M A Flaten1, T Simonsen, H Olsen. 1. Department of Psychology, University of Tromsø, Norway. magne.flaten@svt.ntnu.no
Abstract
OBJECTIVE: Administration of the muscle relaxant carisoprodol and placebo was crossed with information that was agonistic or antagonistic to the effect of carisoprodol. It was investigated whether information alone induced physiological and psychological responses, and whether information modified the response to the drug. METHODS: Half of the subjects received capsules containing 525 mg carisoprodol together with information that the drug acted in a specific way (Groups Relaxant/C, Stimulant/C, and No Information/C). The other half of the subjects received lactose (Groups Relaxant/L, Stimulant/L, and No Information/L). Dependent variables were blink reflexes and skin conductance responses, subjective measures of tension and sleepiness, and serum carisoprodol and meprobamate concentrations. Recordings were made between 15 and 130 minutes after administration of the capsules. RESULTS: The Stimulant/L group reported more tension compared with the other two groups, and carisoprodol increased tension even more in the Stimulant/C group. The Relaxant/C group displayed higher levels of carisoprodol serum concentration compared with the other groups that received carisoprodol. CONCLUSIONS: Reported tension was modulated in the direction suggested by the stimulant information. The effect of carisoprodol on tension was also modulated by stimulant information. Increased carisoprodol absorption in the group that received relaxant information could be a mechanism in the placebo response.
RCT Entities:
OBJECTIVE: Administration of the muscle relaxant carisoprodol and placebo was crossed with information that was agonistic or antagonistic to the effect of carisoprodol. It was investigated whether information alone induced physiological and psychological responses, and whether information modified the response to the drug. METHODS: Half of the subjects received capsules containing 525 mg carisoprodol together with information that the drug acted in a specific way (Groups Relaxant/C, Stimulant/C, and No Information/C). The other half of the subjects received lactose (Groups Relaxant/L, Stimulant/L, and No Information/L). Dependent variables were blink reflexes and skin conductance responses, subjective measures of tension and sleepiness, and serum carisoprodol and meprobamate concentrations. Recordings were made between 15 and 130 minutes after administration of the capsules. RESULTS: The Stimulant/L group reported more tension compared with the other two groups, and carisoprodol increased tension even more in the Stimulant/C group. The Relaxant/C group displayed higher levels of carisoprodol serum concentration compared with the other groups that received carisoprodol. CONCLUSIONS: Reported tension was modulated in the direction suggested by the stimulant information. The effect of carisoprodol on tension was also modulated by stimulant information. Increased carisoprodol absorption in the group that received relaxant information could be a mechanism in the placebo response.
Authors: Winfried Rief; Yvonne Nestoriuc; Anna von Lilienfeld-Toal; Imis Dogan; Franziska Schreiber; Stefan G Hofmann; Arthur J Barsky; Jerry Avorn Journal: Drug Saf Date: 2009 Impact factor: 5.606