Alcohol Use DisorderPhase 2/3ON-ICENCT05093296

Oxytocin and Naltrexone: Investigation of Combined Effects on Stress- and Alcohol Cue-induced Craving in Alcohol Use Disorder

A Phase 2/3 study testing Oxytocin nasal spray and Naltrexone Pill in people with Alcohol Use Disorder and Alcoholism, run by Central Institute of Mental Health, Mannheim at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Alcohol Use Disorder, Alcoholism, Alcohol Addiction
What is being tested?: Oxytocin nasal spray and Naltrexone Pill
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 62 participants
Where: 1 siteGermany
Study dates: 2 Dec 2021to 27 Sep 2023
Phase: Phase 2/3
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 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age between 18 and 70 years
Patients meeting the diagnosis of an alcohol dependence according to the Internation Clasification of Diseases 10th revision (ICD10)
Patients with at least moderate craving, i.e. either >=15 points on the Alcohol Urge Questionnaire (AUQ, range 8 to 56 points) craving scale or increase in AUQ scores by >= 50% after exposure to visual alcohol cues (i.e. minimum increase of >=4 points after cue exposure)
Ability of the individual to understand the character and the individual consequences of the clinical trial
Written informed consent (must be available before enrollment in the study)
Consent to random assignment
For women with childbearing potential, use of a highly effective birth control method until 24 hours after Visit 4 and negative pregnancy test

Who cannot join

Subjects presenting with any of the following criteria will not be included in the clinical trial: Current psychotic or bipolar disorder or current severe depressive episode with suicidal ideations
Current treatment with any of the following substances: Any investigational medicinal product, Opioid-containing Analgesics, Anorexics, Anticonvulsants, Opioid-containing Antidiarrheal Agents, Antineoplastics, Antipsychotics (exception: episodic use of melperone, pipamperone and quetiapine are allowed), Antidepressants (exception: allowed, when being taken in stable dose for a minimum of 14 days prior to enrolment and/or doxepin in low doses [max. 75mg daily]), Opioid-containing Cough/cold agents, systemic Steroids
Positive drug screening (amphetamines/ecstasy, opiates, cocaine, barbiturates)
Pregnancy, lactation or breastfeeding
Current severe somatic comorbidities: liver cirrhosis [CHILD B or C] or impaired renal function [glomerular filtration rate (GFR)<15ml/Min] [each determined by physical examination and/or laboratory testing], severe heart insufficiency [determined by assessment of medical history], pre-existing epilepsy [determined by assessment of medical history], long-QT syndrome or cardial arrhythmia [determined by ECG]
History of hypersensitivity to the investigational medicinal product Oxytocin (Syntocinon®) and/or Naltrexone (trade names: Adepend, Naltrexon-Hcl neuraxpharm, Naltrexonhydrochlorid Accord) or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product Oxytocin (Syntocinon®) and/or Naltrexone
Participation in other clinical trials or observation period of competing clinical trials, respectively.
Acute suicidal tendency or acute endangerment of self and others

Trial locations and contacts

1 site in 1 country.

Germany1 site

Central Institute of Mental Health
Mannheim, 68159

Other trials in Germany

About this study

Official title: Oxytocin and Naltrexone: Investigation of Combined Effects on Stress- and Alcohol Cue-induced Craving in Alcohol Use Disorder - a Randomized Double-blind Placebo-controlled Parallel-group Trial

Alcohol use disorder (AUD) is a chronic relapsing disorder. Alcohol craving, a hallmark symptom of AUD that drives relapse in patients, is only insufficiently treated by existing medication. One promising new compound is Oxytocin (OXY), which showed beneficial effects on alcohol craving in preliminary clinical studies. Additionally, OXY seems to enhance effects of established medication, specifically Naltrexone (NTX), an opioid-antagonist which is approved for AUD treatment via positive synergism on neurotransmitter levels. The proposed two-armed, 1:1 randomized, double-blind, parallel group trial seeks to test the putative synergistic effects of combined intranasal OXY spray (24 IU) + oral NTX (50mg) against Placebo spray + oral NTX (50mg) on alcohol craving (primary outcome) in male and female patients with AUD that suffer from high alcohol craving, within the framework of a validated alcohol cue-and stress-exposure task (i.e. a combined Trier Stress Test and alcohol cue-exposure) that was established for screening new medications in AUD and determine their effects on craving and relapse risk. Treatment effects on additional neurobiological and biochemical markers of craving that show strong associations to individual relapse risk, will serve as secondary outcomes. Collection and analysis of follow-up data (90 days) will be performed to determine whether treatment effects relate to patient outcome.

