Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00453804
Other study ID # SUNY UMU IRB # 5371
Secondary ID
Status Completed
Phase Phase 4
First received March 27, 2007
Last updated March 17, 2008
Start date July 2006
Est. completion date June 2007

Study information

Verified date March 2008
Source State University of New York - Upstate Medical University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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


Description:

The overall goal of this project is to improve the treatment of alcohol abuse and dependence in patients with serious mental illness (SMI). SMI for this study is defined as any patient with any of the following diagnoses: schizophrenia, schizoaffective disorder, bipolar type I disorder, major depressive disorder with psychotic features, or psychotic disorder not otherwise specified. Alcohol and other substance use disorders (SUDs) are common among individuals with SMI such as schizophrenia. SUD comorbidity is associated with many adverse consequences. However, to date, few reports have addressed the efficacy of pharmacological treatments for SUDs in this population. Naltrexone pharmacotherapy is an effective treatment for alcohol dependence, but it has not been systematically applied to the care of patients with SMI. This pilot study plans to use a new intramuscular long-acting form of naltrexone that needs to be administered every 4 weeks compared to daily oral naltrexone, which we are also studying in this pilot. This could improve adherence to a medication regimen, which has been shown to be critical to successful naltrexone treatment of alcohol dependence. The proposed project is a 1-year pilot program of research. It is a randomized prospective parallel groups open-label trial of long-acting intramuscular (IM) naltrexone injected every 4 weeks compared to monthly prescriptions of oral naltrexone in a cohort of 20 subjects, ten for each treatment modality. The study is 16 weeks in duration, consisting of a 12-week course of naltrexone plus one follow-up interview at 4 weeks after discontinuation of medication. Voucher-based incentives are provided to all subjects to ensure attendance for medication administration. Weekly motivational counseling sessions are conducted and focus on improving motivation to stop alcohol use. Study outcomes consist of self-report and biological measures of alcohol use as well as measures of psychiatric symptom severity.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date June 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 69 Years
Eligibility Inclusion Criteria:

1. 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;

2. DSM-IV diagnosis of Alcohol Dependence;

3. Level of Drinking:

1. At least four days of drinking in the 30 days prior to consent and/or during screening period OR

2. 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.

4. Currently prescribed antipsychotic medications, mood stabilizers, or antidepressants.

5. 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.

6. 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.

Exclusion Criteria:

1. Inability to give adequate informed consent;

2. Currently taking disulfiram (Antabuse), naltrexone, or acamprosate (Campral);

3. Current DSM-IV diagnosis of Opioid Dependence;

4. 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.

5. Current daily use of non-prescribed opioids.

6. 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;

7. Female patients of childbearing potential who are sexually active, not sterile, and who deny using birth control;

8. Female patients who are pregnant or nursing;

9. 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;

10. AST (aspartate aminotransferase test) levels: If AST is greater than 3x upper limit of normal;

11. Subjects who do not attend required screening appointments. Subsequent exclusion from the study for reasons related to non-attendance will be based on the judgment of the principal investigator;

12. 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;

13. Scheduled surgery within 3 months of intake;

14. Subjects who have pending legal proceedings whose outcome may lead to incarceration within 3 months

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
injectable naltrexone

oral naltrexone


Locations

Country Name City State
United States SUNY Upstate Medical University Syracuse New York

Sponsors (2)

Lead Sponsor Collaborator
State University of New York - Upstate Medical University Cephalon

Country where clinical trial is conducted

United States, 

References & 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

Outcome

Type Measure Description Time frame Safety issue
Primary Primary: Measures of Alcohol Use; Psychiatric Symptom Severity
Secondary adherence to medication, alcohol-related problems, quality of life
See also
  Status Clinical Trial Phase
Recruiting NCT05039489 - A Study on the Brain Mechanism of cTBS in Improving Medication-resistant Auditory Hallucinations in Schizophrenia N/A
Completed NCT05111548 - Brain Stimulation and Cognitive Training - Efficacy N/A
Completed NCT05321602 - Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder Phase 1
Completed NCT04503954 - Efficacy of Chronic Disease Self-management Program in People With Schizophrenia N/A
Completed NCT02831231 - Pilot Study Comparing Effects of Xanomeline Alone to Xanomeline Plus Trospium Phase 1
Completed NCT05517460 - The Efficacy of Auricular Acupressure on Improving Constipation Among Residents in Community Rehabilitation Center N/A
Completed NCT03652974 - Disturbance of Plasma Cytokine Parameters in Clozapine-Resistant Treatment-Refractory Schizophrenia (CTRS) and Their Association With Combination Therapy Phase 4
Recruiting NCT04012684 - rTMS on Mismatch Negativity of Schizophrenia N/A
Recruiting NCT04481217 - Cognitive Factors Mediating the Relationship Between Childhood Trauma and Auditory Hallucinations in Schizophrenia N/A
Completed NCT00212784 - Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25517)(P05935) Phase 3
Completed NCT04092686 - A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia Phase 3
Completed NCT01914393 - Pediatric Open-Label Extension Study Phase 3
Recruiting NCT03790345 - Vitamin B6 and B12 in the Treatment of Movement Disorders Induced by Antipsychotics Phase 2/Phase 3
Recruiting NCT05956327 - Insight Into Hippocampal Neuroplasticity in Schizophrenia by Investigating Molecular Pathways During Physical Training N/A
Terminated NCT03261817 - A Controlled Study With Remote Web-based Adapted Physical Activity (e-APA) in Psychotic Disorders N/A
Terminated NCT03209778 - Involuntary Memories Investigation in Schizophrenia N/A
Completed NCT02905604 - Magnetic Stimulation of the Brain in Schizophrenia or Depression N/A
Recruiting NCT05542212 - Intra-cortical Inhibition and Cognitive Deficits in Schizophrenia N/A
Completed NCT04411979 - Effects of 12 Weeks Walking on Cognitive Function in Schizophrenia N/A
Terminated NCT03220438 - TMS Enhancement of Visual Plasticity in Schizophrenia N/A