[A double blind placebo controlled randomized clinical trial of the efficacy and safety of pregabalin in induction of remission in patients with alcohol dependence]. / Dvoinoe slepoe randomizirovannoe platsebo-kontroliruemoe issledovanie éffektivnosti i bezopasnosti primeneniia pregabalina dlia stabilizatsii remissii sindroma zavisimosti ot alkogolia.

AIM: To study the efficacy of pregabalin for relapse prevention and reduction of drinking in patients with alcohol dependence. MATERIAL AND METHODS: One hundred recently detoxified out-patients with alcohol dependence were randomly assigned to one of two treatment groups. Patients of the first group (n=50; 38 men, 12 women, age 43.0±1.27) received pregabalin (150 mg once a day at night time) for 3 months, while patients of the second group (n=50; 45 men, 5 women, age 45.92±1.4) received identically looking placebo. All patients received standardized manualized weekly counseling (medical management). Drinking was measured on the weekly basis with Time Line Follow Back technique and GGT enzyme activity. Also, craving for alcohol, depression, and anxiety were measured weekly with the number of scales. RESULTS: Kaplan-Meier survival analysis demonstrated significantly higher retention in treatment and in remission in the pregabalin group (lower drop out and relapse rate) mediana (CL)-12 (10.4-13.6) weeks in the pregabalin group vs. 6 (4.5-7.5) in the placebo group, Log Rank Mantel-Cox test = 0.005). Proportion of patients, who completed treatment in the pregabalin group, was significantly higher compared to the placebo group: 50% vs. 24%. Mean duration of participation in the treatment program was also higher in the pregabalin group: 9.1±0.5 weeks vs. 7.1±0.5 in the placebo group. General linear model demonstrated the significant treatment group effect on: (1) total alcohol consumption (TAC) (mean grams of alcohol per day) with lower TAC in the pregabalin group and (2) on the number of heavy drinking days (NHDD) with lower NHDD in the pregabalin group. Mean NHDD per patient for the period of participation in the study was lower in the pregabalin group (3.6±0.7 vs. 6.4±0.8; p=0.009), while the mean number of abstinent (sober) days was higher (55.9±3.6 vs. 40.0±3.3; p=0.001). No significant differences between the two groups were found in the scores on craving for alcohol, depression and anxiety scales. GGT activity was also similar in both groups throughout the study with no significant between group differences. The rate of adverse events (sleepiness, dizziness, and headache) was insignificantly higher in the pregabalin group compared with the placebo group. All adverse events were mild, gradually disappeared, and did not require any medication. CONCLUSION: Results of this study provide evidence that pregabalin in a low dose of 150 mg per day is an effective and safe medication for relapse prevention and reduction of drinking in patients with alcohol dependence.

[A randomized single blind study of the efficacy of pregabalin in the treatment of opioid withdrawal syndrome]. / Randomizirovannoe kontroliruemoe issledovanie effektivnosti pregabalina v terapii sindroma otmeny opiatov.

AIM: To study the efficacy and safety of pregabalin (lyrica) in the complex treatment of opioid withdrawal syndrome (OWS). STUDY DESIGN: single-blind randomized symptom-triggered protocol with an active control. Thirty-four patients were randomly assigned to two groups. The first group (n=19) received up to 600 mg a day of pregabalin for six days along with symptomatic therapy (basic and symptom-triggered). The second group (n=15) received up to 600 micrograms of clonidine a day as the main treatment along with the same basic and symptomatic regimen. Opiate withdrawal severity, craving, sleep disturbance, anxiety and depression, as well as general clinical impressions and side-effects were assessed daily using internationally validated quantitative psychometric instruments. RESULTS: In the pregabalin group, 15 out of 19 (79%) patients completed treatment compared to 7 out of 15 (47%) patients in the clonidine group (p=0.05; Fisher exact test). There were no statistically significant differences between groups on any assessments of the severity of OWS (reduction of the severity of opiate withdrawal), perhaps because of the small sample size. In the pregabalin group, there were lower indicators of the severity of craving for opiates (p=0.05), anxiety (p=0.05) and depression (p<0.05), while patient-rated self-assessment of their general health condition was significantly better compared to the second group (p<0.05). There were no significant differences in the frequency of adverse events between the groups, though the better tolerability of treatment was noted in the pregabalin group. CONCLUSION: Treatment regimen of OWS with pregabalin is effective and safe and patients tolerate it better that leads to a higher detoxification completion rate (retention).