A 6-month controlled naltrexone study: combined effect with cognitive behavioral therapy in outpatient treatment of alcohol dependence.

BACKGROUND: In several studies, patients with alcohol dependence treated with the opioid antagonist naltrexone have shown fewer relapses to heavy drinking than those receiving placebo. An interaction between the naltrexone effect and the type of psychological therapy has been observed. METHODS: A 6-month, double-blind, placebo-controlled, parallel-group study was performed at 10 different investigation sites. After a placebo run-in period of 1 week, 118 patients were randomized into 4 treatment groups-50 mg of naltrexone daily or placebo in combination with either cognitive behavioral therapy (CBT) or supportive therapy. The CBT was performed over nine sessions according to the manual of Project MATCH (Matching Alcoholism Treatments to Client Heterogeneity). The supportive therapy was defined as "the treatment as usual." Alcohol consumption, craving, carbohydrate-deficient transferrin, medication compliance by tablet count, and adverse clinical events were assessed at all visits. Other liver enzymes and psychiatric symptoms were also determined. RESULTS: Ninety-one (77%) patients completed the study, and 92 (78%) were 80% compliant with the medication regimen. A lower percentage of heavy-drinking days was shown in the naltrexone group (p = 0.045) compared with the placebo group, as was a lower craving score (p = 0.029). These results are supported by the lower levels of liver enzyme activities (p < 0.010 for aspartate aminotransferase, alanine aminotransferase, and gamma-glutamyltransferase), but not by the carbohydrate-deficient transferrin levels, in the naltrexone group. The mean time period before the first day of heavy drinking was longer for the group treated with CBT (p = 0.010), especially in combination with naltrexone (p = 0.007). Naltrexone was well tolerated, and no patients discontinued the study due to side effects. CONCLUSIONS: This study supports the effect of naltrexone in outpatient treatment of alcohol dependence and suggests that a beneficial interaction effect with CBT can be expected.

A 2-year follow-up of 120 Swedish female alcoholics treated early in their drinking career: prediction of drinking outcome.

BACKGROUND: One hundred twenty women alcoholics recruited to a treatment program called EWA (Early Treatment for Women With Alcohol Addiction) were studied. The selected women were not previously treated for alcohol abuse. METHODS: The women were followed up by use of a structured personal interview, biomarkers sensitive for alcohol abuse (i.e., glutamyl transpeptidase), and questionnaires, by using defined criteria for abstinence, social drinking, satisfactory drinking outcome, and unsatisfactory drinking outcome. RESULTS: Drinking outcome was good (i.e., total abstinence, social drinking, or satisfactory drinking outcome) for 67% of the women during the total follow-up time, by use of strict criteria for relapse. The results were corroborated by the biomarkers. Similar results were reported from two previously studied groups of women from the same department. However, the frequency of abstinence was higher and social drinking was significantly lower among this sample of women. Daily drinking, the use of sedatives, and a long duration of pretreatment alcohol abuse predicted an unfavorable outcome. However, a long duration of outpatient treatment predicted a good outcome, whereas treatment dropout was related to an unsatisfactory drinking outcome. A majority of the women (96%) rated the treatment experience and the treatment program favorably. The overall good results might reflect the selection of the subjects studied. CONCLUSIONS: Improving treatment program adherence would probably improve outcome for the women with an unsatisfactory drinking outcome.

Are special treatment facilities for female alcoholics needed? A controlled 2-year follow-up study from a specialized female unit (EWA) versus a mixed male/female treatment facility.

Women with alcohol problems constitute an increasing number of patients in medical service. Do they need special care? How should the treatment program be designed? The specialized female Karolinska Project for Early Treatment of Women with Alcohol Addiction (EWA) unit at the Karolinska Hospital in Stockholm, Sweden, was opened in 1981. The aim of the project is to reach women in an early stage of alcohol dependence behavior and to develop treatment programs specific to the needs of females alone. In order to investigate the value of such a specialized female unit a controlled 2-year follow-up study was carried out including 200 women. The probands were treated in the female only EWA-unit, whereas the controls were placed in the care of traditional mixed-sex alcoholism treatment centers. The 2-year follow-up study showed a more successful rehabilitation regarding alcohol consumption and social adjustment for the women treated in the specialized female unit (EWA). Improvement was noted also for the controls but to a lesser extent. Probably one of the most important achievements of a specialized female unit, such as EWA, is to attract women to come for help earlier.