search
Back to results

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

Primary Purpose

Alcohol Use Disorder, Alcoholism, Alcohol Addiction

Status
Recruiting
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Oxytocin nasal spray
Naltrexone Pill
Placebo
Sponsored by
Central Institute of Mental Health, Mannheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use Disorder

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Central Institute of Mental HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Oxytocin + Naltrexone

Placebo + Naltrexone

Arm Description

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

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

Outcomes

Primary Outcome Measures

Alcohol Urge Questionnaire (AUQ)
Subjective Alcohol Craving will be assessed at separate time points before and after Oxytocin Administration using the AUQ

Secondary Outcome Measures

Alcohol Urge Questionnaire (AUQ)
Subjective Alcohol Craving will be assessed at separate time points before and after Oxytocin Administration using the AUQ
Alcohol Urge Questionnaire (AUQ)
Subjective Alcohol Craving will be assessed at separate time points before and after Oxytocin Administration using the AUQ
Alcohol Urge Questionnaire (AUQ)
Subjective Alcohol Craving will be assessed at separate time points before and after Oxytocin Administration using the AUQ
Alcohol Urge Questionnaire (AUQ)
Subjective Alcohol Craving will be assessed at separate time points before and after Oxytocin Administration using the AUQ
Alcohol Urge Questionnaire (AUQ)
Subjective Alcohol Craving will be assessed at separate time points before and after Oxytocin Administration using the AUQ
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
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
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
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
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
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
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
Oxytocin
Oxytocin plasma levels will be determined using validated ELISA methods by the central laboratory at visit 3 after Oxytocin/Placebo administration
Oxytocin
Oxytocin plasma levels will be determined using validated ELISA methods by the central laboratory at visit 3 after Oxytocin/Placebo administration
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
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
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
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
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
Subjective quality of life index
Quality of life will be assessed using the WHO-QOL-BREF scores
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
Time to relapse during the follow-up period of 90 days (+/- 7 days)
Time from randomization to relapse to alcohol use (in days)
Cumulative alcohol consumption during the follow-up period of 90 days (+/- 7 days)
Self-reported cumulative alcohol use (in gram)
Percent heavy drinking days during the follow-up period of 90 days (+/- 7 days)
Self-reported percent heavy drinking days (in %)

Full Information

First Posted
October 13, 2021
Last Updated
March 30, 2023
Sponsor
Central Institute of Mental Health, Mannheim
Collaborators
Heidelberg University - Institute of Medical Biometry (IMBI), Heidelberg University - Coordination Centre for Clinical Trials (KKS) of Heidelberg University, German Federal Ministry of Education and Research
search

