Research on Individualized Treatment for Alcoholism

Posttreatment Effects of Naltrexone

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00523133

Acronym

RITA

Enrollment

185

Registered

2007-08-31

Start date

2000-09-30

Completion date

2005-07-31

Last updated

2007-08-31

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

Conditions

Alcohol Dependence

Keywords

alcoholism, naltrexone, motivational enhancement therapy

Brief summary

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.

Interventions

DRUGnaltrexone

50 mg naltrexone daily for 3 months

BEHAVIORALBroad Spectrum Treatment

8-14, one hour sessions over 6 months

BEHAVIORALMotivational Enhancement Treatment

4, 20 minute sessions over 3 months

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

21 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
Percent Days Abstinent	18 months

Secondary

Measure	Time frame
Percent Heavy Drinking Days	18 months

Countries

United States

Outcome results

None listed

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