ASF (a Compound of Traditional Chinese Medicine) in the treatment of patients with alcohol dependence: Study protocol of a randomized, double-blinded, placebo-controlled clinical trial.

BACKGROUND: Alcohol dependence is one of the biggest problems facing public health worldwide. Currently, it is an under-diagnosed and under-treated disease. Even when given treatments for addiction withdrawal, over 2/3 of patients who have undergone abstinence-oriented treatment will relapse in the first year. Therefore, it is necessary to find an efficacious way to prevent and treat alcohol dependence. ASF (a Compound of Traditional Chinese Medicine) has proven to inhibit the formation and expression of ethanol-induced behavioral sensitization and the development of conditioned place preference in mice. As an empirical prescription for abstinence from alcohol, ASF has long been used in clinical patients. However, the effect of ASF in humans has not yet been investigated. The purpose of this study is to evaluate the efficacy of ASF for patients with alcohol dependence. METHODS: The effect of ASF will be studied in a randomized, double-blinded, placebo-controlled clinical trial. 82 outpatients and inpatients will be recruited and randomly assigned to treatment with either ASF or placebo for 6 weeks as a complement to cognitive behavioural therapy. The primary endpoints are the changes in the average daily alcohol consumption of the 2 groups before and after treatment and comparison of the scores of the psychological craving self-rating scale during the courses of treatment of 2 groups. The secondary endpoints include abstinence rates of the 2 groups during the follow-up period, days without consumption, and changes of Short Form Health Survey (SF-36) scores in 2 groups before and after therapy. DISCUSSION: This study is the first randomized controlled trial to investigate ASF in the treatment of alcohol dependence. ASF is likely to be a new and effective drug for the treatment of alcohol dependence developed from natural products with a low incidence of side effects or toxicity. TRIAL REGISTRATION: Registry number: ChiCTR2000039397.

Laboratory test based assessment of WHO alcohol risk drinking levels.

Low-risk thresholds for alcohol use differ across various national guidelines. To assess the novel WHO risk drinking levels in light of alcohol-sensitive common laboratory tests, we analysed biomarkers of liver status, inflammation and lipid profiles from a population-based survey of individuals classified to abstainers and different WHO risk drinking levels defined in terms of mean alcohol consumption per day. The study included 22,327 participants aged 25-74 years from the National FINRISK Study. Data on alcohol use, health status, diet, body weight and lifestyle (smoking, coffee consumption and physical activity) were recorded from structured interviews. Alcohol data from self-reports covering the past 12 months were used to categorize the participants into subgroups of abstainers and WHO risk drinking categories representing low, moderate, high and very high risk drinkers. Serum liver enzymes (GGT, ALT), C-reactive protein (CRP) and lipid profiles were measured using standard laboratory techniques. Alcohol risk category was roughly linearly related with the occurrence of elevated values for GGT, ALT and CRP. Alcohol drinking also significantly influenced the incidence of abnormalities in serum lipids. Significantly higher odds for abnormal GGT, ALT and altered lipid profiles remained in alcohol drinkers even after adjustment for age, waist circumference, physical inactivity, smoking and coffee consumption. A more systematic use of laboratory tests during treatment of individuals classified to WHO risk drinking categories may improve the assessment of alcohol-related health risks. Follow-ups of biomarker responses may also prove to be useful in health interventions aimed at reducing alcohol consumption.

Gratitude, abstinence, and alcohol use disorders: Report of a preliminary finding.

