NCT00145847

Brief Summary

The primary purpose of this study is to determine whether naltrexone is effective in the treatment of alcohol dependence and abuse in patients with schizophrenia and schizoaffective disorder. Hypotheses are as follows: hypothesis 1: Naltrexone will be more effective than placebo in reducing alcohol use. hypothesis 2: Patients responding to naltrexone by reducing alcohol use will also show reductions in severity of psychiatric symptoms and utilization of inpatient and emergency psychiatric services. hypothesis 3: Severity of psychiatric symptoms and amount of service utilization will correlate positively with alcohol use.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_4 schizophrenia

Timeline
Completed

Started Apr 2003

Longer than P75 for phase_4 schizophrenia

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

September 1, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 5, 2005

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

January 8, 2013

Status Verified

January 1, 2013

Enrollment Period

5.1 years

First QC Date

September 1, 2005

Last Update Submit

January 7, 2013

Conditions

SchizophreniaMental DisordersAlcohol AbuseAlcoholismAlcohol-related Disorders

Keywords

alcoholschizophrenianaltrexone

Outcome Measures

Primary Outcomes (1)

  • Measures of Alcohol Use

    12 weeks

Secondary Outcomes (1)

  • Psychiatric Symptom Severity

    12 weeks

Study Arms (2)

Naltrexone

ACTIVE COMPARATOR

Naltrexone 50 mg per day, directly administered as 100 mg on Mondays, 100 mg on Wednesdays and 150 mg on Fridays

Drug: Naltrexone or Placebo

Lactose pill

PLACEBO COMPARATOR
Drug: Naltrexone or Placebo

Interventions

Naltrexone or PlaceboDRUG

Naltrexone or Placebo 50 mg per day

Lactose pillNaltrexone

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males or females, age 18 to 69, with a DSM-IV diagnosis of Schizophrenia or Schizoaffective Disorder;
  • DSM-IV diagnosis of Alcohol Abuse or Alcohol Dependence;
  • Level of Drinking: At least four days of drinking in the 30 days prior to consent;
  • Currently prescribed antipsychotic medication;
  • Currently involved in outpatient psychiatric treatment at one of the study sites (Hutchings Psychiatric Center, St. Joseph's Hospital Health Center, VA Medical Center) or at another location in the community at the time of randomization.

You may not qualify if:

  • Inability to give adequate informed consent;
  • Currently taking disulfiram (Antabuse) or naltrexone (ReVia/Depade);
  • Current DSM-IV diagnosis of Opioid Dependence or Opioid Abuse;
  • 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;
  • Current use of prescribed or non-prescribed opioid analgesics, such as methadone, morphine, codeine, heroin, meperidine, and all other opioids.
  • Female patients of childbearing potential who are sexually active, not sterile, and who deny using a form of 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 levels 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 from 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 of intake.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

St. Joseph's Mental Health Services

Syracuse, New York, 13203, United States

Location

Hutchings Psychiatric Center

Syracuse, New York, 13210, United States

Location

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

Veterans Administration Healthcare Center

Syracuse, New York, 13210, United States

Location

Related Publications (10)

  • Batki SL, Dimmock JA, Leontieva L, Bowman ML, Gallinger L, Carey KB, Maisto SA, Canfield KM, McMaster T, Schweizer ML; (abstract) (2005) Recruitment and characteristics of alcohol dependent patients with schizophrenia. Alcoholism Clinical and Experimental Research 29 (5:suppl):78A (abstract 428)

    BACKGROUND

  • Batki SL, Dimmock J, Hameed A, Cornell M, Wade M, Albrecht J, Maisto S, Carey K; (2001) Alcohol use measures in naltrexone treatment of alcohol dependence in schizophrenia: Preliminary analysis. Alcoholism Clinical and Experimental Research, 25 (5:suppl.):93A (abstract 522)

    BACKGROUND

  • Batki SL, Dimmock J, Cornell M, Wade M, Carey K, Maisto S. (2002) Directly observed naltrexone treatment of alcohol dependence in schizophrenia: Preliminary analysis. Alcoholism Clinical and Experimental Research 26 (5:suppl.):83A (abstract 470)

    BACKGROUND

  • Batki SL, Dimmock JA, Wade M, Gately PW, Cornell M, Maisto SA, Carey KB, Ploutz-Snyder R. Monitored naltrexone without counseling for alcohol abuse/dependence in schizophrenia-spectrum disorders. Am J Addict. 2007 Jul-Aug;16(4):253-9. doi: 10.1080/10550490701389732.

    PMID: 17661192BACKGROUND

  • Carey KB, Leontieva L, Dimmock J, Maisto SA, Batki SL. Adapting Motivational Interventions for Comorbid Schizophrenia and Alcohol Use Disorders. Clin Psychol (New York). 2007 Mar;14(1):39-57. doi: 10.1111/j.1468-2850.2007.00061.x.

    PMID: 19081784BACKGROUND

  • Batki, S. L., Dimmock, J. A., Leontieva, L., Bowman, M. L., Gallinger, L., Schweizer, M. L., Carey, K. B., Maisto, S. A., Canfield, K. M., McMaster, T., Ploutz-Snyder, R. (abstract) (2006). Associations among psychiatric symptoms, alcohol severity, and motivation to change in patients with schizophrenia and alcohol use disorders. American Journal on Addictions 15(4):321-322.

    BACKGROUND

  • Batki, S.L., Dimmock, J.A., Leontieva, L., Bowman, M. L., Gallinger, L., Gately, P. W., Carey, K. B., Maisto, S. A., Canfield, K. M., Ploutz-Snyder, R. (abstract) (2006). Co-occurring substance use among patients with alcohol dependence and schizophrenia. Alcoholism Clinical and Experimental Research 30 (6: suppl.):162A (abstract 621)

    BACKGROUND

  • Carey, K.B., Leontieva, L., Dimmock, J., Bowman, M., Gallinger, L., Gately, P., Maisto, S.A., Ploutz-Snyder, R., Batki, S.L. (abstract) (2006). Psychometrics of a short version of the problems assessment for substance-using psychiatric patients (PASSUP-SV) Alcoholism Clinical and Experimental Research 30(6: suppl.):206A (abstract 799)

    BACKGROUND

  • Leontieva, L., Dimmock, J.A., Gately, P., Gallinger, L., Cavallerano, M., DeRycke, S., McMasters, T., Ploutz-Snyder, R., Strutynski, K., Carey, K.B., Maisto, S.A., & Batki, S.L.(abstract). Voucher-based incentives for adherence to research visits in schizophrenia and alcohol dependence.30th Annual Research Society on Alcoholism Meeting, Chicago, IL, USA, July, 2007

    BACKGROUND

  • Leontieva L, Dimmock JA, Gately PW, Gallinger L, Ploutz-Snyder R, Batki SL. Voucher-based incentives for naltrexone treatment attendance in schizophrenia and alcohol use disorders. Psychiatr Serv. 2008 Mar;59(3):310-4. doi: 10.1176/ps.2008.59.3.310.

    PMID: 18308913BACKGROUND

Related Links

MeSH Terms

Conditions

SchizophreniaMental DisordersAlcoholismAlcohol-Related Disorders

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersSubstance-Related DisordersChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

NaloxoneMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Steven L Batki, MD

    State University of New York - Upstate Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 1, 2005

First Posted

September 5, 2005

Study Start

April 1, 2003

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

January 8, 2013

Record last verified: 2013-01

Locations

US(4)