NCT00280813

Brief Summary

The purpose of the study is to evaluate a new treatment to help patients who have problems because of their use of alcohol. The treatment is called Behavioral Treatment for Alcohol Abuse in Schizophrenia (BTAAS).We are interested in determining whether BTAAS is more effective in reducing use than a supportive control treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started Mar 2004

Typical duration for not_applicable 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

March 1, 2004

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 19, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 23, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

April 6, 2020

Status Verified

April 1, 2020

Enrollment Period

3.2 years

First QC Date

January 19, 2006

Last Update Submit

April 2, 2020

Conditions

SchizophreniaMood DisordersAlcohol AbuseAlcohol Dependence

Keywords

treatmentdual diagnosis

Outcome Measures

Primary Outcomes (1)

  • Symptom ratings, addiction severity, quality of life, social functioning & motivation to change: baseline and post-treatment.

    1 year

Secondary Outcomes (1)

  • Saliva test & Urinalysis: baseline, post-treatment and at each treatment session.

    1 year

Study Arms (1)

Supportive Treatment in Alcohol Recovery (STAR)

ACTIVE COMPARATOR
Behavioral: Supportive Treatment in Addiction Recovery (STAR)

Interventions

Supportive Treatment in Addiction Recovery (STAR)BEHAVIORAL
Supportive Treatment in Alcohol Recovery (STAR)

Eligibility Criteria

Age22 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • DSM-IV diagnosis of schizophrenia or schizoaffective disorder OR other severe disorder including bipolar disorder, major depression, or severe anxiety disorder (by definition, the patient has worked 25% or less of the past year; and/or the patient received payment for mental disability)
  • Current (last month) Alcohol Abuse or Dependence or Alcohol Abuse or Dependence criteria met within the last 3 months as determined by the Structured Clinical Interview for DSM-IV.
  • Ability to provide informed consent
  • Stable housing

You may not qualify if:

  • Current neurological disorder or cognitive impairment due to head injury or loss of consciousness that would impact ability to effectively participate in the intervention
  • Mental retardation as indicated by chart review
  • inability to effectively participate in the baseline assessments due to intoxication or psychiatric symptoms on two successive appointments
  • patient is homeless.
  • Inability to attend scheduled treatment sessions on a regular basis for any reason, or to appropriately participate in research activities due to behavioral or psychiatric problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Healthcare for the Homeless

Baltimore, Maryland, 21201, United States

Location

University of Maryland, Baltimore

Baltimore, Maryland, 21201, United States

Location

VA Maryland Healthcare System

Baltimore, Maryland, 21201, United States

Location

Mosaic Community Services Inc.

Catonsville, Maryland, 21228, United States

Location

Related Publications (6)

  • Bellack AS, DiClemente CC. Treating substance abuse among patients with schizophrenia. Psychiatr Serv. 1999 Jan;50(1):75-80. doi: 10.1176/ps.50.1.75.

    PMID: 9890583BACKGROUND

  • Bellack AS, Gearon JS. Substance abuse treatment for people with schizophrenia. Addict Behav. 1998 Nov-Dec;23(6):749-66. doi: 10.1016/s0306-4603(98)00066-5.

    PMID: 9801714BACKGROUND

  • Bennett ME. Interrelationship of substance abuse and mental health problems. In Miller WR & Weisner C (Eds.), Changing substance abuse through health and social systems. New York: Kluwer/Plenum, 2003.

    BACKGROUND

  • Bennett ME, Barnett, B.Adult psychopathology and diagnosis: Dual-diagnosis. In M. Hersen & SM Turner (Eds), Adult psychopathology and diagnosis, fourth edition. NY: Kluwer/Plenum, 2003.

    BACKGROUND

  • Bennett ME, Bellack AS, Gearon JS. Treating substance abuse in schizophrenia. An initial report. J Subst Abuse Treat. 2001 Mar;20(2):163-75. doi: 10.1016/s0740-5472(00)00167-7.

    PMID: 11306219BACKGROUND

  • Miller WR, Andrews, NA, Wilbourne P, Bennett ME (1998). A wealth of alternatives: Effective treatments for alcohol problems. In Miller WR and Healther N. (Eds.). Treating addicting behaviors, second edition. NY: Plenum Press, 1998.

    BACKGROUND

MeSH Terms

Conditions

SchizophreniaMood DisordersAlcoholism

Condition Hierarchy (Ancestors)

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

Study Officials

  • Melanie Bennett, Ph.D.

    University of Maryland, Baltimore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 19, 2006

First Posted

January 23, 2006

Study Start

March 1, 2004

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

April 6, 2020

Record last verified: 2020-04

Locations

US(4)