Neuroscience of Dreaming, HealthyPhase 4NCT02792140
The Impact of the Opiate Antagonist Naltrexone on the Emotional Valence of Dreams
A Phase 4 study testing Naltrexone in people with Neuroscience of Dreaming, Healthy, run by University of Bern at 1 site in Switzerland.
Trial summary
In this study, the investigators pose the question which influence the opioid circuit has on positive valent situations in dreams. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Neuroscience of Dreaming, Healthy
- What is being tested?
- Naltrexone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2016to Nov 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Written informed consent
- Healthiness
- Good capacity of remembering dreams
- No opiate consumption
Who cannot join
- Simultaneous participation in other studies
- Addictive disorder
- Abnormal liver function
- Abnormal kidney function
- Hypersensitivity to active ingredient or pharmaceutical additives
- Hereditary galactose intolerance
Show all 9Show fewer
- Lactase deficiency
- Glucose-galactose malabsorption
- Intake of opioid medication
Trial locations and contacts
1 site in 1 country.
About this study
In this study, the investigators pose the question which influence the opioid circuit has on positive valent situations in dreams.
- Conditions
- Neuroscience of Dreaming, Healthy
- Being tested
- Naltrexone, Placebo
- Keywords
- Psychology, Dreams
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaltrexoneDrug
Also called Naltrexin
one week
PlaceboOther
Also called Placebo Pills
one week
| Study group | Role | What they receive |
|---|---|---|
| Baseline | No intervention | reporting of dreams |
| Naltrexone | Experimental | daily administration of 50mg Naltrexone, reporting of dreams Receives: Drug: Naltrexone |
| Placebo | Placebo comparator | daily administration of Placebo, reporting of dreams Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7 days per condition (Naltrexone, Placebo), intermitted by 14 days of washout
Secondary outcomes (2)
Semiquantitative score of emotional valence of dreams
Based on computational linguistic analysis of the dreams
Measured: 7 days per condition (Baseline, Naltrexone, Placebo), intermitted by 14 days of washout
Qualitative score of emotional valence of dreams
Based on lexical coding of the dreams
Measured: 7 days per condition (Baseline, Naltrexone, Placebo), intermitted by 14 days of washout
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2016 (estimated)
- Study startMar 2016
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroscience of Dreaming, HealthyStudies of the same condition, open and under way.
- More trials run by University of BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Insel Gruppe AG, University Hospital Bern
- Responsible party
- Sponsor
- Investigators
- Fred Mast, Prof. Dr. phil., Study director, Head of Cognitive Psychology, Perception and Research Methods, Dean Human Sciences Faculty, Ordinarius, University of BernClaudio L. Bassetti, Prof. Dr. med., Principal investigator, Chairman and Head, Department of Neurology Inselspital, Bern University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02792140
- Sponsor's protocol ID
- 2015DR2186
- Status last verified
- Apr 2017
- First submitted
- 2 Jun 2016
- Last updated
- 5 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of the Opiate Antagonist Naltrexone on the Emotional Valence of Dreams
- ClinicalTrials.gov ID
- NCT02792140
- Acronym / sponsor ID
- 2015DR2186
- Conditions
- Neuroscience of Dreaming, Healthy
- Keywords
- Psychology, Dreams
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Collaborators
- Insel Gruppe AG, University Hospital Bern
- Study start
- Mar 2016 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 7 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, the investigators pose the question which influence the opioid circuit has on positive valent situations in dreams.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Baseline | No intervention | –reporting of dreams |
| Naltrexone | Experimental | Drug: Naltrexonedaily administration of 50mg Naltrexone, reporting of dreams |
| Placebo | Placebo comparator | Other: Placebodaily administration of Placebo, reporting of dreams |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Written informed consent
- Healthiness
- Good capacity of remembering dreams
- No opiate consumption
Key exclusion criteria (9 listed)
- Simultaneous participation in other studies
- Addictive disorder
- Abnormal liver function
- Abnormal kidney function
- Hypersensitivity to active ingredient or pharmaceutical additives
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NaltrexoneAlso: Naltrexinone week | Drug | Naltrexone |
| PlaceboAlso: Placebo Pillsone week | Other | Placebo |
Primary outcome
VAS-difference concerning the emotional valence of dreams
Time frame: 7 days per condition (Naltrexone, Placebo), intermitted by 14 days of washout
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
2 secondary outcomes
Semiquantitative score of emotional valence of dreams
Time frame: 7 days per condition (Baseline, Naltrexone, Placebo), intermitted by 14 days of washout
Qualitative score of emotional valence of dreams
Time frame: 7 days per condition (Baseline, Naltrexone, Placebo), intermitted by 14 days of washout
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2017.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fred Mast, Prof. Dr. phil. study director
Head of Cognitive Psychology, Perception and Research Methods, Dean Human Sciences Faculty, Ordinarius, University of Bern
Claudio L. Bassetti, Prof. Dr. med. principal investigator
Chairman and Head, Department of Neurology Inselspital, Bern University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Naltrexone in people with Neuroscience of Dreaming, Healthy, run by University of Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS-difference concerning the emotional valence of dreams (time frame: 7 days per condition (Naltrexone, Placebo), intermitted by 14 days of washout). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2017.