The Impact of the Opiate Antagonist Naltrexone on the Emotional Valence of Dreams

In this study, the investigators pose the question which influence the opioid circuit has on positive valent situations in dreams.

Study Overview

• Status: Completed
• Conditions: Neuroscience of Dreaming, Healthy
• Intervention / Treatment: Drug: Naltrexone; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 4

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3012
    • University of Bern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Written informed consent
• Healthiness
• Good capacity of remembering dreams
• No opiate consumption

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Baseline; reporting of dreams
Experimental: Naltrexone; daily administration of 50mg Naltrexone, reporting of dreams	Drug: Naltrexone; one week; Other Names: Naltrexin
Placebo Comparator: Placebo; daily administration of Placebo, reporting of dreams	Other: Placebo; one week; Other Names: Placebo Pills

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Semiquantitative score of emotional valence of dreams	Based on computational linguistic analysis of the dreams	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	7 days per condition (Baseline, Naltrexone, Placebo), intermitted by 14 days of washout

Collaborators and Investigators

• Sponsor: University of Bern
• Collaborators: University Hospital Inselspital, Berne
• Investigators: 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 record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: June 2, 2016
• First Submitted That Met QC Criteria: June 2, 2016
• First Posted (Estimate): June 7, 2016

Study Record Updates

• Last Update Posted (Actual): April 5, 2017
• Last Update Submitted That Met QC Criteria: April 4, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Psychology; Dreams
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Narcotic Antagonists; Alcohol Deterrents; Naltrexone
• Other Study ID Numbers: 2015DR2186

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED