balanced placebo design

A trial design in which participants are recruited for a study where either an active drug or a placebo will be administered. Half of the participants are told they are receiving the active drug and half are told they are receiving the placebo—but in both groups, only half of the participants therein actually receive the drug or placebo as told, i.e., half are intentionally misinformed about which arm they are in. This permits independent and combined assessment of drug and placebo effects.

The balanced placebo design is useful because it provides a direct assessment of the drug effect, independent of expectancy. It has most commonly been deployed to test the role of expectancy on the effects of alcohol and caffeine consumption, usually with healthy volunteers. It has the advantage that the “told receiving drug”/“received drug” non-deceptive arm has more external validity than the double-blind administration in conventional randomised trials, because they more accurately represent what happens in clinical practice.

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References in periodicals archive

Di questi uno studio presenta, inoltre, un balanced placebo design (28), in cui lo stesso gruppo di soggetti viene sottoposto a 4 differenti condizioni (suggestione sostanza attiva-somministrazione sostanza attiva, suggestione sostanza attiva-somministrazione placebo, suggestione placebo-somministrazione sostanza attiva, suggestione placebo-somministrazione placebo).

Placebo effect during the performance of motor tasks in healthy subjects: a systematic review of literature/Effetto placebo nell'esecuzione di task motori in soggetti sani: revisione sistematica della letteratura

Studies employing a balanced placebo design to examine the effects of alcohol consumption often report that the non-alcoholic placebo beverage used was credible as an alcoholic drink.

Studies often employ a balanced placebo design (Hull and Bond, 1986), where a low or nonalcoholic beverage serves as a control treatment, allowing for the effects of an alcohol intervention to be compared against a control.

Development and effectiveness of a placebo beverage similar in sensory properties to an alcoholic beverage

Foad et al., (2008) used the balanced placebo design (Marlatt and Rohsenow, 1980) in an attempt to quantify the respective pharmacological and psychological contributions to the ergogenic effects of caffeine in 40-km cycling performance.

(1980) Cognitive approaches in alcohol use: Expectancy and the balanced placebo design. In: Advances in substance abuse: Behavioural and biological research.

Identification of placebo responsive participants in 40km laboratory cycling performance

* A variation on the balanced placebo design is used, along with a within-subjects design, in order to estimate the effects of conditioned tolerance and expectancy, compared to unconditioned alcohol responses and a control placebo condition.

Although the sample is not large enough to do a complex regression analysis, we will present comparisons of the different conditions of the balanced placebo design. Correlations among predictor variables and selected dependent variables will also be presented.

Individual differences in human alcohol responses