Baclofen to Prevent Relapse in Gamma-Hydroxybutyrate (GHB)-Dependent Patients: A Multicentre, Open-Label,...

Area of Science:

• Neuroscience
• Pharmacology
• Addiction Medicine

Background:

• Gamma-hydroxybutyrate (GHB) dependence presents a severe withdrawal syndrome and high relapse rates post-detoxification.
• Baclofen has demonstrated efficacy in reducing GHB self-administration in animal models and relapse in case studies.
• Controlled studies are lacking to validate baclofen's effectiveness in preventing relapse in GHB-dependent individuals.

Purpose of the Study:

• To evaluate the effectiveness of baclofen in preventing relapse among patients dependent on Gamma-hydroxybutyrate (GHB).

Main Methods:

• An open-label, non-randomized, controlled trial involving 107 GHB-dependent outpatients in the Netherlands.
• Comparison of Treatment as Usual (TAU) with TAU plus baclofen (45-60 mg/day for 3 months).
• Outcome measures included lapse and relapse rates via self-report, with side effect monitoring and Chi square analyses for PP and ITT populations.

Main Results:

• Baclofen treatment did not reduce lapse rates but significantly decreased relapse and dropout rates compared to TAU alone (24% vs 50%).
• Both intention-to-treat (ITT) and per-protocol (PP) analyses showed similar effectiveness, with slightly higher efficacy in the PP group.
• Reported side effects were generally mild, including fatigue, sleepiness, and depression; no serious adverse events occurred.

Conclusions:

• Baclofen demonstrates potential effectiveness in preventing relapse in GHB-dependent patients post-detoxification.
• Further randomized, double-blind studies with extended follow-up are recommended to confirm these promising findings.
• Clinical practice recommendations await confirmation from more rigorous research designs.