The clinical trial period for an individual participant consists of a screening visit (visit 1), a baseline visit (visit 2) and two treatment visits (visits 3 and 4)(all within equal or less than ten days) followed by a 90 days (+/- 7 days) follow-up phase with two visits (visits 5 and 6) at day 30 (± 7 days) and day 90 (± 7 days). Visits 1 to 4 will be conducted while participants are undergoing standard in-patient treatment at the Department of Addictive Behavior and Addiction medicine at the Central Institute of Mental Health (CIMH) in Mannheim, Germany, for the medical condition under investigation.

Conditions: Alcohol Use Disorder, Alcoholism, Alcohol Addiction
Being tested: Oxytocin nasal spray, Naltrexone Pill, Placebo
Medical subject headings: Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Oxytocin nasal sprayDrug
24 I.U. Oxytocin nasal Spray will be administered twice on two separate trial days.
Naltrexone PillDrug
All participants will receive 50mg Naltrexone daily as oral tablet throughout the study
PlaceboDrug
Placebo nasal spray (same composition as the verum oxytocin spray except for the active ingredient oxytocin)

Study groups in NCT05093296
Study group	Role	What they receive
Oxytocin + Naltrexone	Experimental	All patients will receive 50mg Naltrexone daily (NTX, oral tablet) in the course of standard in-patient treatment. In the experimental group, patients will receive a single dose of 24 I.U. oxytocin nasal spray at two study visits during in-patient treatment: * Visit 2 - First Application of Oxytocin 40 minutes prior to a combined stress- and alcohol cue-exposure during visit 2 * Visit 3 - Second Application of Oxytocin 40 minutes prior to an fMRI-based assessment of alcohol cue-reactivity Receives: Drug: Oxytocin nasal spray; Drug: Naltrexone Pill
Placebo + Naltrexone	Active comparator	All patients will receive 50mg Naltrexone daily (NTX, oral tablet) in the course of standard in-patient treatment. In the comparator group, patients will receive a placebo nasal spray (same composition as the verum oxytocin spray except for the active ingredient oxytocin) at two study visits during in-patient treatment: * Visit 2 - First Application of Placebo 40 minutes prior to a combined stress- and alcohol cue-exposure during visit 2 * Visit 3 - Second Application of Placebo 40 minutes prior to an fMRI-based assessment of alcohol cue-reactivity Receives: Drug: Naltrexone Pill; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Alcohol Urge Questionnaire (AUQ)
Subjective Alcohol Craving will be assessed at separate time points before and after Oxytocin Administration using the AUQ
Measured: 60 minutes after oxytocin/placebo application and directly after the combined stress- and cue-exposure will serve as primary outcome measure at Visit 3

Secondary outcomes (24)

