Naltrexone Treatment for Alcoholic Women
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|ClinicalTrials.gov Identifier: NCT00000448|
Recruitment Status : Completed
First Posted : November 3, 1999
Last Update Posted : May 7, 2014
|Condition or disease||Intervention/treatment||Phase|
|Alcoholism Eating Disorder||Drug: naltrexone Drug: Placebo||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Naltrexone: Consummatory Behaviors in Alcoholic Women|
|Study Start Date :||October 1995|
|Actual Primary Completion Date :||December 2000|
|Actual Study Completion Date :||December 2000|
Placebo Comparator: Placebo
Subjects were given an inert placebo for 2 days, followed by daily doses of matching placebo for a total of 12 weeks.
A placebo is a simulated or otherwise medically ineffectual treatment for a disease or other medical condition intended to deceive the recipient.
Subjects were prescribed 25 mg naltrexone for 2 days, followed by daily doses of 50 mg of naltrexone for a total of 12 weeks.
Naltrexone is an opioid receptor antagonist used primarily in the management of alcohol dependence and opioid dependence.
- Time to first day of drinking [ Time Frame: 12 week treatment period ]
- Time to first day of heavy drinking [ Time Frame: 12 weeks ]Defined as consuming 4 or more drinks during the 12-week period
- Percentage of days abstinent [ Time Frame: 12 weeks of treatment ]
- Percentage of heavy drinking days [ Time Frame: 12 weeks of treatment ]
- Beck Depression Index [ Time Frame: 12 weeks of treatment ]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) [ Time Frame: Baseline, Month 1, 2, 3 ]The OCDS was developed to reflect obsessionality and compulsivity related to craving and drinking behavior.
- Eating Disorder Examination (EDE) [ Time Frame: baseline, month 1, 2, 3 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000448
|United States, Connecticut|
|Substance Abuse Treatment Unit, Yale University|
|New Haven, Connecticut, United States, 06511|
|Principal Investigator:||Stephanie S O'Malley, PhD||Yale School of Medicine|