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Fluoxetine versus N-acetylcysteine in reducing craving in Indian men with alcohol dependence syndrome: a randomised controlled trial.

  • 2025-12-31
  • East Asian archives of psychiatry : official journal of the Hong Kong College of Psychiatrists = Dong Ya jing shen ke xue zhi : Xianggang jing shen ke yi xue yuan qi kan 35(4)
    • T Shruthi
    • L Govindan
    • S S Kanagarajan

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 100
Population
Men with alcohol dependence syndrome (ADS) aged 18 to 65 years who had maintained ≥7 days of abstinence
Methods
Randomised in a 1:1 ratio to receive either oral fluoxetine 20 mg/day or NAC 600 mg twice/day for 12 weeks, with follow-up at weeks 4, 8, and 12
Blinding
Open-label
Duration
12 weeks
Funding
Unclear
  • Large Human Trial

Objectives

To compare the efficacy of fluoxetine and N-acetylcysteine (NAC) in reducing craving, relapse, and improving treatment adherence in men with alcohol dependence syndrome (ADS).

Methods

Men aged 18 to 65 years with a diagnosis of ADS who had maintained ≥7 days of abstinence from alcohol were recruited. Participants were randomised in a 1:1 ratio to receive either oral fluoxetine 20 mg/day or NAC 600 mg twice/day for 12 weeks. Participants were followed up at weeks 4, 8, and 12. Outcome measures included the Penn Alcohol Craving Scale (PACS), relapse rate, treatment adherence, and adverse effects.

Results

In total, 100 men were equally randomised to receive either fluoxetine or NAC. Both fluoxetine and NAC were effective in lowering PACS scores over 12 weeks, with scores being lower in the NAC group than in the fluoxetine group at week 4 (15.4 vs 17.6, p = 0.03), week 8 (11.3 vs 14.2, p = 0.002), and week 12 (7.8 vs 11.1, p < 0.001). The reduction in PACS scores was significantly greater in the NAC group from week 4 onward. Relapse rates were lower in the NAC group (18.0% vs 32.0%, p = 0.049). Treatment adherence was higher (but not significantly) in the NAC group (90.0% vs 84.0%, p = 0.38). Both medications were well tolerated. All adverse effects were mild.

Conclusion

Both fluoxetine and NAC were effective in reducing alcohol craving over 12 weeks, with greater reduction in the NAC group at each follow-up assessment. The NAC group also had a lower relapse rate and better adherence and tolerability.

Research Insights

  • N-Acetyl Cysteine→Improved Treatment Adherence

    Treatment adherence was higher (but not significantly) in the NAC group (90.0% vs 84.0%, p = 0.38).

    Effect
    Neutral
    Effect size
    Small
    Dose
    600 mg twice/day
  • N-Acetyl Cysteine→Reduced Alcohol Craving

    Both fluoxetine and NAC were effective in lowering PACS scores over 12 weeks, with scores being lower in the NAC group than in the fluoxetine group at week 4 (15.4 vs 17.6, p = 0.03), week 8 (11.3 vs 14.2, p = 0.002), and week 12 (7.8 vs 11.1, p < 0.001).

    Effect
    Beneficial
    Effect size
    Large
    Dose
    600 mg twice/day
  • N-Acetyl Cysteine→Reduced Relapse Rate

    Relapse rates were lower in the NAC group (18.0% vs 32.0%, p = 0.049).

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    600 mg twice/day

Adverse Events Reported

  • N-Acetyl Cysteine→Overall tolerability

    Both medications were well tolerated. All adverse effects were mild.

    Finding
    Reported
    Grade
    mild
  • N-Acetyl Cysteine→adverse effects

    All adverse effects were mild.

    Finding
    Reported
    Grade
    mild
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