ContextAlcohol dependence treatment may include medications, behavioral therapies, or both. It is unknown how combining these treatments may impact their effectiveness, especially in the context of primary care and other nonspecialty settings.ObjectivesTo evaluate the efficacy of medication, behavioral therapies, and their combinations for treatment of alcohol dependence and to evaluate placebo effect on overall outcome.Design, Setting, and ParticipantsRandomized controlled trial conducted January 2001-January 2004 among 1383 recently alcohol-abstinent volunteers (median age, 44 years) from 11 US academic sites with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, diagnoses of primary alcohol dependence.InterventionsEight groups of patients received medical management with 16 weeks of naltrexone (100 mg/d) or acamprosate (3 g/d), both, and/or both placebos, with or without a combined behavioral intervention (CBI). A ninth group received CBI only (no pills). Patients were also evaluated for up to 1 year after treatment.Main Outcome MeasuresPercent days abstinent from alcohol and time to first heavy drinking day.ResultsAll groups showed substantial reduction in drinking. During treatment, patients receiving naltrexone plus medical management (n = 302), CBI plus medical management and placebos (n = 305), or both naltrexone and CBI plus medical management (n = 309) had higher percent days abstinent (80.6, 79.2, and 77.1, respectively) than the 75.1 in those receiving placebos and medical management only (n = 305), a significant naltrexone × behavioral intervention interaction (P = .009). Naltrexone also reduced risk of a heavy drinking day (hazard ratio, 0.72; 97.5% CI, 0.53-0.98; P = .02) over time, most evident in those receiving medical management but not CBI. Acamprosate showed no significant effect on drinking vs placebo, either by itself or with any combination of naltrexone, CBI, or both. During treatment, those receiving CBI without pills or medical management (n = 157) had lower percent days abstinent (66.6) than those receiving placebo plus medical management alone (n = 153) or placebo plus medical management and CBI (n = 156) (73.8 and 79.8, respectively; P<.001). One year after treatment, these between-group effects were similar but no longer significant.ConclusionsPatients receiving medical management with naltrexone, CBI, or both fared better on drinking outcomes, whereas acamprosate showed no evidence of efficacy, with or without CBI. No combination produced better efficacy than naltrexone or CBI alone in the presence of medical management. Placebo pills and meeting with a health care professional had a positive effect above that of CBI during treatment. Naltrexone with medical management could be delivered in health care settings, thus serving alcohol-dependent patients who might otherwise not receive treatment.Trial Registrationclinicaltrials.gov Identifier: NCT00006206

/pdf/combined-pharmacotherapies-and-behavioral-interventions-for-2vogia99j0.pdf

Combined Pharmacotherapies and Behavioral Interventions for Alcohol Dependence: The COMBINE Study: A Randomized Controlled Trial

Background: The Alcohol Use Disorders Identification Test Consumption (AUDIT-C) questions have been previously validated as a 3-item screen for alcohol misuse and implemented nationwide in Veterans Affairs (VA) outpatient clinics. However, the AUDIT-C's validity and optimal screening threshold(s) in other clinical populations are unknown.

Methods: This cross-sectional validation study compared screening questionnaires with standardized interviews in 392 male and 927 female adult outpatients at an academic family practice clinic from 1993 to 1994. The AUDIT-C, full AUDIT, self-reported risky drinking, AUDIT question #3, and an augmented CAGE questionnaire were compared with an interview primary reference standard of alcohol misuse, defined as a Diagnostic and Statistical Manual, 4th ed. alcohol use disorder and/or drinking above recommended limits in the past year.

Results: Based on interviews with 92% of eligible patients, 128 (33%) men and 177 (19%) women met the criteria for alcohol misuse. Areas under the receiver operating characteristic curves (AUROCs) for the AUDIT-C were 0.94 (0.91, 0.96) and 0.90 (0.87, 0.93) in men and women, respectively (p=0.04). Based on AUROC curves, the AUDIT-C performed as well as the full AUDIT and significantly better than self-reported risky drinking, AUDIT question #3, or the augmented CAGE questionnaire (p-values <0.001). The AUDIT-C screening thresholds that simultaneously maximized sensitivity and specificity were ≥4 in men (sensitivity 0.86, specificity 0.89) and ≥3 in women (sensitivity 0.73, specificity 0.91).

Conclusions: The AUDIT-C was an effective screening test for alcohol misuse in this primary care sample. Optimal screening thresholds for alcohol misuse among men (≥4) and women (≥3) were the same as in previously published VA studies.

AUDIT-C as a Brief Screen for Alcohol Misuse in Primary Care

Background Primary care physicians need a brief alcohol questionnaire that identifies hazardous drinking and alcohol use disorders. The Alcohol Use Disorders Identification Test (AUDIT) questions 1 through 3 (AUDIT-C), and AUDIT question 3 alone are effective alcohol-screening tests in male Veterans Affairs (VA) patients, but have not been validated in women. Methods Female VA patients (n = 393) completed self-administered questionnaires, including the 10-item AUDIT and a previously proposed modification to AUDIT question 3 with a sex-specific threshold for binge drinking (≥4 drinks/occasion), and in-person interviews with the Alcohol Use Disorder and Associated Disabilities Interview Schedule. The AUDIT-C, AUDIT question 3 alone, and the 10-item AUDIT were each evaluated with and without the sex-specific binge question and compared with past-year hazardous drinking (>7 drinks/week or ≥4 drinks/occasion) and/or active Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition alcohol abuse or dependence, based on interviews. Results Eighty-nine women (22.6%) met interview criteria for past-year hazardous drinking and/or active alcohol abuse or dependence. Standard and sex-specific AUDIT-Cs were sensitive (0.81 and 0.84, respectively) and specific (0.86 and 0.85, respectively). Their areas under the receiver operating characteristic curves were equivalent (0.91, and 0.92, respectively) and slightly higher than for the standard 10-item AUDIT (0.87). A single, sex-specific question about binge drinking (modified AUDIT question 3) had a sensitivity of 0.69 and specificity of 0.94, whereas the standard AUDIT question 3 was specific (0.96) but relatively insensitive (0.45). Conclusions The standard and sex-specific AUDIT-Cs are effective screening tests for past-year hazardous drinking and/or active alcohol abuse or dependence in female patients in a VA study.

https://jamanetwork.com/journals/jamainternalmedicine/articlepdf/215347/ioi20230.pdf

Two Brief Alcohol-Screening Tests From the Alcohol Use Disorders Identification Test (AUDIT): Validation in a Female Veterans Affairs Patient Population

men who drink more than 4 standard drinks in a day (or more than 14 per week) and women who drink more than 3 in a day (or more than 7 per week) are at increased risk for alcohol-related problems.

Helping Patients Who Drink Too Much

https://aasldpubs.onlinelibrary.wiley.com/doi/pdf/10.1002/hep.30866

Diagnosis and Treatment of Alcohol-Associated Liver Diseases: 2019 Practice Guidance From the American Association for the Study of Liver Diseases

Background Medically ill alcoholics often do not respond to conventional alcoholism treatment or decline physician referrals. Integrated outpatient treatment (IOT), a new treatment specifically designed for this population, combines comprehensive medical care with alcoholism interventions. Objective To compare the efficacy of IOT with that of standard treatment approaches. Methods One hundred five male veterans with severe medical complications caused by alcoholism and recent drinking were randomly assigned to receive IOT or referral to standard alcoholism and medical treatment and were evaluated over 2 years. Integrated outpatient treatment patients received medical care and alcoholism interventions once or twice monthly. Patients in the control group were referred for alcoholism treatment, but few accepted. However, patients in the control group did engage in outpatient medical care. Results At baseline, the mean±SD age of the control group was 57.2±10.0 years, compared with 52.8±11.5 years in the IOT group ( P =.04). The groups were well matched in other respects. The mean±SD number of visits over 2 years for the IOT patients was 42.2±29.1, compared with 17.4±15.6 for the control patients ( P P =.02). Nearly twice as many control patients (30% [n=16]) as IOT patients (18% [n=9]) died, but the results of Cox survival analysis were not significant. There were no differences in symptoms of alcohol dependence, quality of life, or life problems. The incremental cost of IOT was approximately $1100 per patient per year. Conclusions Standard medical care alone was surprisingly effective in inducing abstinence in surviving medically ill alcoholics. Integrated outpatient treatment significantly increased both engagement and abstinence for a modest annual cost. Further refinement and testing of IOT is indicated.

/pdf/a-randomized-trial-of-integrated-outpatient-treatment-for-2x8g6q2s41.pdf

Douglas H. Olson

Papers

A Randomized Trial of Integrated Outpatient Treatment for Medically Ill Alcoholic Men