Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2021-03-09
2022-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
QUADRUPLE
Study Groups
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Opium tincture
Administration of opium tincture (Dropizol)
Opium tincture
Self-administration of opium tincture (10 mg/ml) as 2x5 drops on day 1, 3x10 drops on days 2-8, and 1x10 drops on day 9 in each study period.
Placebo
Administration of placebo (identical to opium tincture in taste and appearance)
Placebo
Self-administration of placebo as 2x5 drops on day 1, 3x10 drops on days 2-8, and 1x10 drops on day 9 in each study period.
Interventions
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Opium tincture
Self-administration of opium tincture (10 mg/ml) as 2x5 drops on day 1, 3x10 drops on days 2-8, and 1x10 drops on day 9 in each study period.
Placebo
Self-administration of placebo as 2x5 drops on day 1, 3x10 drops on days 2-8, and 1x10 drops on day 9 in each study period.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Able to read and understand Danish
* Male or female with an age of 20 years or more
* The researcher believes that the participant understands what the study entails, are capable of following instructions, can attend when needed, and are expected to complete the study.
* The investigator will ensure that fertile female participants have a negative pregnancy test before each treatment visit and use contraception during the entity of the study.
* Opioid naïve (in this study "opioid naïve" is defined as a person who does not have a history of opioid use/addiction. If the opioids were used more than five years before the start of experiment as an analgesic to treat pain post-surgery etc., this person will be considered opioid naïve. If the person has never used opioids to treat pain but has participated in pain studies where opioids were given more than a year before this experiment, this person will be considered opioid naïve)
* Healthy (assessed by a study-affiliated medical doctor)
Exclusion Criteria
* Participation in other studies within 14 days of first visit (1 year if opioids involved).
* Expected need of medical/surgical treatment during the study
* History of psychiatric illness (e.g. mental retardation, schizophrenia, affective disorders (depression), personality disorders or treatment with psychoactive medications)
* History of substance abuse (e.g. alcohol, nicotine, tetrahydrocannabinol (THC), benzodiazepine, central stimulants and/or opioids)
* Family history of substance abuse
* Known increased intracranial pressure
* Known major stenosis of the intestines
* Planned MRI within the next 3 months
* Metal implants or pacemaker
* Known severe decreased renal function (defined as estimated glomerular filtration rate (eGFR) below 45)
* Known severe decreased hepatic function (defined as Child-Pugh class B or higher)
* Treatment with Monoamine oxidase (MAO) inhibitors during the entity of the study
* Known severe chronic obstructive pulmonary disease (COPD) or acute severe asthma (defined as forced expiratory volume in 1 second (FEV1) below 50 % or acute ongoing exacerbation)
* Known cor pulmonale
* Female participants that are lactating
* Medicine known to affect gastrointestinal motility must not be initiated during the entity of the study
* Use of any analgesic medication within 48 hours before start as well as for the duration of the study (urine drug test will be performed prior to treatment start).
* Intake of alcohol within 48 hours before start of study period as well as for the duration of the study.
20 Years
ALL
Yes
Sponsors
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Asbjørn Mohr Drewes
OTHER
Responsible Party
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Asbjørn Mohr Drewes
Professor
Principal Investigators
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Asbjørn Mohr Drewes
Role: PRINCIPAL_INVESTIGATOR
Aalborg University Hospital
Locations
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Aalborg University Hospital
Aalborg, , Denmark
Countries
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Other Identifiers
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2020-004875-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
Dropizol_healthy
Identifier Type: -
Identifier Source: org_study_id
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