Rewarding effects of physical activity predict sensitivity to the acute subjective effects ofd-amphetamine in healthy volunteers

Background A model for the testing of novel antimigraine drugs should ideally use healthy volunteers for ease of recruiting. Cilostazol provokes headache in healthy volunteers with some migraine features such as pulsating pain quality and aggravation by physical activity. Therefore, this headache might respond to sumatriptan, a requirement for validation. The hypothesis of the present study was that sumatriptan but not placebo is effective in cilostazol-induced headache in healthy individuals. Methods In a double-blind, randomized, cross-over design, 30 healthy volunteers of both sexes received cilostazol 200 mg on two separate days, each day followed by oral self-administered placebo or sumatriptan 50 mg. Headache response and accompanying symptoms were registered in a questionnaire by the participants themselves. Results Cilostazol induced a reproducible headache in 90% of the participants. The headache had several migraine-like features in most individuals. Median peak headache score was 2 on the sumatriptan day and 3 on the placebo day ( p = 0.17). There was no reduction in headache intensity two hours after sumatriptan ( p = 0.97) and difference in AUC 0 to four hours between two experimental days was not significant ( p = 0.18). On the placebo day eight participants took rescue medication compared to 3 on the sumatriptan day ( p = 0.13). Conclusion Despite similarities with migraine headache, cilostazol-induced headache in healthy volunteers does not respond to sumatriptan.

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The Relationship between Body Composition, Dietary Intake, Physical Activity, and Pulmonary Status in Adolescents and Adults with Cystic Fibrosis

Nutrients ◽

10.3390/nu14020310 ◽

2022 ◽

Vol 14 (2) ◽

pp. 310

Author(s):

Kevin J. Scully ◽

Laura T. Jay ◽

Steven Freedman ◽

Gregory S. Sawicki ◽

Ahmet Uluer ◽

...

Keyword(s):

Physical Activity ◽

Cystic Fibrosis ◽

Body Composition ◽

Dietary Intake ◽

Healthy Volunteers ◽

Clinical Outcomes ◽

Body Fat ◽

Lean Mass ◽

Cross Sectional ◽

Adolescents And Adults

Measures of body fat and lean mass may better predict important clinical outcomes in patients with cystic fibrosis (CF) than body mass index (BMI). Little is known about how diet quality and exercise may impact body composition in these patients. Dual X-ray absorptiometry (DXA) body composition, 24-h dietary recall, and physical activity were assessed in a cross-sectional analysis of 38 adolescents and adults with CF and 19 age-, race-, and gender-matched healthy volunteers. Compared with the healthy volunteers, participants with CF had a lower appendicular lean mass index (ALMI), despite no observed difference in BMI, and their diets consisted of higher glycemic index foods with a greater proportion of calories from fat and a lower proportion of calories from protein. In participants with CF, pulmonary function positively correlated with measures of lean mass, particularly ALMI, and negatively correlated with multiple measures of body fat after controlling for age, gender, and BMI. Higher physical activity levels were associated with greater ALMI and lower body fat. In conclusion, body composition measures, particularly ALMI, may better predict key clinical outcomes in individuals with CF than BMI. Future longitudinal studies analyzing the effect of dietary intake and exercise on body composition and CF-specific clinical outcomes are needed.

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Behavioral and Physiological Effects of Remifentanil and Alfentanil in Healthy Volunteers

Anesthesiology ◽

10.1097/00000542-199903000-00013 ◽

1999 ◽

Vol 90 (3) ◽

pp. 718-726 ◽

Cited By ~ 35

Author(s):

Matthew L. Black ◽

Joanna L. Hill ◽

James P. Zacny

Keyword(s):

Healthy Volunteers ◽

Dose Range ◽

Subjective Effects ◽

Cold Pressor Test ◽

Drug Effects ◽

Cold Pressor ◽

Psychomotor Tests ◽

Potency Ratio ◽

Psychomotor Effects ◽

Double Blinded

Background The subjective and psychomotor effects of remifentanil have not been evaluated. Accordingly, the authors used mood inventories and psychomotor tests to characterize the effects of remifentanil in healthy, non-drug-abusing volunteers. Alfentanil was used as a comparator drug. Methods Ten healthy volunteers were enrolled in a randomized, double-blinded, placebo-controlled, crossover trial in which they received an infusion of saline, remifentanil, or alfentanil for 120 min. The age- and weight-adjusted infusions (determined with STANPUMP, a computer modeling software package) were given to achieve three predicted constant plasma levels for 40 min each of remifentanil (0.75, 1.5, and 3 ng/ml) and alfentanil (16, 32, and 64 ng/ml). Mood forms and psychomotor tests were completed, and miosis was assessed, during and after the infusions. In addition, analgesia was tested at each dose level using a cold-pressor test. Results Remifentanil had prototypic micro-like opioid subjective effects, impaired psychomotor performance, and produced analgesia. Alfentanil at the dose range tested had more mild effects on these measures, and the analgesia data indicated that a 40:1 potency ratio, rather than the 20:1 ratio we used, may exist between remifentanil and alfentanil. A psychomotor test administered 60 min after the remifentanil infusion was discontinued showed that the volunteers were still impaired, although they reported feeling no drug effects. Conclusions The notion that the pharmacodynamic effects of remifentanil are extremely short-lived after the drug is no longer administered must be questioned given our findings that psychomotor effects were still apparent 1 h after the infusion was discontinued.

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Subjective effects of modafinil, a new central adrenergic stimulant in healthy volunteers: a comparison with amphetamine, caffeine and placebo

European Psychiatry ◽

10.1017/s0924933800002923 ◽

1993 ◽

Vol 8 (4) ◽

pp. 201-208 ◽

Cited By ~ 25

Author(s):

D Warot ◽

E Corruble ◽

C Payan ◽

JS Weil ◽

AJ Puech

Keyword(s):

Drug Abuse ◽

Healthy Volunteers ◽

Subjective Effects ◽

Abuse Liability ◽

Healthy Population ◽

Profile Of Mood States ◽

Double Blind ◽

Visual Analog Scales ◽

History Of ◽

Addiction Research Center Inventory

SummaryThe subjective, behavioral and physiological effects of modafinil (300 mg PO) a new central adrenergic stimulant, were compared with those of dextroamphetamine (15 mg PO), caffeine (300 mg PO) and placebo in a randomized double-blind cross-over study. Sixteen healthy volunteers participated in the study y: 8 males and 8 females with no history of drug abuse and moderate use of caffeine. Subjective and behavioral effects were studied using the Addiction Research Center Inventory (ARCI), Profile of Mood States (POMS) and Visual Analog Scales before and 1, 2, 4 and 8 h post single oral dosing. Results showed that subjective effects of modafinil (300 mg) differed markedly from those of dextroamphetamine (15 mg). They were close to those produced by caffeine (300 mg). These results indicate that modafinil (300 mg) does not possess amphetamine-like subjective effects in a healthy population. If subjective feelings are related to drug abuse liability, it could be assumed that modafinil, at the dose used in therapeutics, does not possess any abuse liability comparable to amphetamine.

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Characterization of the Psychomotor Impairing and Subjective Effects of Valerian in Healthy Volunteers

Anesthesiology ◽

10.1097/00000542-200209002-00284 ◽

2002 ◽

Vol 96 (Sup 2) ◽

pp. A284

Author(s):

Michael K. Ang-Lee ◽

James P. Zacny ◽

Chun-Su Yuan ◽

Diana J. Walker

Keyword(s):

Healthy Volunteers ◽

Subjective Effects

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Response to, “Cognitive, psychomotor and subjective effects of sodium oxybate and triazolam in healthy volunteers,” 2009; 206(1):141–154

Psychopharmacology ◽

10.1007/s00213-009-1662-9 ◽

2009 ◽

Vol 207 (3) ◽

pp. 509-510 ◽

Cited By ~ 1

Author(s):

Deborah L. Zvosec ◽

Stephen W. Smith

Keyword(s):

Healthy Volunteers ◽

Subjective Effects ◽

Sodium Oxybate

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Cognitive, psychomotor, and subjective effects of sodium oxybate and triazolam in healthy volunteers

Psychopharmacology ◽

10.1007/s00213-009-1589-1 ◽

2009 ◽

Vol 206 (1) ◽

pp. 141-154 ◽

Cited By ~ 32

Author(s):

Lawrence P. Carter ◽

Roland R. Griffiths ◽

Miriam Z. Mintzer

Keyword(s):

Healthy Volunteers ◽

Subjective Effects ◽

Sodium Oxybate

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A web-based adapted physical activity program (e-APA) versus health education program (e-HE) in patients with schizophrenia and healthy volunteers: study protocol for a randomized controlled trial (PEPSY V@Si)

10.21203/rs.2.456/v1 ◽

2019 ◽

Author(s):

Maxime Tréhout ◽

Elise Leroux ◽

Lucile Bigot ◽

Solenne Jego ◽

Pascal Leconte ◽

...

Keyword(s):

Physical Activity ◽

Health Education ◽

Healthy Volunteers ◽

Education Program ◽

Controlled Trial ◽

Active Group ◽

Health Education Program ◽

Web Based ◽

Physiological Variables ◽

Home Based

Abstract Background Patients with schizophrenia (SZ) present a higher level of cardiovascular morbidity than the general population due to poor physical fitness and a sedentary lifestyle. Moreover, despite major therapeutic advances in the management of SZ, some clinical symptoms remain resistant to pharmacological approaches. A large number of studies support the effectiveness of physical activity (PA) for both physical and mental health in SZ. The main objective of the present study is to assess the effects of a remote, web-based adapted PA program (e-APA) compared to a health education program (e-HE) on brain plasticity in SZ and healthy volunteers (HV). The secondary objectives are to assess the effects of e-APA on other cerebral variables as well as clinical, neurocognitive, circadian, biological, and physiological variables. Methods: The study is an interventional, multicenter, randomized open-label controlled trial. Forty-two SZ will be randomized to either the active group (e-APA, N = 21) or non-active group (e-HE, N = 21), and 42 HV will be matched to SZ according to age, gender, and level of PA. Interventions will consist of 32 sessions (2x60 minutes/week, for 16 weeks) via supervised home-based videoconferencing. The active group will carry out an individualized PA program of moderate to vigorous intensity. Pre- and post-intervention cerebral magnetic resonance imaging (MRI) will be performed to evaluate changes in global hippocampal volume. Other cerebral assessments using diffusion tensor imaging, arterial spin labelling, spectroscopy and resting-state functional MRI will be performed. In addition, clinical, neurocognitive and circadian rhythms assessments as well as physical tests and biological analyses will be conducted. Discussion: To our knowledge, this is the first study aiming to evaluate the efficacy of APA delivered by supervised home-based videoconferencing in SZ. Moreover, using multimodal MRI, this study could clarify the pathophysiological mechanisms underlying the efficacy of APA. Finally, this innovative approach (remote, web-based APA) might also increase participation in long-term PA since PA-based programs are known to have low adherence and early dropout. The results of this study should promote the inclusion of PA interventions as a novel adjunctive therapy for SZ. Trial registration: ClinicalTrials.gov identifier: NCT03261817. Registered on 16 August 2017.

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