title: [Naltrexone and fluoxetine for maintenance of remission in patients with heroin addiction: a double-blind randomized placebo-controlled trial].
abstract: Two hundreds and eighty patients with heroin addiction were randomized into 4 equal groups. Patients of the group 1 received naltrexone (N) in dosage 50 mg/day and fluoxetine (F) in dosage 20 mg/day during 6 months. Group 2 received N/F-placebo (FN), group 3--N-placebo (NP)/F and group 4--NP/FP. All patients underwent a session of individual psychotherapy for the maintenance of remission. Express urine drugs tests were used for remission control. Compliance was controlled by a riboflavin marker. Clinical state, psychiatric status and social functioning were assessed using quantified international scales and tests. To the end of the 6 month course, 43% of patients of group 1, 36% of group 2, 21% of group 3 and 10% of group 4 were in remission. Therefore, N/F was more effective than F/NP (p < 0.01) and FP/NP (p < 0.001); N/FP was more effective than F/NP (p < 0.05) and NP/FP (p < 0.001); F/NP did not differ significantly from NP/FP (p = 0.1); N/F did not differ from N/FP (p = 0.2). However N/F was more effective compared to N/FP only in women, probably, due to the higher baseline levels of depression, anxiety and anhedonia. Naltrexone was superior to placebo and fluoxetine in the efficacy of maintenance of remission and preventing relapse in patients with heroin addiction. The combination of naltrexone and fluoxetine was more effective compared to the monotherapy with naltrexone in women only.
authors.forename: E M
authors.initials: EM
authors.lastname: Krupitskiĭ
authors.forename: E E
authors.initials: EE
authors.lastname: Zvartau
authors.forename: M V
authors.initials: MV
authors.lastname: Tsoĭ-Podosenin
authors.forename: D V
authors.initials: DV
authors.lastname: Masalov
authors.forename: A M
authors.initials: AM
authors.lastname: Burakov
authors.forename: V Iu
authors.initials: VIu
authors.lastname: Egorova
authors.forename: T Iu
authors.initials: TIu
authors.lastname: Didenko
authors.forename: T N
authors.initials: TN
authors.lastname: Romanova
authors.forename: E B
authors.initials: EB
authors.lastname: Ivanova
authors.forename: A Iu
authors.initials: AIu
authors.lastname: Bespalov
authors.forename: E V
authors.initials: EV
authors.lastname: Verbitskaia
authors.forename: N G
authors.initials: NG
authors.lastname: Neznanov
authors.forename: A Ia
authors.initials: AIa
authors.lastname: Grineneko
authors.forename: C
authors.initials: C
authors.lastname: O'Brien
authors.forename: D
authors.initials: D
authors.lastname: Woody
mesh_terms: D000293:Adolescent; D000328:Adult; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005473:Fluoxetine / Q000627:therapeutic use*; D006556:Heroin Dependence / Q000188:drug therapy*; D006801:Humans; D008297:Male; D009271:Naltrexone / Q000627:therapeutic use*; D009292:Narcotic Antagonists / Q000627:therapeutic use*; D010919:Placebos; D012074:Remission Induction; D017367:Selective Serotonin Reuptake Inhibitors / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D005473:Fluoxetine; D009271:Naltrexone; D009292:Narcotic Antagonists; D010919:Placebos; D017367:Selective Serotonin Reuptake Inhibitors