A Randomized Controlled Study of the Efficacy of Pregabalin in the Treatment of Opiate Withdrawal Syndrome

Objective. To study the efficacy and safety of pregabalin (Lyrica) in the complex therapy of opioid withdrawal syndrome (OWS). Materials and methods. The study design was a randomized, symptom-controlled, simple, blind study with active controls. A total of 34 patients with OWS were randomized to two groups. Patients of group 1 (19 subjects) received pregabalin at a dose of up to 600 mg/day as the main substance for treating OWS, in combination with symptomatic treatment (basal and symptom-triggered). Patients of group 2 (15 subjects) received clonidine (Clofelin, up to 600 mg/day) as the main treatment agent, in combination with basal and symptom-triggered treatment. The severity of OWS, cravings for opiates, sleep disorders, anxiety, depression, and side effects were assessed daily using international validated quantified assessment scales. Results. In group 1, 15 patients (79%) completed OWS treatment, compared with seven (47%) in group 2 (p = 0.05, Fisher's exact test). There were no statistically significant differences between groups in terms of the dynamics of the severity of OWS (perhaps because of the limited number of patients). In the pregabalin-treated group, measures of the intensity of opiate cravings decreased during treatment as compared with group 2 (p = 0.05), and similar changes were seen in relation to anxiety (p = 0.05) and depression (p < 0.05); self-assessments of wellbeing increased (p < 0.05). There were no significant between-group differences in the overall incidence of side effects, though treatment tolerance was better in group 1. Conclusions. The treatment scheme including pregabalin was effective and safe and was well tolerated by patients, providing more successful completion of detoxification programs.

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