1. Study Identification

Unique Protocol Identification Number
NCT05093296
Brief Title
Oxytocin and Naltrexone: Investigation of Combined Effects on Stress- and Alcohol Cue-induced Craving in Alcohol Use Disorder
Acronym
ON-ICE
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 2, 2021 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Institute of Mental Health, Mannheim
Collaborators
Heidelberg University - Institute of Medical Biometry (IMBI), Heidelberg University - Coordination Centre for Clinical Trials (KKS) of Heidelberg University, German Federal Ministry of Education and Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder, Alcoholism, Alcohol Addiction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oxytocin + Naltrexone
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo + Naltrexone
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Oxytocin nasal spray
Intervention Description
24 I.U. Oxytocin nasal Spray will be administered twice on two separate trial days.
Intervention Type
Drug
Intervention Name(s)
Naltrexone Pill
Intervention Description
All participants will receive 50mg Naltrexone daily as oral tablet throughout the study
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo nasal spray (same composition as the verum oxytocin spray except for the active ingredient oxytocin)
Primary Outcome Measure Information:
Title
Alcohol Urge Questionnaire (AUQ)
Description
Subjective Alcohol Craving will be assessed at separate time points before and after Oxytocin Administration using the 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
Secondary Outcome Measure Information:
Title
Alcohol Urge Questionnaire (AUQ)
Description
Subjective Alcohol Craving will be assessed at separate time points before and after Oxytocin Administration using the AUQ
Time Frame
35 minutes after oxytocin/placebo application at Visit 3
Title
Alcohol Urge Questionnaire (AUQ)
Description
Subjective Alcohol Craving will be assessed at separate time points before and after Oxytocin Administration using the AUQ
Time Frame
70 minutes after oxytocin/placebo application at Visit 3
Title
Alcohol Urge Questionnaire (AUQ)
Description
Subjective Alcohol Craving will be assessed at separate time points before and after Oxytocin Administration using the AUQ
Time Frame
80 minutes after oxytocin/placebo application at Visit 3
Title
Alcohol Urge Questionnaire (AUQ)
Description
Subjective Alcohol Craving will be assessed at separate time points before and after Oxytocin Administration using the AUQ
Time Frame
90 minutes after oxytocin/placebo application at Visit 3
Title
Alcohol Urge Questionnaire (AUQ)
Description
Subjective Alcohol Craving will be assessed at separate time points before and after Oxytocin Administration using the AUQ
Time Frame
85 minutes after oxytocin/placebo application, i.e. directly fMRI session at Visit 4
Title
Primary Appraisal secondary Appraisal Scale (PASA)
Description
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
Time Frame
35 minutes after oxytocin/placebo application at Visit 3
Title
Primary Appraisal secondary Appraisal Scale (PASA)
Description
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
Time Frame
60 minutes after oxytocin/placebo application at Visit 3
Title
Primary Appraisal secondary Appraisal Scale (PASA)
Description
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
Time Frame
90 minutes after oxytocin/placebo application at Visit 3
Title
Primary Appraisal secondary Appraisal Scale (PASA)
Description
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
Time Frame
85 minutes after oxytocin/placebo application, i.e. directly fMRI session at Visit 4
Title
Positive and Negative Affect Schedule (PANAS)
Description
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
Time Frame
60 minutes after oxytocin/placebo application at Visit 3
Title
Positive and Negative Affect Schedule (PANAS)
Description
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
Time Frame
85 minutes after oxytocin/placebo application, i.e. directly fMRI session at Visit 4
Title
Cortisol
Description
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
Time Frame
65 minutes after oxytocin/placebo application at Visit 3
Title
Oxytocin
Description
Oxytocin plasma levels will be determined using validated ELISA methods by the central laboratory at visit 3 after Oxytocin/Placebo administration
Time Frame
30 minutes after oxytocin/placebo application at Visit 3
Title
Oxytocin
Description
Oxytocin plasma levels will be determined using validated ELISA methods by the central laboratory at visit 3 after Oxytocin/Placebo administration
Time Frame
65 minutes after oxytocin/placebo application at Visit 3
Title
Alcohol Cue-induced neural brain activation during an Alcohol cue-reactivity functional magnetic resonance imaging (fMRI) task
Description
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
Time Frame
During fMRI session at Visit 4, i.e. 40 to 85 minutes after Oxytocin/Placebo administration
Title
Neural Activation during a natural reward cue-reactivity fMRI task
Description
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
Time Frame
During fMRI session at Visit 4, i.e. 40 to 85 minutes after Oxytocin/Placebo administration
Title
Neural Activation during a Face-matching fMRI task
Description
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
Time Frame
During fMRI session at Visit 4, i.e. 40 to 85 minutes after Oxytocin/Placebo administration
Title
Neural Activation during a Stop Signal fMRI Task
Description
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
Time Frame
During fMRI session at Visit 4, i.e. 40 to 85 minutes after Oxytocin/Placebo administration
Title
Adverse Events (AEs)/Serious Adverse Events (SAEs) and Discontinuation rate
Description
Rate of adverse events, serious adverse events and rate of discontinuation of the study due to an adverse event
Time Frame
During Study Visits 1 to 6, including the 90 day (±7 day) follow-up period
Title
Subjective quality of life index
Description
Quality of life will be assessed using the WHO-QOL-BREF scores
Time Frame
At Visit 5, i.e. 30 days (+/- 7 days) after Visit 3
Title
Subjective quality of life index
Description
Quality of life will be assessed using the World Health Organization (WHO) Quality of life assessment (WHO-QOL-BREF) scores
Time Frame
At Visit 6, i.e. 90 days (+/- 7 days) after Visit 3
Title
Time to relapse during the follow-up period of 90 days (+/- 7 days)
Description
Time from randomization to relapse to alcohol use (in days)
Time Frame
During 90-day (± 7 days) Follow-up
Title
Cumulative alcohol consumption during the follow-up period of 90 days (+/- 7 days)
Description
Self-reported cumulative alcohol use (in gram)
Time Frame
During 90-day (± 7 days) Follow-up
Title
Percent heavy drinking days during the follow-up period of 90 days (+/- 7 days)
Description
Self-reported percent heavy drinking days (in %)
Time Frame
During 90-day (± 7 days) Follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick Bach, MD
Phone
+49-621-1703-0
Email
patrick.bach@zi-mannheim.de
First Name & Middle Initial & Last Name or Official Title & Degree
Sina Zimmermann, M.Sc.
Phone
+49-621-1703-0
Email
sina.zimmermann@zi-mannheim.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Bach, MD
Organizational Affiliation
Central Institute of Mental Health, Mannheim
Official's Role
Study Director
Facility Information:
Facility Name
Central Institute of Mental Health
City
Mannheim
ZIP/Postal Code
68159
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick Bach, MD
Phone
+496211703
Ext
0
Email
patrick.bach@zi-mannheim.de
First Name & Middle Initial & Last Name & Degree
Sina Zimmermann, M.Sc.
Phone
+496211703
Ext
0
Email
sina.zimmermann@zi-mannheim.de
First Name & Middle Initial & Last Name & Degree
Patrick Bach, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Data will be available upon publication of the results until 3 years after that.
IPD Sharing Access Criteria
Individual data will be shared with researchers who provide a methodologically sound proposal (sent to the Principal Investigator/Study Chair of the Trial).
Citations:
PubMed Identifier
35410938
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs