NCT00000448

Brief Summary

This study will assess naltrexone's effectiveness in treating alcoholism in women and provide information on its potential value in treating eating disorders common among alcoholic women. Alcoholic women with and without both eating disorders and depression will be randomly assigned to placebo or naltrexone treatment. Each group will receive behavioral therapy for 12 weeks, with followup 6 months after treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 1995

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1995

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 3, 1999

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2000

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2000

Completed
Last Updated

May 7, 2014

Status Verified

May 1, 2014

Enrollment Period

5.2 years

First QC Date

November 2, 1999

Last Update Submit

May 6, 2014

Conditions

AlcoholismEating Disorder

Outcome Measures

Primary Outcomes (2)

  • Time to first day of drinking

    12 week treatment period

  • Time to first day of heavy drinking

    Defined as consuming 4 or more drinks during the 12-week period

    12 weeks

Secondary Outcomes (5)

  • Percentage of days abstinent

    12 weeks of treatment

  • Percentage of heavy drinking days

    12 weeks of treatment

  • Beck Depression Index

    12 weeks of treatment

  • Obsessive Compulsive Drinking Scale (OCDS)

    Baseline, Month 1, 2, 3

  • Eating Disorder Examination (EDE)

    baseline, month 1, 2, 3

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Subjects were given an inert placebo for 2 days, followed by daily doses of matching placebo for a total of 12 weeks.

Drug: Placebo

Naltrexone

EXPERIMENTAL

Subjects were prescribed 25 mg naltrexone for 2 days, followed by daily doses of 50 mg of naltrexone for a total of 12 weeks.

Drug: naltrexone

Interventions

naltrexoneDRUG

Naltrexone is an opioid receptor antagonist used primarily in the management of alcohol dependence and opioid dependence.

Also known as: Revia, Depade
Naltrexone
PlaceboDRUG

A placebo is a simulated or otherwise medically ineffectual treatment for a disease or other medical condition intended to deceive the recipient.

Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Meets criteria for alcohol dependence. Abstinent from alcohol for a period of at least 5 days.
  • Able to read English and complete study evaluations.
  • A stable residence and a telephone to ensure that subjects can be located during the study.

You may not qualify if:

  • Meets criteria for dependence on another psychoactive substance besides alcohol or nicotine.
  • Regular use of psychoactive drugs except antidepressants.
  • Current use of disulfiram (Antabuse).
  • Psychotic or otherwise severely psychiatrically disabled.
  • Significant underlying medical conditions such as cerebral, renal, thyroid, or cardiac pathology.
  • Abstinent longer than 30 days prior to admission to program.
  • Hepatocellular disease or elevated bilirubin levels.
  • Individuals with present history of opiate abuse or who require the use of opioid analgesics.
  • Women who are pregnant, nursing, or not using a reliable method of birth control.
  • Women who are significantly overweight or significantly underweight.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Substance Abuse Treatment Unit, Yale University

New Haven, Connecticut, 06511, United States

Location

Related Publications (1)

  • O'Malley SS, Sinha R, Grilo CM, Capone C, Farren CK, McKee SA, Rounsaville BJ, Wu R. Naltrexone and cognitive behavioral coping skills therapy for the treatment of alcohol drinking and eating disorder features in alcohol-dependent women: a randomized controlled trial. Alcohol Clin Exp Res. 2007 Apr;31(4):625-34. doi: 10.1111/j.1530-0277.2007.00347.x.

    PMID: 17374042RESULT

Related Links

MeSH Terms

Conditions

AlcoholismFeeding and Eating Disorders

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

NaloxoneMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Stephanie S O'Malley, PhD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 1999

First Posted

November 3, 1999

Study Start

October 1, 1995

Primary Completion

December 1, 2000

Study Completion

December 1, 2000

Last Updated

May 7, 2014

Record last verified: 2014-05

Locations

US(1)