Gratitude is a central component of addiction recovery for many, yet it has received scant attention in addiction research. In a sample of 67 individuals entering abstinence-based alcohol-use-disorder treatment, this study employed gratitude and abstinence variables from sequential assessments (baseline, 6months, 12months) to model theorized causal relationships: gratitude would increase pre-post treatment and gratitude after treatment would predict greater percent days abstinent 6months later. Neither hypothesis was supported. This unexpected result led to the theory that gratitude for sobriety was the construct of interest; therefore, the association between gratitude and future abstinence would be positive among those already abstinent. Thus, post-treatment abstinence was tested as a moderator of the effect of gratitude on future abstinence: this effect was statistically significant. For those who were abstinent after treatment, the relationship between gratitude and future abstinence was positive; for those drinking most frequently after treatment, the relationship between gratitude and future abstinence was negative. In this preliminary study, dispositional tendency to affirm that there is much to be thankful for appeared to perpetuate the status quo-frequent drinkers with high gratitude were drinking frequently 6months later; abstinent individuals with high gratitude were abstinent 6months later. Gratitude exercises might be contraindicated for clients who are drinking frequently and have abstinence as their treatment goal.

Randomized open-label trial of baclofen for relapse prevention in alcohol dependence.

BACKGROUND: Alcohol dependence is a progressive chronic disorder characterized by narrowing of the drinking repertoire, salience of drinking, tolerance and withdrawal phenomenon, compulsion to drink, and frequent relapses. Baclofen has been shown to promote abstinence, to reduce craving, and to reduce anxiety in alcohol-dependent individuals, and it promises to be a useful agent, although clinical data are limited at present. OBJECTIVE: The current study aimed to test the utility of baclofen, a GABA agonist, in improving the relapse rates in alcohol-dependent subjects. METHODS: A total of 122 alcohol-dependent subjects were randomized into two groups. Groups were administered baclofen (30 mg/day) or benfothiamine (a nutritional supplement) using an open label design. Both groups received brief motivational intervention. Subjects were assessed at 0, 2, 4, 8, and 12 weeks for the primary outcome measures: time to first relapse, heavy drinking days, cumulative abstinence duration, and craving (measured by the Obsessive Compulsive Drinking Scale (OCDS)). RESULTS: Seventy-two participants received baclofen, and 50 received benfothiamine. Participants receiving baclofen remained abstinent for significantly more days than the benfothiamine group (p < 0.05). The percentage of heavy drinking days was significantly lower in the baclofen group (p = 0.001). Craving and anxiety scores (Hamilton Anxiety Rating Scale) were also significantly decreased in the baclofen group relative to the control group (p = 0.001). Time to first relapse was similar in both groups. CONCLUSION: In this open-label trial, alcohol-dependent participants receiving baclofen showed significant improvements in drinking outcomes compared with participants receiving benfothiamine. This study provides further evidence that baclofen is useful for the treatment of alcohol dependence.

Predictors of maternal drinking trajectories before and after pregnancy: evidence from a longitudinal study.

BACKGROUND: Little is known about patterns of change in alcohol consumption and predictors of these patterns over the prenatal to postnatal period. AIMS: To determine trajectories of maternal alcohol consumption before and after pregnancy and predictors of these trajectories. MATERIALS AND METHODS: A total of 6597 Australian women were sampled from a longitudinal study. Group-based trajectory modelling was applied to determine drinking trajectories from prepregnancy, early pregnancy, late pregnancy and 6 months after the birth. Predictors associated with drinking trajectories were examined using multinomial logistic regression. RESULTS: Three trajectories of maternal alcohol consumption were identified: abstainers/minimal consumption (53.2%), light consumption (39.4%) and heavy consumption (7.4%). The heavy consumption group substantially reduced their consumption in pregnancy but increased their consumption once the baby was born. Some 80.0% of this group were breastfeeding their babies. The light consumption group had only minor changes in their drinking pattern. Lower family income, being married, high frequency of church attendance, low level of adversity, poor health lifestyle, remaining married to original partner and having many children predicted membership of the abstaining/minimal consumption trajectory. Being unmarried, having only one child, having unhealthy health lifestyle and never going to church predicted membership of the heavy consumption group. CONCLUSION: Women who consume higher levels of alcohol prior to their pregnancy reduce their consumption once pregnant, but tend to increase their alcohol consumption shortly after the birth. A public health campaign dealing with predictors associated with heavier alcohol consumption and safe breastfeeding targetted at these women is needed.