Pregabalin versus naltrexone in alcohol dependence: a randomised, double-blind, comparison trial.
Pregabalin (PRE) acts as a presynaptic inhibitor of the release of excessive levels of excitatory neurotransmitters by selectively binding to the alpha(2)-delta subunit of voltage-gated calcium channels. In this randomised, double-blind comparison trial with naltrexone (NAL), we aimed to investigate the efficacy of PRE on alcohol drinking indices. Craving reduction and improvement of psychiatric symptoms were the secondary endpoints. Seventy-one alcohol-dependent subjects were detoxified and subsequently randomised into two groups, receiving 50 mg of NAL or 150-450 mg of PRE. Craving (VAS; OCDS), withdrawal (CIWA-Ar) and psychiatric symptoms (SCL-90-R) rating scales were applied. Alcohol drinking indices and craving scores were not significantly different between groups. Compared with NAL, PRE resulted in greater improvement of specific symptoms in the areas of anxiety, hostility and psychoticism, and survival function (duration of abstinence from alcohol). PRE also resulted in better outcome in patients reporting a comorbid psychiatric disorder. Results from this study globally place PRE within the same range of efficacy as that of NAL. The mechanism involved in the efficacy of PRE in relapse prevention could be less related to alcohol craving and more associated with the treatment of the comorbid psychiatric symptomatology.
Department of Psychiatry, Catholic University Medical School, Rome, Italy. giovanni.martinotti@libero.it
G
G
Martinotti
M
M
Di Nicola
D
D
Tedeschi
S
S
Andreoli
D
D
Reina
M
M
Pomponi
M
M
Mazza
R
R
Romanelli
N
N
Moroni
R
R
De Filippis
M
M
Di Giannantonio
G
G
Pozzi
P
P
Bria
L
L
Janiri
D000328:Adult; D000430:Alcohol Withdrawal Delirium / Q000188:drug therapy; D019973:Alcohol-Related Disorders / Q000188:drug therapy*; D000927:Anticonvulsants / Q000009:adverse effects / Q000627:therapeutic use*; D001007:Anxiety / Q000188:drug therapy; D002121:Calcium Channel Blockers / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D006791:Hostility; D006801:Humans; D008297:Male; D008875:Middle Aged; D009271:Naltrexone / Q000009:adverse effects / Q000627:therapeutic use*; D009292:Narcotic Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D009771:Obsessive-Compulsive Disorder / Q000188:drug therapy*; D000069583:Pregabalin; D012720:Severity of Illness Index; D013375:Substance Withdrawal Syndrome / Q000188:drug therapy; D005680:gamma-Aminobutyric Acid / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use
D000927:Anticonvulsants; D002121:Calcium Channel Blockers; D009292:Narcotic Antagonists; D000069583:Pregabalin; D005680:gamma-Aminobutyric Acid; D009271:Naltrexone