A randomized, double blind, placebo-controlled, double dummy, three-way crossover study to investigate the effects of an intravenous ethanol clamp and a morphine infusion on resting state functional magnetic resonance imaging in healthy male volunteers

Conditions: Er zal bij deze studie niet gekeken worden naar de aandoening die het middel behandelt. De farmacodynamische effecten van morfine/ethanol op resting state networks in de hersenen zullen worden bestudeerd.
not applicable

Registration Number: NL-OMON31294

Lead Sponsor: Centre for Human Drug Research

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 12

Inclusion Criteria

a. Subject is a legally competent male adult between 18 and 40 years old, extremes included.;b. Subject is neither grossly overweight nor underweight for height and body build. BMI of 18 - 26 kg.m-2, extremes included.;c. Subject is familiar with the procedures of the study, and agrees to participate in the study program by giving oral and written informed consent.;d. Subject is familiar with the use and effects of alcohol.

Exclusion Criteria

a. Subject has a (history of) a significant medical disorder that may pose a risk for the subject or jeopardize the aims of the study, based on medical history, physical examination, ECG and safety laboratory parameters.;b. Subject has a positive screen for Hepatitis B, C and HIV.;c. Subject uses more than 4 alcoholic consumptions per day, on average.;d. Subject has a significant history of any cardiac or vascular disorder, asthma or other pulmonary disease, major gastrointestinal abnormalities/peptic ulceration, hepatic, neurological, psychiatric, haematological (including bleeding disorders), endocrine, renal, or major genitourinary disease or uses any kind of concomitant medication that - in the opinion of the investigator - may interfere with the study.;e. Subject has a history of illness or any condition that, in the opinion of the investigator, might interfere with optimal participation, confound the results of the study or pose additional risk in administering ethanol or morphine to the subject (e.g. opioid allergy).;f. Subject smokes more than 5 cigarettes per day or is unable to refrain from smoking on the study days.;g. Subject has participated in a trial within 3 months prior to the start of the study or subject has participated in more than 4 clinical trials in the last year.;h. Subject has donated blood (including blood sampling during clinical trails) in the past 3 months.;i. Subject is a habitual and heavy consumer of caffeinated beverages (more than 6
cups of coffee or equivalent/day) at the time of the study.;j. Subject is currently a regular user (including *recreational uses*) of any illicit drugs, or has (a history of) drug or alcohol abuse.;k. Subject is unable to refrain from quinine containing products and grapefruit or grapefruit juice from 14 days prior to study start until the last study day.;l. Subject is provided with metal medical devices like pacemakers, knee or hip prothesis, earimplants, vesselclips, subcutaneous insuline pumps or carries metal particles (e.g. metal splinter in the eye) inside the body.;m. Subject has a significant history of claustrophobia.;n. Subject has a professional involvement in the study or is an investigator*s relative.;o. Subject is not able to maintain a regular diurnal rhythm.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>CNS Pharmacodynamics<br /><br>• Visual Analogue Scales (VAS) to assess mood, alertness and calmness (Bond<br /><br>and Lader),<br /><br>• VAS to assess the subjective effects of ethanol,<br /><br>• VAS to assess the subjective feeling of nausea,<br /><br>• VAS to assess psychedelic effects (Bowdle).<br /><br><br /><br>fMRI<br /><br>• Resting State Network (RSN) activity<br /><br><br /><br>Pharmacokinetics<br /><br>• Breath ethanol concentrations,<br /><br>• Plasma morphine, morphine-3-glucuronide (M3G) and morphine-6-<br /><br>glucuronide (M6G) levels.</p><br>

Secondary Outcome Measures