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| ID | Type | Description | Link |
|---|---|---|---|
| R01AA010225 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| naltrexone | Drug | Naltrexone is an opioid receptor antagonist used primarily in the management of alcohol dependence and opioid dependence. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of days abstinent | 12 weeks of treatment | |
| Percentage of heavy drinking days | 12 weeks of treatment | |
| Beck Depression Index |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephanie S O'Malley, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Substance Abuse Treatment Unit, Yale University | New Haven | Connecticut | 06511 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17374042 | Result | 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. |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D001068 | Feeding and Eating Disorders |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D009271 | Naltrexone |
| ID | Term |
|---|---|
| D009270 | Naloxone |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 |
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| Placebo | Drug | A placebo is a simulated or otherwise medically ineffectual treatment for a disease or other medical condition intended to deceive the recipient. |
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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. |
| 12 weeks of treatment |
| Obsessive Compulsive Drinking Scale (OCDS) | The OCDS was developed to reflect obsessionality and compulsivity related to craving and drinking behavior. | Baseline, Month 1, 2, 3 |
| 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. | baseline, month 1, 2, 3 |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |