Overview

Post-Treatment Effects of Naltrexone

Status:
Completed
Trial end date:
2006-07-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Indiana University
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Treatments:
Naltrexone
Criteria
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.