Naltrexone Treatment for Alcoholic Women

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Primary Purpose

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

naltrexone

Placebo

About this trial

This is an interventional treatment trial for Alcoholism

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

Substance Abuse Treatment Unit, Yale University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Naltrexone

Arm Description

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

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

Outcomes

Primary Outcome Measures

Time to first day of drinking

Time to first day of heavy drinking

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

Secondary Outcome Measures

Percentage of days abstinent

Percentage of heavy drinking days

Beck Depression Index

The Beck Depression Inventory (BDI, BDI-1A, BDI-II), created by Dr. Aaron T. Beck, is a 21-question multiple-choice self-report inventory. Higher total scores indicate more severe depressive symptoms. This was administered bi-weekly throughout the treatment period.

Obsessive Compulsive Drinking Scale (OCDS)

The OCDS was developed to reflect obsessionality and compulsivity related to craving and drinking behavior.

Eating Disorder Examination (EDE)

The Eating Disorder Examination Interview (EDE) devised by Cooper & Fairburn (1987) is a semi-structured interview conducted by a clinician in the assessment of an eating disorder. The questions concern the frequency in which the patient engages in behaviors indicative of an eating disorder over a 28 day period. The test is scored on a 7 point scale from 0-6. With a zero score indicating not having engaged in the questioned behavior.

Full Information

NCT ID

NCT00000448

First Posted

November 2, 1999

Last Updated

May 6, 2014

Sponsor

Yale University

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

1. Study Identification

Unique Protocol Identification Number

NCT00000448

Brief Title

Naltrexone Treatment for Alcoholic Women

Official Title

Naltrexone: Consummatory Behaviors in Alcoholic Women

Study Type

Interventional

2. Study Status

Record Verification Date

May 2014

Overall Recruitment Status

Completed

Study Start Date

October 1995 (undefined)

Primary Completion Date

December 2000 (Actual)

Study Completion Date

December 2000 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yale University

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

Detailed Description

Background: Despite important gender differences in drinking patterns, physiological effects of alcohol, and co-occurring psychiatric conditions, relatively little is known about the efficacy of naltrexone for the treatment of alcohol dependence in women. This study investigated the safety and efficacy of naltrexone in combination with Cognitive Behavioral Coping Skills Therapy (CBCST) in a sample of alcohol-dependent women, some with comorbid eating pathology. Methods: One hundred three women meeting DSM-IV criteria for alcohol dependence (29 with comorbid eating disturbances) were randomized to receive either naltrexone or placebo for 12 weeks in addition to weekly group CBCST.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alcoholism, Eating Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

160 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Naltrexone

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

naltrexone

Other Intervention Name(s)

Revia, Depade

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Time to first day of drinking

Time Frame

12 week treatment period

Title

Time to first day of heavy drinking

Description

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

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Percentage of days abstinent

Time Frame

12 weeks of treatment

Title

Percentage of heavy drinking days

Time Frame

12 weeks of treatment

Title

Beck Depression Index

Description

The Beck Depression Inventory (BDI, BDI-1A, BDI-II), created by Dr. Aaron T. Beck, is a 21-question multiple-choice self-report inventory. Higher total scores indicate more severe depressive symptoms. This was administered bi-weekly throughout the treatment period.

Time Frame

12 weeks of treatment

Title

Obsessive Compulsive Drinking Scale (OCDS)

Description

The OCDS was developed to reflect obsessionality and compulsivity related to craving and drinking behavior.

Time Frame

Baseline, Month 1, 2, 3

Title

Eating Disorder Examination (EDE)

Description

The Eating Disorder Examination Interview (EDE) devised by Cooper & Fairburn (1987) is a semi-structured interview conducted by a clinician in the assessment of an eating disorder. The questions concern the frequency in which the patient engages in behaviors indicative of an eating disorder over a 28 day period. The test is scored on a 7 point scale from 0-6. With a zero score indicating not having engaged in the questioned behavior.

Time Frame

baseline, month 1, 2, 3

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stephanie S O'Malley, PhD

Organizational Affiliation

Yale School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Substance Abuse Treatment Unit, Yale University

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06511

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

17374042

Citation

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.

Results Reference

result

Alcoholism, Eating Disorder

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial