The Impact of the Opiate Antagonist Naltrexone on the Emotional Valence of Dreams
1 other identifier
interventional
32
1 country
1
Brief Summary
In this study, the investigators pose the question which influence the opioid circuit has on positive valent situations in dreams.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Mar 2016
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 2, 2016
CompletedFirst Posted
Study publicly available on registry
June 7, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedApril 5, 2017
April 1, 2017
8 months
June 2, 2016
April 4, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
VAS-difference concerning the emotional valence of dreams
Difference between the mean values of emotional valence of dreams reported in the conditions (Naltrexone, Placebo), as captured in VAS \[visual analog scales\] for every dream
7 days per condition (Naltrexone, Placebo), intermitted by 14 days of washout
Secondary Outcomes (2)
Semiquantitative score of emotional valence of dreams
7 days per condition (Baseline, Naltrexone, Placebo), intermitted by 14 days of washout
Qualitative score of emotional valence of dreams
7 days per condition (Baseline, Naltrexone, Placebo), intermitted by 14 days of washout
Study Arms (3)
Baseline
NO INTERVENTIONreporting of dreams
Naltrexone
EXPERIMENTALdaily administration of 50mg Naltrexone, reporting of dreams
Placebo
PLACEBO COMPARATORdaily administration of Placebo, reporting of dreams
Interventions
Eligibility Criteria
You may qualify if:
- Written informed consent
- Healthiness
- Good capacity of remembering dreams
- No opiate consumption
You may not qualify if:
- Simultaneous participation in other studies
- Addictive disorder
- Abnormal liver function
- Abnormal kidney function
- Hypersensitivity to active ingredient or pharmaceutical additives
- Hereditary galactose intolerance
- Lactase deficiency
- Glucose-galactose malabsorption
- Intake of opioid medication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Bernlead
- Insel Gruppe AG, University Hospital Berncollaborator
Study Sites (1)
University of Bern
Bern, Canton of Bern, 3012, Switzerland
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Fred Mast, Prof. Dr. phil.
Head of Cognitive Psychology, Perception and Research Methods, Dean Human Sciences Faculty, Ordinarius, University of Bern
- PRINCIPAL INVESTIGATOR
Claudio L. Bassetti, Prof. Dr. med.
Chairman and Head, Department of Neurology Inselspital, Bern University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2016
First Posted
June 7, 2016
Study Start
March 1, 2016
Primary Completion
November 1, 2016
Study Completion
November 1, 2016
Last Updated
April 5, 2017
Record last verified: 2017-04