels: If AST is greater than 3x upper limit of normal;
- In need of acute medical detoxification from alcohol in the judgment of the study physician based on results a score of 12 or more on the Clinical Institute Withdrawal Assessment of Alcohol Scale Based on DSM-III-R (CIWA-AD) and other information obtained;
- Scheduled surgery within 3 months of intake;
- Subjects who have pending legal proceedings whose outcome may lead to incarceration within 3 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
SUNY Upstate Medical University
Syracuse, New York, 13210, United States
Related Publications (1)
Batki, S.L., Dimmock, J.A., Cavallerano, M., Leontieva, L., DeRycke, S., Ploutz-Snyder, R., Gallinger, L., Strutynski, K., Canfield, K., Carey, K.B., Maisto, S.A., Keegan, P., McMaster, T. (under review) (poster presentation) A pilot trial of oral versus long-acting injectable naltrexone in serious mental illness. Research Society on Alcoholism, 30th Annual Scientific Meeting 2007
RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Steven L Batki, MD
SUNY Upstate Medical University, Psychiatry Department
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 27, 2007
First Posted
March 29, 2007
Study Start
July 1, 2006
Study Completion
June 1, 2007
Last Updated
March 18, 2008
Record last verified: 2008-03