Historique
Article de Périodique
Injectable extended-release naltrexone for opioid dependence: a double-blind, placebo-controlled, multicentre randomised trial (2011)
Auteur(s) :
KRUPITSKY, E. M. ;
NUNES, E. V. ;
LING, W. ;
ILLEPERUMA, A. ;
GASTFRIEND, D. R. ;
SILVERMAN, B. L.
Année :
2011
Page(s) :
1506-1513
Langue(s) :
Anglais
Refs biblio. :
35
Domaine :
Autres substances / Other substances
Thésaurus géographique
RUSSIE
Thésaurus mots-clés
OPIOIDES
;
NALTREXONE
;
ETUDE RANDOMISEE
;
DEPENDANCE
;
TRAITEMENT DE MAINTENANCE
;
RETENTION
;
PHARMACOTHERAPIE
Note générale :
• Comment: "Concerns about injectable naltrexone for opioid dependence", Wolfe D., Carrieri M.P., Dasgupta N., Wodak A., Newman R., Bruce R.D., p. 1468-1470.
• Correspondences: "Promise of extended-release naltrexone is a red herring" & Authors' reply, The Lancet, 378(9792, p. 663-664. "Injectable extended-release naltrexone for opioid dependence" & Authors' reply, p. 664-666.
• Analysé dans la revue de presse de la Revue du Praticien 2011;(61)6, p. 764.
• Correspondences: "Promise of extended-release naltrexone is a red herring" & Authors' reply, The Lancet, 378(9792, p. 663-664. "Injectable extended-release naltrexone for opioid dependence" & Authors' reply, p. 664-666.
• Analysé dans la revue de presse de la Revue du Praticien 2011;(61)6, p. 764.
Résumé :
BACKGROUND Opioid dependence is associated with low rates of treatment-seeking, poor adherence to treatment, frequent relapse, and major societal consequences. We aimed to assess the efficacy, safety, and patient-reported outcomes of an injectable, once monthly extended-release formulation of the opioid antagonist naltrexone (XR-NTX) for treatment of patients with opioid dependence after detoxification.
METHODS We did a double-blind, placebo-controlled, randomised, 24-week trial of patients with opioid dependence disorder. Patients aged 18 years or over who had 30 days or less of inpatient detoxification and 7 days or more off all opioids were enrolled at 13 clinical sites in Russia. We randomly assigned patients (1:1) to either 380 mg XR-NTX or placebo by an interactive voice response system, stratified by site and gender in a centralised, permuted-block method. Participants also received 12 biweekly counselling sessions. Participants, investigators, staff, and the sponsor were masked to treatment allocation. The primary endpoint was the response profile for confirmed abstinence during weeks 5-24, assessed by urine drug tests and self report of non-use. Secondary endpoints were self-reported opioid-free days, opioid craving scores, number of days of retention, and relapse to physiological opioid dependence. Analyses were by intention to treat. This trial is registered at ClinicalTrials.gov, NCT00678418.
FINDINGS Between July 3, 2008, and Oct 5, 2009, 250 patients were randomly assigned to XR-NTX (n=126) or placebo (n=124). The median proportion of weeks of confirmed abstinence was 90.0% (95% CI 69.9-92.4) in the XR-NTX group compared with 35.0% (11.4-63.8) in the placebo group (p=0.0002). Patients in the XR-NTX group self-reported a median of 99.2% (range 89.1-99.4) opioid-free days compared with 60.4% (46.2-94.0) for the placebo group (p=0.0004). The mean change in craving was -10.1 (95% CI -12.3 to -7.8) in the XR-NTX group compared with 0.7 (-3.1 to 4.4) in the placebo group (p INTERPRETATION XR-NTX represents a new treatment option that is distinct from opioid agonist maintenance treatment. XR-NTX in conjunction with psychosocial treatment might improve acceptance of opioid dependence pharmacotherapy and provide a useful treatment option for many patients.
METHODS We did a double-blind, placebo-controlled, randomised, 24-week trial of patients with opioid dependence disorder. Patients aged 18 years or over who had 30 days or less of inpatient detoxification and 7 days or more off all opioids were enrolled at 13 clinical sites in Russia. We randomly assigned patients (1:1) to either 380 mg XR-NTX or placebo by an interactive voice response system, stratified by site and gender in a centralised, permuted-block method. Participants also received 12 biweekly counselling sessions. Participants, investigators, staff, and the sponsor were masked to treatment allocation. The primary endpoint was the response profile for confirmed abstinence during weeks 5-24, assessed by urine drug tests and self report of non-use. Secondary endpoints were self-reported opioid-free days, opioid craving scores, number of days of retention, and relapse to physiological opioid dependence. Analyses were by intention to treat. This trial is registered at ClinicalTrials.gov, NCT00678418.
FINDINGS Between July 3, 2008, and Oct 5, 2009, 250 patients were randomly assigned to XR-NTX (n=126) or placebo (n=124). The median proportion of weeks of confirmed abstinence was 90.0% (95% CI 69.9-92.4) in the XR-NTX group compared with 35.0% (11.4-63.8) in the placebo group (p=0.0002). Patients in the XR-NTX group self-reported a median of 99.2% (range 89.1-99.4) opioid-free days compared with 60.4% (46.2-94.0) for the placebo group (p=0.0004). The mean change in craving was -10.1 (95% CI -12.3 to -7.8) in the XR-NTX group compared with 0.7 (-3.1 to 4.4) in the placebo group (p INTERPRETATION XR-NTX represents a new treatment option that is distinct from opioid agonist maintenance treatment. XR-NTX in conjunction with psychosocial treatment might improve acceptance of opioid dependence pharmacotherapy and provide a useful treatment option for many patients.
Affiliation :
Department of Addictions, St Petersburg Bekhterev Psychoneurological Research Institute, Bekhtereva Street 3, St Petersburg 192019, Russia / Russie