Naltrexone with or without fluoxetine for preventing relapse to heroin addiction in St. Petersburg, Russia.
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.
Krupitsky
Evgeny M
EM
St. Petersburg Scientific-Research Center of Addictions and Psychopharmacology, St. Petersburg, Russia.
Zvartau
Edwin E
EE
Masalov
Dimitry V
DV
Tsoy
Marina V
MV
Burakov
Andrey M
AM
Egorova
Valentina Y
VY
Didenko
Tatyana Y
TY
Romanova
Tatyana N
TN
Ivanova
Eva B
EB
Bespalov
Anton Y
AY
Verbitskaya
Elena V
EV
Neznanov
Nikolai G
NG
Grinenko
Alexandr Y
AY
O'Brien
Charles P
CP
Woody
George E
GE
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*
D018687:Antidepressive Agents, Second-Generation; D009292:Narcotic Antagonists; D005473:Fluoxetine; D009271:Naltrexone; D003932:Heroin