Journal of clinical psychopharmacology
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J Clin Psychopharmacol · Dec 2000
Randomized Controlled Trial Clinical TrialComparative abuse liability of intravenously administered remifentanil and fentanyl.
Remifentanil is a short-acting, esterase-metabolized opioid analgesic. This study compared the abuse liability of remifentanil with that of fentanyl and placebo in a randomized, double-blind, crossover study. Twelve recreational users of opioids received increasing doses of remifentanil (0.6, 1.2, 1.8, 2.4, and 3.0 microg/kg), fentanyl (0.4, 0.8, 1.3, 2.0, 3.0, and 4.5 microg/kg) and placebo via an intravenous infusion pump. ⋯ In contrast, observations that could only be made > or = 5 minutes after drug infusion predominantly indicated significantly greater fentanyl peak effects, including High VAS, Liking VAS, Good Effects VAS, and Cole/ARCI Abuse Potential. Fentanyl AUCs were generally significantly larger than the corresponding remifentanil AUCs. A drug abuser seeking longer-lasting drug effects might select fentanyl over remifentanil, but these data do not completely rule out remifentanil abuse by some individuals with access to both the drug and the infusion equipment or by those who prefer briefer, repeated effects.
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J Clin Psychopharmacol · Dec 2000
Randomized Controlled Trial Clinical TrialFirst-night effect of melatonin treatment in patients with chronic schizophrenia.
The first-night effect (FNE) is the tendency for individuals to sleep worse than normal during their first night of polysomnographic sleep evaluation. FNE reflects the adaptive increase of alertness and perhaps the stress resulting from an unfamiliar sleeping environment. This effect is usually absent in patients with chronic schizophrenia. ⋯ These effects were not found when the patients received a placebo. The FNE was manifested regardless of whether melatonin was administered before or after the placebo treatment period. For the first time, these results show that melatonin treatment exaggerates FNE in patients with chronic schizophrenia, thereby suggesting an improved ability of these patients to mobilize alertness in unfamiliar surroundings.
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J Clin Psychopharmacol · Aug 2000
Randomized Controlled Trial Clinical TrialPlacebo-controlled study of gabapentin treatment of panic disorder.
A randomized, double-blind, placebo-controlled, parallel-group study was conducted to evaluate the efficacy and safety of gabapentin in relieving the symptoms of panic disorder. One hundred three patients were randomly assigned to receive double-blind treatment with either gabapentin (dosed flexibly between 600 and 3,600 mg/day) or placebo for 8 weeks. No overall drug/placebo difference was observed in scores on the Panic and Agoraphobia Scale (PAS) (p = 0.606). ⋯ One patient experienced a serious adverse event during the study. No deaths were reported. The results of this study suggest that gabapentin may have anxiolytic effects in more severely ill patients with panic disorder.
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J Clin Psychopharmacol · Aug 2000
Randomized Controlled Trial Clinical TrialInhibition of cytochrome P450 2D6 modifies codeine abuse liability.
Oral codeine preparations, widely used for analgesia and cough suppression, are abused by some individuals for their mood-altering properties. The enzymatic O-demethylation of codeine is catalyzed by cytochrome P450 2D6 (CYP2D6), leading to the production of metabolites (morphine, morphine-6-glucuronide) that are pharmacologically more potent than codeine. A placebo-controlled, single-blind study was conducted to characterize the subjective effects of codeine associated with abuse liability and to determine the importance of metabolic O-demethylation to codeine abuse liability. ⋯ Single-dose quinidine pretreatment significantly decreased the recovery of O-demethylated metabolites in plasma (p < 0.01) and resulted in a decrease in the positive (e.g., "high," p < 0.05) and negative (e.g., nausea, p < 0.05) subjective effects of codeine in both the FD120 and FD180 groups. Short-term quinidine pretreatment inhibited codeine O-demethylation more than did single-dose quinidine pretreatment (p < 0.01), and it decreased positive codeine effects in the FD120 group (N = 7), but unexpectedly not in the FD180 group (N = 5). These results suggest that the O-demethylated metabolites contribute substantially to the subjective effects and abuse liability of codeine.
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J Clin Psychopharmacol · Jun 2000
Case ReportsAnorgasmia in a patient with bipolar disorder type 1 treated with gabapentin.
Gabapentin is a relatively new anticonvulsant indicated for adjunctive therapy in the treatment of partial seizures, with and without secondary generalization, in adults with epilepsy. Overall, it has a minimal side effect profile compared with other anticonvulsant agents. Postmarketing surveillance is needed to further delineate the spectrum of adverse events that may be experienced by patients treated with this medication. ⋯ The side effect profile and therapeutic monitoring requirements of gabapentin are favorable when compared with those of other anticonvulsant agents. However, because this agent is relatively new, especially for use in the treatment of bipolar disorder, a more thorough development of its side effect profile is needed. Observing, recording, and reporting atypical adverse events and side effects are critical to postmarketing surveillance and enhance the clinician's ability to make rational therapeutic decisions.