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Related Experiment Video

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Improving GHB withdrawal with baclofen: study protocol for a feasibility study for a randomised controlled trial.

Anne Lingford-Hughes1,2, Yash Patel3, Owen Bowden-Jones3

  • 1Central North West London NHS Foundation Trust's Club Drug Clinic, 69 Warwick Rd, London, SW5 9HB, UK. anne.lingford-hughes@imperial.ac.uk.

Trials
|September 29, 2016
PubMed
Summary

This study explored baclofen as a treatment for gamma-hydroxybutyrate (GHB) withdrawal. Results will inform a larger trial on baclofen

Keywords:
BaclofenBenzodiazepineGABABGBLGHBGHB/GBL dependenceGHB/GBL withdrawalGamma-butyrolactoneGamma-hydroxybutyrate

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Area of Science:

  • Addiction Medicine
  • Pharmacology
  • Clinical Trials

Background:

  • Gamma-hydroxybutyrate (GHB), gamma-butyrolactone (GBL), and 1,4-butanediol (1,4-BD) are CNS depressants with recreational use.
  • GHB/GBL dependence can cause severe withdrawal, often managed with benzodiazepines, which may not prevent all complications.
  • Baclofen, a GABAB agonist, shows promise in reducing GHB/GBL withdrawal severity.

Purpose of the Study:

  • To provide feasibility data on recruitment and outcome measures for a definitive randomized controlled trial.
  • To assess the role of baclofen as an adjunct to benzodiazepines in managing GHB/GBL withdrawal.
  • To investigate if a 2-day baclofen preload improves GHB/GBL withdrawal outcomes.

Main Methods:

  • Prospective, randomized, double-blind, placebo-controlled feasibility study.
  • Recruitment of 88 participants (inpatients and outpatients) undergoing GHB/GBL detoxification.
  • Comparison of baclofen (10 mg TID) versus placebo as an adjunct to benzodiazepines, with a 2-day preload arm for outpatients.

Main Results:

  • Data collection focused on recruitment rates, withdrawal symptom severity, sleep, mood, and GHB/GBL use.
  • Descriptive analyses will characterize the impact of baclofen on withdrawal measures and outcomes.
  • Qualitative data will assess participant and clinician acceptability and inform cost-effectiveness.

Conclusions:

  • This feasibility study provides essential data to design a definitive randomized controlled trial.
  • The trial will establish the efficacy of baclofen in reducing GHB/GBL withdrawal severity and complications.
  • Findings will guide treatment strategies for GHB/GBL dependence.