Illicit gamma-hydroxybutyrate (GHB) and pharmaceutical sodium oxybate (Xyrem): differences in characteristics and misuse.

There are distinct differences in the accessibility, purity, dosing, and misuse associated with illicit gamma-hydroxybutyrate (GHB) compared to pharmaceutical sodium oxybate. Gamma-hydroxybutyrate sodium and sodium oxybate are the chemical and drug names, respectively, for the pharmaceutical product Xyrem (sodium oxybate) oral solution. However, the acronym GHB is also used to refer to illicit formulations that are used for non-medical purposes. This review highlights important differences between illicit GHB and sodium oxybate with regard to their relative abuse liability, which includes the likelihood and consequences of abuse. Data are summarized from the scientific literature; from national surveillance systems in the U.S., Europe, and Australia (for illicit GHB); and from clinical trials and post-marketing surveillance with sodium oxybate (Xyrem). In the U.S., the prevalence of illicit GHB use, abuse, intoxication, and overdose has declined from 2000, the year that GHB was scheduled, to the present and is lower than that of most other licit and illicit drugs. Abuse and misuse of the pharmaceutical product, sodium oxybate, has been rare over the 5 years since its introduction to the market, which is likely due in part to the risk management program associated with this product. Differences in the accessibility, purity, dosing, and misuse of illicit GHB and sodium oxybate suggest that risks associated with illicit GHB are greater than those associated with the pharmaceutical product sodium oxybate.

Real-world efficacy of prescription and over-the-counter nicotine replacement therapy.

AIMS: To assess smoking cessation rates achieved with nicotine gum and patch in simulated over-the-counter (OTC) and actual prescription (Rx) settings. DESIGN: Separate open-label studies with gum and patch in OTC and Rx settings. PARTICIPANTS: There were multiple samples: OTC gum: 2981 smokers; OTC patch: 2367; Rx gum: 324; Rx patch: 669. INTERVENTIONS: All smokers received active nicotine replacement. In the OTC setting, smokers self-selected doses of nicotine gum (2 or 4 mg Nicorette) or patch (21, 14 or 7 mg NicoDerm CQ). No intervention was provided. In the Rx setting, smokers were prescribed gum or patch by their physician. MEASUREMENTS: Biochemically verified continuous smoking abstinence was assessed at 6 weeks (28-day abstinence) and 6 months. FINDINGS: OTC success rates were consistently higher than Rx rates: differences were significant at 6 weeks for both patch [OR = 1.45 (1.05-1.98)] and gum [OR 2.92 (1.58-5.40)], and remained significant at 6 months for patch [OR = 3.63: (1.74-7.61)] but not gum [OR = 1.37: (0.73-2.58)]. Among OTC gum users. 16.1% were abstinent at 6 weeks and 8.4% at 6 months. For Rx gum users, abstinence rates were 7.7% at 6 weeks and 7.7% at 6 months. With OTC patch, 19.0% were abstinent at 6 weeks and 9.2% at 6 months. With Rx patch. abstinence rates were 16.0% at 6 weeks and 3.0% at 6 months. CONCLUSIONS: Smoking cessation rates achieved with nicotine gum and patch under OTC conditions were as good as those under real-world prescribing conditions.

Efficacy of over-the-counter nicotine patch.

This study aimed to assess the efficacy of the nicotine patch for smoking cessation, under simulated conditions of over-the-counter sale, absent any direct instruction or behavioral treatment. In a randomized, double-blind, placebo-controlled, multicenter study, 567 smokers were randomized to an active nicotine patch (n = 283) or placebo (n = 284). Treatment followed a three-step program of 21 mg/day for 6 weeks, 14 mg/day for 2 weeks and 7 mg/day for 2 weeks. Participants received brief written instructions, an audiotape and a written User's Guide. There was no other intervention and no contact with participants between enrollment and the primary outcome assessment at 6 weeks. Analyses were based on intent to treat, with lost subjects counted as failures, and claimed abstinence was verified by carbon monoxide measures. Use of active patch produced significantly higher abstinence rates. Continuous abstinence rates (subject to a 2-week grace period) for nicotine and placebo were 19.4% and 7.0% at 6 weeks (OR = 3.2; 95% CI 1.8-5.4) and 15.2% and 5.3% at 10 weeks (OR = 3.2; 95% CI 1.7-5.9), respectively. Seven-day point-prevalence rates for nicotine and placebo patches were 26.1% and 7.7% at 6 weeks (OR = 4.2; 95% CI 2.5-7.0) and 23.3% and 7.7% at 10 weeks (OR = 3.6; 95% CI 2.2-6.1), respectively. Reported adverse events were mild and consistent with prior observations of nicotine patch use. The nicotine patch was safe and effective for smoking cessation at least during 10 weeks of treatment under open-sale conditions, without face-to-face instruction or counseling.