Heavy DrinkingTEDDS_OCRTNCT05189379

Targeted Extinction of Drug Cues During Sleep - Olfactory Cue Reactivity Task

A study testing Non-Alcoholic Odour, Alcoholic Odour and Non-Alcoholic Images in people with Heavy Drinking, 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 65 years
Conditions the study is for: Heavy Drinking
What is being tested?: Non-Alcoholic Odour, Alcoholic Odour and Non-Alcoholic Images
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 46 participants
Where: 1 siteGermany
Study dates: 10 Mar 2022to 25 May 2023
Phase: Interventional
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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

An Heavy Drinking diagnosis, confirmed by Alcohol Use Disorders Identification Test
Ability to provide fully informed consent and to use self-rating scales in fMRI
Understanding of the German language

Who cannot join

Severe mental or physical illnesses
Insomnia
Any metal parts and pieces in the body
Claustrophobia; fear of confined spaces

Trial locations and contacts

1 site in 1 country.

Germany1 site

Zentralinstitut für Seelische Gesundheit Mannheim
Mannheim, Baden-Wurttemberg, 68159

Other trials in Germany

About this study

The study aims to utilise olfactory stimulation in addition to the visual stimulation in cue reactivity tasks to enhance precision in measuring alcohol based cues in individuals diagnosed with heavy drinking. The study consists of one cue reactivity task with visual stimuli, another cue reactivity task with matching odour/visual stimuli and lastly a monetary incentive delay task.

Read the detailed description

The intention of the study is to enhance the measurement precision in image-based cue reactivity task by introducing a new level of stimuli in the form of odours. During the course of the functional Magnetic Resonance Imaging (fMRI) screening, participants are required to finish three tasks, namely; odour-based cue reactivity task (OCRT), image-based cue reactivity task(ICRT) and monetary incentive delay task (MID).

Participants will be randomly divided into two groups, one group will receive tasks in the following order: OCRT-MID-ICRT and the other group will receive them in the following order: ICRT-MID-OCRT. With this, the habituation effect from receiving odours during OCRT is expected to be balanced.

Conditions: Heavy Drinking
Being tested: Non-Alcoholic Odour, Alcoholic Odour, Non-Alcoholic Images, Alcoholic Images
Keywords: Cue Reactivity Task, Heavy Drinking, Olfactory Cue Reactivity Task

What participants receive

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

Non-Alcoholic OdourOther
Also called Coffee furanone, 2-Methyltetrahydrofuran-3-one
A chemical used in fragrances and flavouring with a smell close to a nutty, buttery structure. Used as a 1:100 deionised water dilution.
Alcoholic OdourOther
Also called Beer, Wine, Schnapps
Alcoholic beverage beer / Alcoholic beverage red wine / Alcoholic beverage brandy / The type of the Alcoholic Odour intervention will be presented in a participant-preference basis.
Non-Alcoholic ImagesOther
Images of non-alcoholic items, namely; broom, duster, clothing iron, lightbulb, mat, mulch, penlight, rack, rock, kitchen scissors, trough, vent are presented in parallel with the non-alcoholic odour
Alcoholic ImagesOther
Images of alcoholic items, namely, beer, wine, schnapps are presented in parallel with the alcoholic odour

Study groups in NCT05189379
Study group	Role	What they receive
Olfaction First	Experimental	Participants assigned to this arm will undergo the experiment in the following order: Odour based Cue Reactivity Task, Monetary Incentive Delay Task, Image based Cue Reactivity Task Receives: Other: Non-Alcoholic Odour; Other: Alcoholic Odour; Other: Non-Alcoholic Images; Other: Alcoholic Images
Image First	Experimental	Participants assigned to this arm will undergo the experiment in the following order: Image based Cue Reactivity Task, Monetary Incentive Delay Task, Odour based Cue Reactivity Task Receives: Other: Non-Alcoholic Odour; Other: Alcoholic Odour; Other: Non-Alcoholic Images; Other: Alcoholic Images

