Skip to content

Post-Treatment Effects of Naltrexone

Post-Treatment Effects of Naltrexone

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00006449
Enrollment
160
Registered
2000-11-07
Start date
2000-09-30
Completion date
2006-07-31
Last updated
2010-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcoholism

Brief 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.

Interventions

BEHAVIORALmotivational enhancement therapy

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
CollaboratorNIH
Indiana University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026