Alcohol Use Disorders in Schizophrenia

Schizophrenia Clinical Trial

Official title:

Treatment of Alcohol Use Disorders in Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00280813
• Other study ID #: 21942
• Status: Completed
• Phase: N/A
• Start date: March 2004
• Est. completion date: May 2007

Study information

• Verified date: April 2020
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Alcohol abuse and dependence in people with schizophrenia is a serious public health problem that is associated with poor treatment compliance, increased rates of relapse, increased levels of violence, and poor overall health and life functioning. Treating alcohol use disorders in people with schizophrenia is especially problematic, as schizophrenia is marked by symptoms and neurocognitive and psychosocial deficits that make it difficult for patients to engage in the higher level cognitive processes or the sustained, self-directed behaviors generally required to reduce drinking. To date there are no interventions for alcohol use disorders with solid empirical support that have been designed for or adapted to meet the needs of this multiply-handicapped population. In this study we will develop and pilot test a multifaceted behavioral intervention for treating schizophrenia patients with alcohol use disorders that will incorporate strategies that have been found to be effective in reducing drinking, but tailor them to meet the needs of this population. The intervention will contain several components, including: (1) pre-treatment motivational interviewing to increase engagement and motivation; (2) short-term goal setting at each session; (3) social skills and alcohol refusal skills training; (4) education and coping skills training for managing depression, stress and other forms of negative affect; (5) relapse prevention training; (6) case management aimed at networking with social supports in the participant's environment and linking patients with activities and social networks in the community in order to create a reinforcing, non-drinking environment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Alcohol Abuse
• Alcohol Dependence
• Alcoholism
• Mood Disorders
• Schizophrenia

Intervention

Behavioral:
• Supportive Treatment in Addiction Recovery (STAR)

Locations

Country	Name	City	State
United States	Healthcare for the Homeless	Baltimore	Maryland
United States	University of Maryland, Baltimore	Baltimore	Maryland
United States	VA Maryland Healthcare System	Baltimore	Maryland
United States	Mosaic Community Services Inc.	Catonsville	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

References & Publications (6)

Bellack AS, DiClemente CC. Treating substance abuse among patients with schizophrenia. Psychiatr Serv. 1999 Jan;50(1):75-80. Review. — View Citation

Bellack AS, Gearon JS. Substance abuse treatment for people with schizophrenia. Addict Behav. 1998 Nov-Dec;23(6):749-66. Review. — View Citation

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.

Bennett ME, Bellack AS, Gearon JS. Treating substance abuse in schizophrenia. An initial report. J Subst Abuse Treat. 2001 Mar;20(2):163-75. — View Citation

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.

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptom ratings, addiction severity, quality of life, social functioning & motivation to change: baseline and post-treatment.		1 year
Secondary	Saliva test & Urinalysis: baseline, post-treatment and at each treatment session.		1 year