TerminatedNCT03854942Updated Sep 12, 2019

Study of the Opioid Modulation of the Effect of Alcohol on the Dopaminergic Reward System

A Phase 1 interventional study of Placebo and Naltrexone in Alcohol Addiction, sponsored by RWTH Aachen University. Terminated at 1 site in Germany. Open to male participants aged 21 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-12.

Sponsored by RWTH Aachen University · Phase 1, Interventional, and Treatment

Why this study was terminated

Recruitment rate could not be met in the study period, review group was dissolved before regular end of study. Recruitment was therefore terminated.

From the registry’s dates

Registered 7 years 5 months after the study started (first participant enrolled Aug 2011, registered Feb 2019).

Phase: Phase 1
Study type: Interventional
Enrollment: 43
Allocation: Randomized
Ages: 21 Years to 45 Years
Sex: Male

Study summary

About 10% of the calculable loss of health and quality of life in industrial countries can be attributed to excessive alcohol consumption. Behavioural pharmacological, genetic and clinical studies on alcohol dependence suggest a multifactorial model for the development of the disease, which ascribes an important role in the development of the disease to genetic variance, educational style and continued substance use. Animal and human experimental studies suggest that continued alcohol consumption leads to a pathological activation of the mesolimbic reward system. In the presented study, the modification of the alcohol-mediated activation of the mesolimbic reward system by the administration of the opiate antagonist naltrexone will be investigated in a human in vivo model. The aim is to gain important insights for the further development of pharmacological treatment options for alcohol dependence. Further development of pharmacological treatment options for alcohol dependence seems urgently necessary in order to slow down the high tendency to relapse and prolong the short abstinence period.

Conditions studied

Alcohol Addiction

Browse trials for

Alcoholism 1,606

In context

Alcoholism

1,606 studies on the registry are indexed under Alcoholism; 329 are open to participants now.

This study's enrollment of 43 is below the median of 87 across 1,371 interventional studies indexed under Alcoholism.

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Lead sponsor

RWTH Aachen University is the lead sponsor of 228 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 21 Years to 45 Years
Sexes eligible: Male
Accepts healthy volunteers: Yes

Inclusion criteria

age: 21-45 years
The subject is able to understand the nature, extent and individual consequences of the clinical trial
Maintained ability to give consent, certified by a psychiatrist (specialist)
A personally dated informed consent form signed by the test participant
No current and/or historical psychiatric disorder (secured by standardized psychiatric interview (DIAX: Composite International Diagnostic Interview))
Non-smokers (no nicotine addiction within the last 6 months prior to sequential allocation)
OPRM1 Asp40 carrier (functional polymorphism in amino acid residue 40 of μ-opioid receptor gene (OPRM1)) (in AC for inclusion in first and third treatment arm)
Highly effective contraception method with a failure rate of \<1%: Hormonal contraceptive methods (oral: "contraceptive pill", incl. combined oral contraceptives; subcutaneous implants; injectable contraceptives); intrauterine pessary, vasectomy of the partner, tube ligation ("sterilisation") or sexual abstinence
Persons who are legally competent and mentally able to understand and follow the instructions of the study staff
MRI capability

Exclusion criteria

Exclusion Criteria:

hypersensitivity to the investigational product or a chemically similar substance or component of the investigational product
Participation in other clinical trials during or within 6 months prior to this clinical trial
Medical or psychological circumstances which may jeopardise the proper conduct of the clinical trial
Physical illnesses which could interfere with the planned examinations according to their type and severity, could have an influence on the parameters to be examined or could endanger the volunteer during the course of the examination
Inability to adhere to the study protocol
Limited or completely revoked legal capacity
Acute suicidal tendency or external hazard
Poor overall condition
Participation in a study using ionising radiation in the last five years.
Regular medication (e.g. MAO inhibitors)
Alcohol abuse, alcohol dependency or addiction illness / abuse of addictive substances in history
Existence of other exclusion criteria for participation in MRI examinations (non-removable metal parts in the body, left-handedness, pacemakers)
Known hypersensitivity to carbidopa or any of the other components
Relevant organic diseases: in particular: Narrow angle glaucoma, vascular diseases, central nervous neurological diseases; body weight of more than 150 kg (contraindications PET - scan)
Clinically significant deviations in clinical chemistry or haematology or clinically significant abnormalities
Melanoma-specific skin lesions or anamnesis of a previous melanoma disease
Persons who are accommodated in an establishment by court order or official order
Persons who are dependent on or have an employment relationship with the sponsor or investigator

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential assignment
Masking: Single (Participant)
Enrollment: 43 participants (actual)

Study arms

Other
First Arm
7 days placebo intake - i.v. injection of physiological saline solution (0,9%) - PET followed by 7 days placebo intake - i.v. injection of ethanol solution (6 Vol.-%) - PET
Drug: Placebo
Other
Second Arm
7 days placebo intake - i.v. injection of physiological saline solution (0,9%) - PET - 7 days naltrexone intake (Nemexin, 50 mg once daily during the first 2 days, 100 mg daily for the following 5 days) - injection of physiological saline solution (0,9%) - PET
Drug: Placebo · Drug: Naltrexone
Other
Third Arm
7 days placebo intake - i.v. injection of ethanol solution (6 Vol.-%) - PET - 7 days naltrexone (Nemexin, 50 mg once daily during the first 2 days, 100 mg daily for the following 5 days) intake - i.v. injection of ethanol solution (6 Vol.-%) - PET
Drug: Placebo · Drug: Naltrexone

Interventions

DrugPlacebo
Placebo oral tablet daily
DrugNaltrexone
Naltrexone (Nemexin) oral tablet 50 mg daily for 2 days, Naltrexone (Nemexin) oral tablet 100 mg daily for 5 days

What researchers measure

Primary outcomes

Pharmacological effect of naltrexone on the dopamine synthesis rate of a healthy OPRM1 Asp40-bearing men under the influence of alcohol measured with [18F]-fluoro-DOPA PET.
Time frame: 28 days
Dopamine D2 receptor availability in the structures of the ventral and dorsal striatum of a healthy µ-opioid receptor gen (OPRM1, Asp40 Allel)-bearing men under the influence of alcohol measured with [18F]-fallypride Positron Emission Tomography.
Time frame: 28 days

Secondary outcomes

Pharmacological effect of ethanol on dopamine D2 receptor availability in healthy men measured with [18F]-fallypride Positron Emission Tomography.
Time frame: 28 days
Pharmacological effect of ethanol on the dopamine synthesis rate of the ventral and dorsal striatum in healthy men measured with [18F]-fluoro-DOPA PET.
Time frame: 28 days
Pharmacological effect of Naltrexone on dopamine D2 receptor availability in healthy men measured with [18F]-fallypride Positron Emission Tomography.
Time frame: 28 days
Pharmacological effect of Naltrexone on the dopamine synthesis rate of ventral and dorsal striatum in healthy men measured with [18F]-fluoro-DOPA PET.
Time frame: 28 days

Other outcomes

Modulation of extrastriatal dopamine D2/D3 receptor availability measured with [18F]-fallypride in structures of the anterior cingulum using Positron Emission Tomography.
Time frame: 28 days
Relationship between impulsive behaviour and functionality of the dopamine synthesis rate and dopamine D2 receptor availability
Evaluation of impulsive behaviour using BIS (Barratt Impulsiveness Scale) questionnaire
Time frame: 28 days
Relationship between impulsive behaviour and functionality of the dopamine synthesis rate and dopamine D2 receptor availability
Evaluation of impulsive behaviour using Neo-FFI (NEO-Fünf-Faktoren-Inventar) questionnaire
Time frame: 28 days
Relationship between impulsive behaviour and functionality of the dopamine synthesis rate and dopamine D2 receptor availability
Evaluation of impulsive behaviour using I7 (Impulsivitätsfragebogen (impulsivity questionnaire) nach Eysenck) questionnaire
Time frame: 28 days
Interaction between subjective alcohol effects and placebo/naltrexone effects
Exploratively, the interaction between subjective alcohol effects and placebo/naltrexone effects will be investigated using VAS (visual analogue scale of alcoholic desire) questionnaire.
Time frame: 28 days
Interaction between subjective alcohol effects and placebo/naltrexone effects
Exploratively, the interaction between subjective alcohol effects and placebo/naltrexone effects will be investigated using OCDS (Obsessive Compulsive Drinking Scale) questionnaire.
Time frame: 28 days
Interaction between subjective alcohol effects and placebo/naltrexone effects
Exploratively, the interaction between subjective alcohol effects and placebo/naltrexone effects will be investigated using ESA (Erfassung subjektiver Alkoholwirkungen (Determination of subjective alcohol effects)) questionnaire.
Time frame: 28 days

Study locations

1 site

University Hospital RWTH Aachen
Aachen, 52074, Germany

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 12, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03854942
Lead sponsor: RWTH Aachen University
Responsible party: Sponsor
First posted: Feb 26, 2019
Start date: Aug 30, 2011
Primary completion: Dec 13, 2017
Completion: Dec 13, 2017
Last update: Sep 12, 2019

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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