Efficacy of acamprosate for alcohol dependence in a family medicine setting in the United States: a randomized, double-blind, placebo-controlled study.

BACKGROUND: Acamprosate has been found to enhance rates of complete abstinence and to increase percent days abstinent (PDA) from alcohol relative to placebo treatment. As most U.S. clinical trials of acamprosate have been conducted in alcohol and other drug specialty clinics, there is a need to examine the efficacy of acamprosate in generalist settings. This study tested the efficacy of acamprosate versus placebo on the primary study outcome of PDA in the treatment of alcohol-dependent patients in a family medicine setting. Secondary study outcomes included percent heavy drinking days (%HDD) and gamma glutamyltransferase level (normal or high). METHODS: A randomized, double-blind, placebo-controlled, parallel group design of acamprosate was conducted in 2 family medicine settings (North Carolina and Wisconsin). One hundred volunteers were recruited primarily by advertisement, and participants were assigned to 666 mg (2 pills) oral acamprosate 3 times daily (1,998 mg/d) or matching placebo over a 12-week period. All participants concomitantly received 5 sessions of a brief behavioral intervention from a family/primary care physician. RESULTS: No significant treatment effect of acamprosate was found on PDA or the secondary outcomes. Significant treatment goal by time interaction effects was found on PDA and %HDD. Participants who had an initial goal of abstinence versus a reduction in alcohol use improved on average over time in PDA and had less %HDD from baseline to the end of treatment. CONCLUSIONS: This clinical trial did not find evidence of efficacy for acamprosate compared to placebo among alcohol-dependent individuals recruited primarily by advertisement as studied in a primary care setting. Drinking outcomes significantly improved regardless of medication condition. A goal of abstinence was significantly associated with improved drinking outcomes, suggesting that alcohol-dependent patients with such a goal may do particularly well with counseling in a family medicine setting.

Maximum forces acting on the abdominal wall: experimental validation of a theoretical modeling in a human cadaver study.

Incisional hernias following median laparotomy have a high incidence and recurrence rate after repair, so that a better understanding of the linea alba biomechanics is desirable. The mechanical stress exerted on the linea alba in living humans is primarily generated by the musculature. In this human cadaver study, intraabdominal pressure was simulated by insertion of a balloon that was increasingly filled to maximal pressures of 200 mbar. The related forces acting transversely on the linea alba at maximum pressure were found to be between 41.6 and 52.2N/cm (mean=45.9N/cm), which is in agreement with a recent modeling of the related forces.

The effects of extended-release naltrexone on holiday drinking in alcohol-dependent patients.

A post hoc analysis examined the effect of extended-release naltrexone (XR-NTX) treatment combined with psychosocial support on alcohol consumption during holiday and nonholiday periods in a cohort of alcohol-dependent patients who had maintained at least 4 days of continuous abstinence before receiving their first treatment. Three parameters of drinking behavior were examined: percentage of drinking days, percentage of heavy drinking days, and the number of drinks per day. Patients receiving XR-NTX 380 mg reported significantly lower median percentages of drinking days, heavy drinking days, and the number of drinks per day compared with the placebo group. Patients treated with XR-NTX 190 mg reported similar results overall. The results suggest that treatment with XR-NTX 380 mg in combination with psychosocial intervention leads to significant reductions in alcohol consumption, with some measures indicating abstinence in alcohol-dependent patients with initial abstinence during holiday periods.

Patterns of urges during early abstinence in alcohol-dependent subjects.

Urges for alcohol can lead to relapse, but some alcoholics report few urges. We hypothesized that ecological momentary assessment techniques would reveal multiple urge patterns in newly-abstinent alcoholics. Forty-eight alcohol-dependent subjects used PDAs to assess urges to drink in abstinence. Mean and standard deviation of urges were used in cluster analysis, and cluster characteristics were compared. Four clusters were defined, the largest cluster including 29 subjects with low mean urge and low variability. Clusters differed in negative affect and anger but not in abstinence rates. Four distinct urge patterns during abstinence were identified, and 60% of abstinent, alcohol-dependent subjects reported low, stable urge levels.

A multi-site dose ranging study of nalmefene in the treatment of alcohol dependence.

The opiate antagonist nalmefene has been shown in 2 single-site studies to reduce alcohol consumption and relapse drinking in alcohol-dependent individuals. This safety and preliminary multisite efficacy study evaluated 3 doses of nalmefene (5, 20, or 40 mg) in a double-blind comparison to placebo over a 12-week treatment period in 270 recently abstinent outpatient alcohol-dependent individuals. Participants concomitantly received 4 sessions of a motivational enhancement therapy (with a medication compliance component) delivered from trained counselors. Although more subjects in the active medication groups terminated the study early secondary to adverse events, the rates did not differ significantly from that of placebo. The 20-mg/d group experienced more insomnia, dizziness, and confusion, while the 5-mg group also had more dizziness and the 40-mg group had more nausea than the placebo group. Most of these symptoms were mild and improved over time. Although all subjects had a reduction in heavy drinking days, craving, gamma-glutamyl transferase, and carbohydrate-deficient transferrin concentrations over the course of the study, there was no difference between the active medication and placebo groups on these measures. The time to first heavy drinking day was also not significantly different between the placebo and the active treatment groups. This relatively small multisite trial showed that nalmefene was reasonably well tolerated in recently abstinent alcoholics. However, possibly because of variation among the sites or the comparatively small sample size, there was no evidence of superior efficacy outcomes with nalmefene treatment.

Automating standard alcohol use assessment instruments via interactive voice response technology.

BACKGROUND: Interactive voice response (IVR) technology integrates touch-tone telephones with computer-automated data processing. IVR offers a convenient, efficient method for remote collection of self-report data. METHODS: Twenty-six subjects recruited from an outpatient alcohol treatment center completed IVR and paper/pencil versions of a demographic and drinking history questionnaire, Stages of Change Readiness and Treatment Eagerness Scale, Drinker Inventory of Consequences, Obsessive-Compulsive Drinking Scale, Alcohol Dependence Scale, and two numerical rating scales of craving and desire to drink during the prior week. Administration of the instruments in both formats was repeated 1 week later. The order of administration method was counterbalanced between subjects and reversed across data collection sessions. Scale and subscale scores from both methods were correlated within sessions. Test-retest correlations were also calculated for each method. A criterion of alpha = 0.01 was used to control type I statistical error. RESULTS: Intermethod correlations within each session were significant for all of the instruments administered. Test-retest correlations for both methods were also significant, except for the numerical ratings. Scores on the Alcohol Dependence Scale obtained via IVR were significantly lower than those collected by paper/pencil. Other differences between the data collection methods or across the sessions were inconsistent. The average IVR call length was 34 min and 23 sec. Paper/pencil forms required an average of 18 min and 38 sec to complete and an additional 10 min and 17 sec for data entry. CONCLUSIONS: IVR technology provides a convenient alternative to collecting self-report measures of treatment outcomes. Both paper/pencil and IVR assessments provide highly convergent data and demonstrate good test-retest reliability. Alcohol Dependence Scale score differences between methods highlight special considerations for IVR adaptation of existing paper/pencil instruments. Benefits of IVR include procedural standardization, automatic data scoring, direct electronic storage, and remote accessibility from multiple locations.