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Double-blind Conditions (double-blind + condition)
Selected AbstractsSmoking cessation during alcohol treatment: a randomized trial of combination nicotine patch plus nicotine gumADDICTION, Issue 9 2009Ned L. Cooney ABSTRACT Aims The primary aim was to compare the efficacy of smoking cessation treatment using a combination of active nicotine patch plus active nicotine gum versus therapy consisting of active nicotine patch plus placebo gum in a sample of alcohol-dependent tobacco smokers in an early phase of out-patient alcohol treatment. A secondary aim was to determine whether or not there were any carry-over effects of combination nicotine replacement on drinking outcomes. Design Small-scale randomized double-blind placebo-controlled clinical trial with 1-year smoking and drinking outcome assessment. Setting Two out-patient substance abuse clinics provided a treatment platform of behavioral alcohol and smoking treatment delivered in 3 months of weekly sessions followed by three monthly booster sessions. Participants Participants were 96 men and women with a diagnosis of alcohol abuse or dependence and smoking 15 or more cigarettes per day. Intervention All participants received open-label transdermal nicotine patches and were randomized to receive either 2 mg nicotine gum or placebo gum under double-blind conditions. Findings Analysis of 1-year follow-up data revealed that patients receiving nicotine patch plus active gum had better smoking outcomes than those receiving patch plus placebo gum on measures of time to smoking relapse and prolonged abstinence at 12 months. Alcohol outcomes were not significantly different across medication conditions. Conclusions Results of this study were consistent with results of larger trials of smokers without alcohol problems, showing that combination therapy (nicotine patch plus gum) is more effective than monotherapy (nicotine patch) for smoking cessation. [source] A double-blind, placebo-controlled trial of modafinil (200 mg/day) for methamphetamine dependenceADDICTION, Issue 2 2009James Shearer ABSTRACT Aim To examine the safety and efficacy of modafinil (200 mg/day) compared to placebo in the treatment of methamphetamine dependence and to examine predictors of post-treatment outcome. Participants and design Eighty methamphetamine-dependent subjects in Sydney, Australia were allocated randomly to modafinil (200 mg/day) (n = 38) or placebo (n = 42) under double-blind conditions for 10 weeks with a further 12 weeks post- treatment follow-up. Measures Comprehensive drug use data (urine specimens and self-report) and other health and psychosocial data were collected weekly during treatment and research interviews at baseline, week 10 and week 22. Results Treatment retention and medication adherence were equivalent between groups. There were no differences in methamphetamine abstinence, craving or severity of dependence. Medication-compliant subjects tended to provide more methamphetamine-negative urine samples over the 10-week treatment period (P = 0.07). Outcomes were better for methamphetamine-dependent subjects with no other substance dependence and those who accessed counselling. There were statistically significant reductions in systolic blood pressure (P = 0.03) and weight gain (P = 0.05) in modafinil-compliant subjects compared to placebo. There were no medication-related serious adverse events. Adverse events were generally mild and consistent with known pharmacological effects. Conclusions Modafinil demonstrated promise in reducing methamphetamine use in selected methamphetamine-dependent patients. The study findings support definitive trials of modafinil in larger multi-site trials. [source] Individual Differences in Responses to Ethanol and d-Amphetamine: A Within-Subject StudyALCOHOLISM, Issue 4 2001Louis Holdstock Background: In some individuals, ethanol (EtOH) produces marked stimulant-like subjective effects resembling those of stimulant drugs, like d-amphetamine (AMP). In this study, we examined the neurochemical basis of these individual differences by examining the same subjects' responses to both EtOH and AMP. A positive correlation between subjects' responses to the two drugs may suggest that AMP and EtOH produce their stimulant-like subjective effects by a shared mechanism. Methods: Twenty-seven volunteers (17 male, 10 female), aged 21,35, received beverages or capsules containing EtOH 0.8 g/kg, AMP 10 or 20 mg, or placebo on four separate sessions in random order and under double-blind conditions. Various self-reported and objective drug effects were measured, including measures sensitive to subjective and cognitive stimulant-like effects. Results: EtOH and AMP produced their prototypical subjective and behavioral effects, including increased ratings of stimulant-like subjective effects, increased heart rate and blood pressure, and improved vigilance performance after AMP and increased ratings of sedative-like subjective effects, increased heart rate and blood pressure, and impaired vigilance performance after EtOH. Consistent with previous reports, there was substantial intersubject variability in subjective responses to EtOH: some subjects reported primarily stimulant-like effects, whereas others reported primarily sedative-like effects. To examine the relationship between these responses to EtOH and subjects' responses to AMP, correlations were examined between effects of EtOH and AMP. For all subjects together, there was a significant positive correlation between responses to EtOH and 20 mg AMP on the ARCI A scale (a measure of stimulant-like subjective effects;r= 0.41, p < 0.05). Among only those subjects who reported primarily stimulant-like effects from EtOH, the correlation between EtOH and AMP was 0.64 (p < 0.05). Conclusions: Subjects who experience pronounced stimulant-like effects from EtOH also report greater stimulant effects from AMP, suggesting that these effects may be mediated through similar mechanisms. These correlations between the drugs' effects were not observed on other measures, such as DSST or vigilance task performance or heart rate. This may indicate that these other effects are mediated by separate mechanisms. The study illustrates a novel approach to studying the neurochemical basis of drug effects. [source] Acute neuropsychological effects of methylphenidate in stimulant drug-naïve boys with ADHD II , broader executive and non-executive domainsTHE JOURNAL OF CHILD PSYCHOLOGY AND PSYCHIATRY AND ALLIED DISCIPLINES, Issue 11 2006Sinéad M. Rhodes Background:, Accumulating evidence supports methylphenidate-induced enhancement of neuropsychological functioning in attention deficit hyperactivity disorder (ADHD). The present study was designed to investigate the acute effects of the psychostimulant drug, methylphenidate (MPH), on neuropsychological performance in stimulant naïve boys with ADHD. Methods:, Seventy-three drug-naïve boys (age 7,15) with ADHD (combined type) completed neuropsychological tasks from the CANTAB battery under randomised, placebo controlled, double-blind conditions following an acute challenge with either placebo (n = 24), .3 (n = 25) or .6 (n = 24) mg/kg oral MPH. Results:, MPH did not impair performance on any task. MPH (.6 mg/kg) lengthened response latencies on a task of Spatial Recognition, shortened response times on a Reaction Time task and restored performance on a Delayed Matching to Sample visual, non-working memory task. Contrary to predictions, MPH did not enhance performance on tasks with a prominent executive component, including Go/NoGo, Spatial Working Memory, Stockings of Cambridge and Attentional Set shifting tasks. Conclusions:, Acute administration of MPH to drug-naïve boys with ADHD did not impair neuropsychological performance. Acute MPH enhanced performance on some aspects of non-executive functioning. MPH-induced slowing of responding on a relatively complex Spatial Recognition memory task and quickened responding on a reaction time task requiring less cognitive resources suggests that MPH may act by improving self-regulatory ability. MPH may not exert its effects on neuropsychological functioning by enhancing executive processes. [source] | ||||||||||