title: Naltrexone with or without fluoxetine for preventing relapse to heroin addiction in St. Petersburg, Russia.
abstract: This randomized placebo-controlled trial tested the efficacy of oral naltrexone with or without fluoxetine for preventing relapse to heroin addiction and for reducing HIV risk, psychiatric symptoms, and outcome. All patients received drug counseling with parental or significant-other involvement to encourage adherence. Patients totaling 414 were approached, 343 gave informed consent, and 280 were randomized (mean age, 23.6 +/- 0.4 years). At 6 months, two to three times as many naltrexone patients as naltrexone placebo patients remained in treatment and had not relapsed, odds ratio (OR) = 3.5 (1.96-6.12), p < .0001. Overall, adding fluoxetine did not improve outcomes, OR = 1.35 (0.68-2.66), p = .49; however, women receiving naltrexone and fluoxetine showed a trend toward a statistically significant advantage when compared to women receiving naltrexone and fluoxetine placebo, OR = 2.4 (0.88-6.59), p = .08. HIV risk, psychiatric symptoms, and overall adjustment were markedly improved among all patients who remained on treatment and did not relapse, regardless of group assignment. More widespread use of naltrexone could be an important addition to addiction treatment and HIV prevention in Russia.
authors.affiliation: St. Petersburg Scientific-Research Center of Addictions and Psychopharmacology, St. Petersburg, Russia.
authors.forename: Evgeny M
authors.initials: EM
authors.lastname: Krupitsky
authors.forename: Edwin E
authors.initials: EE
authors.lastname: Zvartau
authors.forename: Dimitry V
authors.initials: DV
authors.lastname: Masalov
authors.forename: Marina V
authors.initials: MV
authors.lastname: Tsoy
authors.forename: Andrey M
authors.initials: AM
authors.lastname: Burakov
authors.forename: Valentina Y
authors.initials: VY
authors.lastname: Egorova
authors.forename: Tatyana Y
authors.initials: TY
authors.lastname: Didenko
authors.forename: Tatyana N
authors.initials: TN
authors.lastname: Romanova
authors.forename: Eva B
authors.initials: EB
authors.lastname: Ivanova
authors.forename: Anton Y
authors.initials: AY
authors.lastname: Bespalov
authors.forename: Elena V
authors.initials: EV
authors.lastname: Verbitskaya
authors.forename: Nikolai G
authors.initials: NG
authors.lastname: Neznanov
authors.forename: Alexandr Y
authors.initials: AY
authors.lastname: Grinenko
authors.forename: Charles P
authors.initials: CP
authors.lastname: O'Brien
authors.forename: George E
authors.initials: GE
authors.lastname: Woody
mesh_terms: D000328:Adult; D018687:Antidepressive Agents, Second-Generation / Q000009:adverse effects / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005473:Fluoxetine / Q000009:adverse effects / Q000627:therapeutic use*; D015658:HIV Infections / Q000517:prevention & control; D003932:Heroin / Q000009:adverse effects*; D006556:Heroin Dependence / Q000534:rehabilitation*; D006801:Humans; D008297:Male; D009271:Naltrexone / Q000009:adverse effects / Q000627:therapeutic use*; D009292:Narcotic Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D011613:Psychotherapy; D012426:Russia; D055502:Secondary Prevention; D015819:Substance Abuse, Intravenous / Q000534:rehabilitation*; D013375:Substance Withdrawal Syndrome / Q000175:diagnosis / Q000534:rehabilitation*
chemical_list: D018687:Antidepressive Agents, Second-Generation; D009292:Narcotic Antagonists; D005473:Fluoxetine; D009271:Naltrexone; D003932:Heroin