Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
160 participants
INTERVENTIONAL
1995-10-31
2000-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Subjects were given an inert placebo for 2 days, followed by daily doses of matching placebo for a total of 12 weeks.
Placebo
A placebo is a simulated or otherwise medically ineffectual treatment for a disease or other medical condition intended to deceive the recipient.
Naltrexone
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
Naltrexone is an opioid receptor antagonist used primarily in the management of alcohol dependence and opioid dependence.
Interventions
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naltrexone
Naltrexone is an opioid receptor antagonist used primarily in the management of alcohol dependence and opioid dependence.
Placebo
A placebo is a simulated or otherwise medically ineffectual treatment for a disease or other medical condition intended to deceive the recipient.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
50 Years
FEMALE
No
Sponsors
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National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NIH
Yale University
OTHER
Responsible Party
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Principal Investigators
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Stephanie S O'Malley, PhD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Substance Abuse Treatment Unit, Yale University
New Haven, Connecticut, United States
Countries
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References
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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.
Related Links
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Other Identifiers
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NIAAAOMA10225
Identifier Type: -
Identifier Source: org_study_id
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