Post-Treatment Effects of Naltrexone

Indiana University

Status and phase: Completed; Phase 4

Conditions: Alcoholism

Treatments: Drug: naltrexone (Revia); Behavioral: broad spectrum treatment; Behavioral: motivational enhancement therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00006449

NIAAADAV12696

R01AA012696 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The aims of this protocol are to compare 3 and 6 months of naltrexone treatment coupled with two psychotherapies that differ in scope and intensity. The effect of these treatments will be assessed with patients who differ in their psychosocial need and resources at their disposal, and in their level of cravings for alcohol.

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Meets current diagnosis of alcohol dependence and have been abstinent for a minimum of 3 and maximum of 21 days prior to treatment
• Must be able to participate in an 18-month outpatient study, and live within a one hour or less commute to treatment facility.
• Must be fluent in English.
• Women of childbearing potential must have a negative pregnancy test.

Exclusion criteria

• Severe hepatic disease or a liver function test greater than 4 times normal.
• Opiate use in the last 14 days or a history of opioid dependence in the past year.
• Pregnant or lactating females who are not using a reliable method of birth control.
• Inability to follow medication instructions and safety precautions.
• Comorbid substance dependence diagnosis in the past 6-months, excluding nicotine or marijuana dependence.
• Use of medications intended to decrease drinking.
• Meets criteria for bipolar disorder, schizophrenia, bulimia/anorexia, dementia, major depression.