Alcohol Urge Questionnaire (AUQ)
Subjective Alcohol Craving will be assessed at separate time points before and after Oxytocin Administration using the AUQ
Measured: 35 minutes after oxytocin/placebo application at Visit 3
Alcohol Urge Questionnaire (AUQ)
Subjective Alcohol Craving will be assessed at separate time points before and after Oxytocin Administration using the AUQ
Measured: 70 minutes after oxytocin/placebo application at Visit 3
Alcohol Urge Questionnaire (AUQ)
Subjective Alcohol Craving will be assessed at separate time points before and after Oxytocin Administration using the AUQ
Measured: 80 minutes after oxytocin/placebo application at Visit 3
Alcohol Urge Questionnaire (AUQ)
Subjective Alcohol Craving will be assessed at separate time points before and after Oxytocin Administration using the AUQ
Measured: 90 minutes after oxytocin/placebo application at Visit 3
Alcohol Urge Questionnaire (AUQ)
Subjective Alcohol Craving will be assessed at separate time points before and after Oxytocin Administration using the AUQ
Measured: 85 minutes after oxytocin/placebo application, i.e. directly fMRI session at Visit 4
Primary Appraisal secondary Appraisal Scale (PASA)
Perceived stress will be assessed using the Primary Appraisal secondary Appraisal Scale (PASA) at separate time points before and after Oxytocin Administration using the AUQ at Visit 3 and Visit 4
Measured: 35 minutes after oxytocin/placebo application at Visit 3
Primary Appraisal secondary Appraisal Scale (PASA)
Perceived stress will be assessed using the Primary Appraisal secondary Appraisal Scale (PASA) at separate time points before and after Oxytocin Administration using the AUQ at Visit 3 and Visit 4
Measured: 60 minutes after oxytocin/placebo application at Visit 3
Primary Appraisal secondary Appraisal Scale (PASA)
Perceived stress will be assessed using the Primary Appraisal secondary Appraisal Scale (PASA) at separate time points before and after Oxytocin Administration using the AUQ at Visit 3 and Visit 4
Measured: 90 minutes after oxytocin/placebo application at Visit 3
Primary Appraisal secondary Appraisal Scale (PASA)
Perceived stress will be assessed using the Primary Appraisal secondary Appraisal Scale (PASA) at separate time points before and after Oxytocin Administration using the AUQ at Visit 3 and Visit 4
Measured: 85 minutes after oxytocin/placebo application, i.e. directly fMRI session at Visit 4
Positive and Negative Affect Schedule (PANAS)
Positive and Negative Affect will be assessed using the Positive and Negative Affect Schedule (PANAS) at separate time points before and after Oxytocin Administration using the AUQ at Visit 3 and Visit 4
Measured: 60 minutes after oxytocin/placebo application at Visit 3
Positive and Negative Affect Schedule (PANAS)
Positive and Negative Affect will be assessed using the Positive and Negative Affect Schedule (PANAS) at separate time points before and after Oxytocin Administration using the AUQ at Visit 3 and Visit 4
Measured: 85 minutes after oxytocin/placebo application, i.e. directly fMRI session at Visit 4
Cortisol
Cortisol plasma levels will be determined using validated Enzyme-linked Immunosorbent Assay (ELISA) methods by the central laboratory at visit 3 after Oxytocin/Placebo administration
Measured: 65 minutes after oxytocin/placebo application at Visit 3
Oxytocin
Oxytocin plasma levels will be determined using validated ELISA methods by the central laboratory at visit 3 after Oxytocin/Placebo administration
Measured: 30 minutes after oxytocin/placebo application at Visit 3
Oxytocin
Oxytocin plasma levels will be determined using validated ELISA methods by the central laboratory at visit 3 after Oxytocin/Placebo administration
Measured: 65 minutes after oxytocin/placebo application at Visit 3
Alcohol Cue-induced neural brain activation during an Alcohol cue-reactivity functional magnetic resonance imaging (fMRI) task
Neural brain activation in the mesocorticolimbic system (whole-brain and Region-of-Interest Analyses (ROIs): ventral striatum, dorsal striatum, insula), measured using the blood oxygenated level dependent (BOLD) response, during presentation of alcohol cues will serve as secondary outcome
Measured: During fMRI session at Visit 4, i.e. 40 to 85 minutes after Oxytocin/Placebo administration
Neural Activation during a natural reward cue-reactivity fMRI task
Neural brain activation in the mesocorticolimbic system (whole-brain and ROIs: ventral striatum, dorsal striatum, insula), measured using the blood oxygenated level dependent (BOLD) response during the presentation of natural reward cues will serve as secondary outcome
Measured: During fMRI session at Visit 4, i.e. 40 to 85 minutes after Oxytocin/Placebo administration
Neural Activation during a Face-matching fMRI task
Neural brain activation in the mesocorticolimbic system (whole-brain and ROIs: ventral striatum, dorsal striatum, insula, amygdala), measured using the blood oxygenated level dependent (BOLD) response during the presentation of emotional faces and neutral shapes will serve as secondary outcome
Measured: During fMRI session at Visit 4, i.e. 40 to 85 minutes after Oxytocin/Placebo administration
Neural Activation during a Stop Signal fMRI Task
Neural brain activation in the mesocorticolimbic system (whole-brain and ROIs: ventral striatum, dorsal striatum, insula, dlPFC), measured using the blood oxygenated level dependent (BOLD) response during a stop signal fMRI task will serve as secondary outcome
Measured: During fMRI session at Visit 4, i.e. 40 to 85 minutes after Oxytocin/Placebo administration
Adverse Events (AEs)/Serious Adverse Events (SAEs) and Discontinuation rate
Rate of adverse events, serious adverse events and rate of discontinuation of the study due to an adverse event
Measured: During Study Visits 1 to 6, including the 90 day (±7 day) follow-up period
Subjective quality of life index
Quality of life will be assessed using the WHO-QOL-BREF scores
Measured: At Visit 5, i.e. 30 days (+/- 7 days) after Visit 3
Subjective quality of life index
Quality of life will be assessed using the World Health Organization (WHO) Quality of life assessment (WHO-QOL-BREF) scores
Measured: At Visit 6, i.e. 90 days (+/- 7 days) after Visit 3
Time to relapse during the follow-up period of 90 days (+/- 7 days)
Time from randomization to relapse to alcohol use (in days)
Measured: During 90-day (± 7 days) Follow-up
Cumulative alcohol consumption during the follow-up period of 90 days (+/- 7 days)
Self-reported cumulative alcohol use (in gram)
Measured: During 90-day (± 7 days) Follow-up
Percent heavy drinking days during the follow-up period of 90 days (+/- 7 days)
Self-reported percent heavy drinking days (in %)
Measured: During 90-day (± 7 days) Follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Dec 202127 Sep 2023

