Dataset Information

Effect of γ-hydroxybutyrate (GHB) on driving as measured by a driving simulator.

ABSTRACT:

Rationale

Gamma-hydroxybutyrate acid (GHB), a GABA_B receptor agonist approved for treatment of narcolepsy, impairs driving ability, but little is known about doses and plasma concentrations associated with impairment and time course of recovery.

Objective

To assess effects of oral GHB (Xyrem®) upon driving as measured by a driving simulator, and to determine plasma concentrations associated with impairment and the time course of recovery.

Methods

Randomized, double-blind, two-arm crossover study, during which 16 participants received GHB 50 mg/kg orally or placebo. GHB blood samples were collected prior to and at 1, 3, and 6 h post dosing. Driving simulator sessions occurred immediately after blood sampling.

Results

Plasma GHB was not detectable at baseline or 6 h post dosing. Median GHB concentrations at 1 and 3 h were 83.1 mg/L (range 54-110) and 24.4 mg/L (range 7.2-49.7), respectively. Compared to placebo, at 1 h post GHB dosing, significant differences were seen for the life-threatening outcome collisions (p < 0.001) and off-road accidents (p = 0.018). Although driving was not faster, there was significantly more weaving and erratic driving with GHB as measured by speed deviation (p = 0.002) and lane position deviation (p = 0.004). No significant impairment regarding driving outcomes was found in the GHB group at 3 and 6 h post dose.

Conclusion

GHB in doses used to treat narcolepsy resulted in severe driving impairment at 1 h post dosing. After 3 to 6 h, there was full recovery indicating that safe driving is expected the next morning after bedtime therapeutic GHB use in the absence of other substances.

SUBMITTER: Liakoni E

PROVIDER: S-EPMC6457903 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature

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Publications

Effect of γ-hydroxybutyrate (GHB) on driving as measured by a driving simulator.

Liakoni Evangelia E Dempsey Delia A DA Meyers Matthew M Murphy Nancy G NG Fiorentino Dary D Havel Christopher C Haller Christine C Benowitz Neal L NL

Psychopharmacology 20180919 11

<h4>Rationale</h4>Gamma-hydroxybutyrate acid (GHB), a GABA<sub>B</sub> receptor agonist approved for treatment of narcolepsy, impairs driving ability, but little is known about doses and plasma concentrations associated with impairment and time course of recovery.<h4>Objective</h4>To assess effects of oral GHB (Xyrem®) upon driving as measured by a driving simulator, and to determine plasma concentrations associated with impairment and the time course of recovery.<h4>Methods</h4>Randomized, doub ...[more]

PMID: 30232528

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Project description:BackgroundGamma-hydroxybutyrate (GHB) dependence is associated with a severe, potentially lethal, withdrawal syndrome and relapse rates as high as 60% within 3 months of detoxification. Baclofen has been shown to decrease self-administration of GHB in mice and reduce relapse in a case series of GHB-dependent patients. Controlled studies on the effectiveness of baclofen to prevent relapse in GHB-dependent patients are lacking.AimThe aim of this study was to assess effectiveness of baclofen in preventing relapse in GHB-dependent patients.MethodsThis was an out-patient, multicentre, open-label, non-randomized, controlled trial in GHB-dependent patients (n = 107) in the Netherlands. Treatment as usual (TAU, n = 70) was compared with TAU plus baclofen 45-60 mg/day for 3 months (n = 37). Outcome measures were rates of lapse (any use) and relapse (using GHB on average once a week or more), based on self-report. Side effects were monitored with a baclofen side-effects questionnaire. Treatment groups were compared using Chi square analyses, with both per-protocol (PP) and intention-to-treat (ITT) analyses.ResultsGHB-dependent patients treated with baclofen after detoxification showed no reduced lapse rates, but reduced relapse and dropout rates, compared with patients receiving TAU only (24 vs 50%). While both ITT and PP analyses revealed similar results, the effectiveness of baclofen prescribed PP was slightly higher than in ITT analysis. Patients reported overall limited side effects, with the most frequently reported being feeling tired (28%), sleepiness (14%) and feeling depressed (14%). No serious adverse events were reported.ConclusionsThis study showed potential effectiveness of baclofen in preventing relapse in patients with GHB dependence after detoxification. Though promising, future studies with longer follow-up and a randomized double-blind design should confirm these findings before recommendations for clinical practice can be made.Clinical trial registrationNetherlands Trial Register with number NTR4528.

Project description:Objectives: Attention Restoration Theory (ART) suggests that walking or being in natural settings, as opposed to urban environments, benefits cognitive skills because it is less demanding on attentional resources. However, it is unclear whether the same occurs when the person is performing a complex task such as driving, although it is proven that driving through different road environments is associated with different levels of fatigue and may engage attention differently. The present study investigated whether exposure to rural vs. urban road environments while driving would affect attentional capacity in young people after the drive, in line with the classic ART paradigms. Methods: We asked 38 young participants to complete the Sustained Attention to Response Task (SART) before and after being exposed to a rural or urban road in a virtual reality environment while driving in a full vehicle immersive driving simulator. Changes in SART performance based on environmental exposure where explored in terms of target sensitivity, accuracy, reaction times, and inverse efficiency. We analyzed potential road type effects on driving speed and accuracy. Possible effects of driving on attention were tested by comparing the sample performance to that of a control group of 15 participants who did not drive and sat on the passenger seat instead. Results: Exposure to rural or urban road environments in the driving sample was not associated with any significant changes in attentional performance. The two exposure groups did not differ significantly in terms of driving behavior. Comparisons between the driving sample and the control group controlling for age indicated that participants who drove were more accurate but slower at the SART than those who were passengers. Conclusion: The present study does not support the hypothesis that a short drive in a natural setting may promote attention restoration as compared to an urban setting. Methodological considerations as well as recommendations for future research are discussed.

Dataset Information

Effect of γ-hydroxybutyrate (GHB) on driving as measured by a driving simulator.

Rationale

Objective

Methods

Results

Conclusion

Publications

Effect of γ-hydroxybutyrate (GHB) on driving as measured by a driving simulator.

Similar Datasets

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