Research on Individualized Treatment for Alcoholism (RITA)

Indiana University School of Medicine

Status and phase

Completed

Phase 2

Conditions

Alcohol Dependence

Treatments

Drug: naltrexone

Behavioral: Motivational Enhancement Treatment

Behavioral: Broad Spectrum Treatment

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

Identifiers

NCT00523133

R01AA012696-01A1

Details and patient eligibility

About

The purpose of this study was to compare the effects of two psychosocial treatments that differed in scope and intensity (Broad Spectrum Treatment and Motivational Enhancement Treatment) combined with 3 or 6 months of treatment with naltrexone on alcohol drinking behaviors in alcohol dependent patients.

Enrollment

185 patients

Sex

All

Ages

21 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

men and women between the ages of 21-65
current DSM-IV diagnosis of alcohol dependence
abstinent for a minimum of 3 and maximum of 21 days prior to treatment initiation
able to participate in an 18-month outpatient study
live within a one hour or less commute to Fairbanks
fluent in English
women of child-bearing potential must have a negative pregnancy test and use effective contraceptive methods.
score as contemplators or greater on the Readiness For Change Scale

Exclusion criteria

severe hepatic disease (gGGT, SGOT or other liver functions greater than 4 times normal)
opiate use (for any reason) in the last 14 days or a history of opioid dependence in the past year
pregnant or lactating females or those unwilling to use birth control
inability, according to the opinion of the interviewer, to follow medication instructions and safety precautions
comorbid substance dependence (but not abuse) diagnosis in the past 6 months, excluding nicotine or marijuana dependence
concomitant use of medications intended to decrease drinking (e.g. disulfiram)
meeting current DSM criteria for bipolar disorder, schizophrenia, bulimia/anorexia, dementia, major depression