First posted26 Oct 2021
Study start2 Dec 2021
Primary completion15 Jul 2023
Study completion27 Sep 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 62 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05093296
Sponsor's protocol ID: CIMH ON-ICE 21
Acronym: ON-ICE
Status last verified: Mar 2024
First submitted: 13 Oct 2021
Last updated: 29 Mar 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Individual de-identified data will be shared, specifically individual participant data that underlie the results of the trial (i.e. primary outcome data \[AUQ scores\]) will be made available with a respective data dictionary. Secondary Outcome data (e.g. fMRI data) will be made available on aggregated group level (e.g. for the purpose of meta-analyses). Related documents, specifically the study protocol, statistical analysis plan and analytic code will be shared in open-access online repositories. Aggregated data will be made available to publicly accessible repositories (Neurosynth.org), e.g. for the purpose of meta-analyses.

Publications

Zimmermann S, Thomas BC, Krisam J, Limprecht R, Klose C, Stenger M, Pourbaix M, Ries M, Vollstaedt-Klein S, Koopmann A, Lenz B, Kiefer F, Bach P. ON-ICE trial: Investigation of the combined effects of oxytocin and naltrexone on stress-induced and alcohol cue-induced craving in alcohol use disorder-Study protocol of a phase II randomised double-blind placebo-controlled parallel-group trial. BMJ Open. 2022 Apr 11;12(4):e059672. doi: 10.1136/bmjopen-2021-059672.
PubMed 35410938

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Alcohol Use Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Oxytocin and Naltrexone: Investigation of Combined Effects on Stress- and Alcohol Cue-induced Craving in Alcohol Use Disorder - a Randomized Double-blind Placebo-controlled Parallel-group Trial
ClinicalTrials.gov ID: NCT05093296
Acronym / sponsor ID: ON-ICE / CIMH ON-ICE 21
Conditions: Alcohol Use Disorder, Alcoholism, Alcohol Addiction
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 62 participants (actual)
Lead sponsor: Central Institute of Mental Health, MannheimUniversity, hospital or other
Collaborators: Heidelberg University, Heinrich-Heine University, Duesseldorf, German Federal Ministry of Education and Research
Study start: 2 Dec 2021 (actual)
Primary completion: 15 Jul 2023 (actual)
Study completion: 27 Sep 2023 (actual)
First posted: 26 Oct 2021 (actual)
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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Oxytocin + Naltrexone	Experimental	Drug: Oxytocin nasal spray, Drug: Naltrexone PillAll patients will receive 50mg Naltrexone daily (NTX, oral tablet) in the course of standard in-patient treatment. In the experimental group, patients will receive a single dose of 24 I.U. oxytocin nasal spray at two study visits during in-patient treatment: * Visit 2 - First Application of Oxytocin 40 minutes prior to a combined stress- and alcohol cue-exposure during visit 2 * Visit 3 - Second Application of Oxytocin 40 minutes prior to an fMRI-based assessment of alcohol cue-reactivity
Placebo + Naltrexone	Active comparator	Drug: Naltrexone Pill, Drug: PlaceboAll patients will receive 50mg Naltrexone daily (NTX, oral tablet) in the course of standard in-patient treatment. In the comparator group, patients will receive a placebo nasal spray (same composition as the verum oxytocin spray except for the active ingredient oxytocin) at two study visits during in-patient treatment: * Visit 2 - First Application of Placebo 40 minutes prior to a combined stress- and alcohol cue-exposure during visit 2 * Visit 3 - Second Application of Placebo 40 minutes prior to an fMRI-based assessment of alcohol cue-reactivity

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Age between 18 and 70 years
Patients meeting the diagnosis of an alcohol dependence according to the Internation Clasification of Diseases 10th revision (ICD10)
Patients with at least moderate craving, i.e. either >=15 points on the Alcohol Urge Questionnaire (AUQ, range 8 to 56 points) craving scale or increase in AUQ scores by >= 50% after exposure to visual alcohol cues (i.e. minimum increase of >=4 points after cue exposure)
Ability of the individual to understand the character and the individual consequences of the clinical trial
Written informed consent (must be available before enrollment in the study)

Key exclusion criteria (8 listed)

Subjects presenting with any of the following criteria will not be included in the clinical trial: Current psychotic or bipolar disorder or current severe depressive episode with suicidal ideations
Current treatment with any of the following substances: Any investigational medicinal product, Opioid-containing Analgesics, Anorexics, Anticonvulsants, Opioid-containing Antidiarrheal Agents, Antineoplastics, Antipsychotics (exception: episodic use of melperone, pipamperone and quetiapine are allowed), Antidepressants (exception: allowed, when being taken in stable dose for a minimum of 14 days prior to enrolment and/or doxepin in low doses [max. 75mg daily]), Opioid-containing Cough/cold agents, systemic Steroids
Positive drug screening (amphetamines/ecstasy, opiates, cocaine, barbiturates)
Pregnancy, lactation or breastfeeding
Current severe somatic comorbidities: liver cirrhosis [CHILD B or C] or impaired renal function [glomerular filtration rate (GFR)<15ml/Min] [each determined by physical examination and/or laboratory testing], severe heart insufficiency [determined by assessment of medical history], pre-existing epilepsy [determined by assessment of medical history], long-QT syndrome or cardial arrhythmia [determined by ECG]

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
Oxytocin nasal spray24 I.U. Oxytocin nasal Spray will be administered twice on two separate trial days.	Drug	Oxytocin + Naltrexone
Naltrexone PillAll participants will receive 50mg Naltrexone daily as oral tablet throughout the study	Drug	Oxytocin + Naltrexone, Placebo + Naltrexone
PlaceboPlacebo nasal spray (same composition as the verum oxytocin spray except for the active ingredient oxytocin)	Drug	Placebo + Naltrexone

Primary outcome

Alcohol Urge Questionnaire (AUQ)
Time frame: 60 minutes after oxytocin/placebo application and directly after the combined stress- and cue-exposure will serve as primary outcome measure at Visit 3
Subjective Alcohol Craving will be assessed at separate time points before and after Oxytocin Administration using the AUQ

24 secondary outcomes

Alcohol Urge Questionnaire (AUQ)
Time frame: 35 minutes after oxytocin/placebo application at Visit 3
Alcohol Urge Questionnaire (AUQ)
Time frame: 70 minutes after oxytocin/placebo application at Visit 3
Alcohol Urge Questionnaire (AUQ)
Time frame: 80 minutes after oxytocin/placebo application at Visit 3
Alcohol Urge Questionnaire (AUQ)
Time frame: 90 minutes after oxytocin/placebo application at Visit 3
Alcohol Urge Questionnaire (AUQ)
Time frame: 85 minutes after oxytocin/placebo application, i.e. directly fMRI session at Visit 4
Primary Appraisal secondary Appraisal Scale (PASA)
Time frame: 35 minutes after oxytocin/placebo application at Visit 3
Primary Appraisal secondary Appraisal Scale (PASA)
Time frame: 60 minutes after oxytocin/placebo application at Visit 3
Primary Appraisal secondary Appraisal Scale (PASA)
Time frame: 90 minutes after oxytocin/placebo application at Visit 3
Primary Appraisal secondary Appraisal Scale (PASA)
Time frame: 85 minutes after oxytocin/placebo application, i.e. directly fMRI session at Visit 4
Positive and Negative Affect Schedule (PANAS)
Time frame: 60 minutes after oxytocin/placebo application at Visit 3
Positive and Negative Affect Schedule (PANAS)
Time frame: 85 minutes after oxytocin/placebo application, i.e. directly fMRI session at Visit 4
Cortisol
Time frame: 65 minutes after oxytocin/placebo application at Visit 3
Oxytocin
Time frame: 30 minutes after oxytocin/placebo application at Visit 3
Oxytocin
Time frame: 65 minutes after oxytocin/placebo application at Visit 3
Alcohol Cue-induced neural brain activation during an Alcohol cue-reactivity functional magnetic resonance imaging (fMRI) task
Time frame: During fMRI session at Visit 4, i.e. 40 to 85 minutes after Oxytocin/Placebo administration
Neural Activation during a natural reward cue-reactivity fMRI task
Time frame: During fMRI session at Visit 4, i.e. 40 to 85 minutes after Oxytocin/Placebo administration
Neural Activation during a Face-matching fMRI task
Time frame: During fMRI session at Visit 4, i.e. 40 to 85 minutes after Oxytocin/Placebo administration
Neural Activation during a Stop Signal fMRI Task
Time frame: During fMRI session at Visit 4, i.e. 40 to 85 minutes after Oxytocin/Placebo administration
Adverse Events (AEs)/Serious Adverse Events (SAEs) and Discontinuation rate
Time frame: During Study Visits 1 to 6, including the 90 day (±7 day) follow-up period
Subjective quality of life index
Time frame: At Visit 5, i.e. 30 days (+/- 7 days) after Visit 3
Subjective quality of life index
Time frame: At Visit 6, i.e. 90 days (+/- 7 days) after Visit 3
Time to relapse during the follow-up period of 90 days (+/- 7 days)
Time frame: During 90-day (± 7 days) Follow-up
Cumulative alcohol consumption during the follow-up period of 90 days (+/- 7 days)
Time frame: During 90-day (± 7 days) Follow-up
Percent heavy drinking days during the follow-up period of 90 days (+/- 7 days)
Time frame: During 90-day (± 7 days) Follow-up

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 29 Mar 2024.
Derived from this study: PubMed 35410938Zimmermann S, Thomas BC, Krisam J, Limprecht R, Klose C, Stenger M, Pourbaix M, Ries M, Vollstaedt-Klein S, Koopmann A, Lenz B, Kiefer F, Bach P. ON-ICE trial: Investigation of the combined effects of oxytocin and naltrexone on stress-induced and alcohol cue-induced craving in alcohol use disorder-Study protocol of a phase II randomised double-blind placebo-controlled parallel-group trial. BMJ Open. 2022 Apr 11;12(4):e059672. doi: 10.1136/bmjopen-2021-059672.
Individual participant dataSharing planned: Yes. Individual de-identified data will be shared, specifically individual participant data that underlie the results of the trial (i.e. primary outcome data [AUQ scores]) will be made available with a respective data dictionary. Secondary Outcome data (e.g. fMRI data) will be made available on aggregated group level (e.g. for the purpose of meta-analyses). Related documents, specifically the study protocol, statistical analysis plan and analytic code will be shared in open-access online repositories. Aggregated data will be made available to publicly accessible repositories (Neurosynth.org), e.g. for the purpose of meta-analyses.

Related trials for Alcohol Use Disorder

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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.

Patrick Bach, MD study director

Central Institute of Mental Health, Mannheim

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Oxytocin nasal spray and Naltrexone Pill in people with Alcohol Use Disorder and Alcoholism, run by Central Institute of Mental Health, Mannheim at 1 site in Germany.

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 7 inclusion and 8 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 29 Mar 2024. 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 Germany. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Alcohol Urge Questionnaire (AUQ) (time frame: 60 minutes after oxytocin/placebo application and directly after the combined stress- and cue-exposure will serve as primary outcome measure at Visit 3). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05093296, which also lists 1 linked publication.

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 29 Mar 2024.