What is being measured

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

Change in Blood Oxygen Level Dependent (BOLD) signal within selected Regions of Interest (ROI)
Change in brain activation in the form of BOLD signals within 3 groups of ROIs:
- Memory related ROIs: Hippocampus, Dorsolateral Prefrontal Cortex
- Cognitive Control related ROIs: Anterior Cingulate Cortex, Ventrolateral Prefrontal Cortex
- Reward related ROIs: Striatum (ventral and dorsal) and Insula
Measured: Once during the fMRI experiment
Odour based cue reactivity task
A cue reactivity task based on the odours and images of alcoholic and non-alcoholic items. Adapted from Vollstädt-Klein et al., 2011.
Subjects are presented with odours and images of alcoholic (beer, wine, schnapps) and non-alcoholic (odour: 2-Methyltetrahydrofuran-3-one / images: broom, duster, clothing iron, lightbulb, mat, mulch, penlight, rack, rock, kitchen scissors, trough, vent) items during an fMRI session in blocks. For non-alcoholic items, in each block 5 images from the same stimuli group are presented with the non-alcoholic odour. For alcoholic items, in each block there are 5 images from the selected stimuli group with the congruent odour.
After each block subjects are asked to rate their liking and wanting towards the items that have been presented to them in two 1-5 scales. Blocks are pseudorandomised to maximise balance between groups and minimise the effect of habituation.
Minimum 1: "not at all", maximum 5: "very much".
Measured: Once during the fMRI screening
Image based cue reactivity task
A cue reactivity task based on the images of alcoholic and non-alcoholic items. Adapted from Vollstädt-Klein et al., 2011.
Subjects are presented with images of the alcoholic (beer, wine, schnapps) and the non-alcoholic (broom, duster, clothing iron, lightbulb, mat, mulch, penlight, rack, rock, kitchen scissors, trough, vent) items during an fMRI session in blocks. In each block there are 5 images from the same stimuli group. After each block subjects are asked to rate their liking and wanting towards the items that have been presented to them in two 1-5 scales. Blocks are pseudorandomised to maximise balance between groups and minimise the effect of habituation.
Minimum 1: "not at all", maximum 5: "very much".
Measured: Once during the fMRI screening
Monetary incentive delay task
A task to invoke reward based activations in the subjects. Adapted from Kirsch et al., 2003.
Subjects are presented 3 different stimulus conditions, each linked either to a positive monetary reward (a vertically oriented arrow pointing upward), a positive verbal feedback (a vertically oriented double-sided arrow) or a neutral no reward or feedback (a horizontally oriented double-sided arrow). After presentation of the two positive stimuli types, a flashing screen is presented and during the flashing screen if the subjects can press the button fast enough they will either win 1€ or they will be shown a positive verbal feedback depending on the positive stimuli type. The negative stimuli is followed by a 3 second black screen to include a control condition. Each stimulus condition is presented 10 times in a pseudorandom schedule with no more than two equal conditions in succession. The inter-trial interval randomly varies between 6-9 seconds.
Measured: Once during the fMRI screening

Secondary outcomes (4)

Psychomotor Vigilance Test (Roach et al. 2006)
Task measuring the objective vigilance of subjects. To distinguish vigilance between the wake and the sleep conditions, following measures will be compared: Median reaction speed (1/reaction time) and percentage of lapses (number of lapses divided by the number of all valid stimuli, excluding false starts. Lapse >= 500 ms, false start < 100ms). The task is prepared in JsPsych, and administered with using a tablet connected to internet. Participant data is securely stored in an encrypted server.
Measured: Once before the fMRI screening
Stanford Sleepiness Scale (Hoddes et al. 1973)
Test measuring current level of alertness of subjects on a seven point scale. A high test score indicates a high level of sleepiness and conversely a low test score yields a low level of sleepiness. Test scores will be utilized as a pre-measurement alertness indicator for participants. The task is prepared in JsPsych, and administered with using a tablet connected to internet. Participant data is securely stored in an encrypted server.
Measured: Once before the fMRI screening
Alcohol Urge Questionnaire (Bohn et al. 1995)
Questionnaire on self-assessment of current craving of subjects. Consists of 8 items on a Likert-type scale from 1-7 where higher scores represent stronger alcohol urges. The task is prepared in JsPsych, and administered with using a tablet connected to internet. Participant data is securely stored in an encrypted server.
Measured: Once before the fMRI screening
Sniffin' Sticks Test (Burghardt®, Wedel, Germany)(Hummel et al., 1997)
A psychophysical test that is developed for assessing individuals reactions to the olfactory stimuli (Hummel et al., 1997). The 12-stick test from Burghardt is chosen for the study and it consists of identifying one of the four items that are presented with each of the twelve odourant sticks. At the end, with the aid of the identification score, the participant's olfaction capability is assessed.
Measured: Once before the fMRI screening

Timeline

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

10 Mar 202225 May 2023

First posted12 Jan 2022
Study start10 Mar 2022
Primary completion25 May 2023
Study completion25 May 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Heavy DrinkingStudies 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 N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Model description: A two group study is constructed with the sole intention to balance the amount of participants who would undergo the same experiment with a different order. Half of the participants will receive odour based Cue Reactivity Task first, other half will complete the image based Cue Reactivity Task first. Before the MRI screening participants would be asked about their preference between beer, wine and schnapps then during the odour based Cue Reactivity Task only their preferred beverage odour would be delivered.
Masking: None (open label)
Enrolment: 46 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05189379
Sponsor's protocol ID: tedds_ocrt_1
Acronym: TEDDS_OCRT
Status last verified: Jan 2024
First submitted: 27 Dec 2021
Last updated: 31 Jan 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Due to data protection rules, individual data cannot be shared. Cumulated data on the group level can be made available for meta-analyses on request.

Publications

Vollstadt-Klein S, Loeber S, Kirsch M, Bach P, Richter A, Buhler M, von der Goltz C, Hermann D, Mann K, Kiefer F. Effects of cue-exposure treatment on neural cue reactivity in alcohol dependence: a randomized trial. Biol Psychiatry. 2011 Jun 1;69(11):1060-6. doi: 10.1016/j.biopsych.2010.12.016. Epub 2011 Feb 3.
PubMed 21292243
Roach GD, Dawson D, Lamond N. Can a shorter psychomotor vigilance task be used as a reasonable substitute for the ten-minute psychomotor vigilance task? Chronobiol Int. 2006;23(6):1379-87. doi: 10.1080/07420520601067931.
PubMed 17190720
Hoddes E, Zarcone V, Smythe H, Phillips R, Dement WC. Quantification of sleepiness: a new approach. Psychophysiology. 1973 Jul;10(4):431-6. doi: 10.1111/j.1469-8986.1973.tb00801.x. No abstract available.
PubMed 4719486
Bohn MJ, Krahn DD, Staehler BA. Development and initial validation of a measure of drinking urges in abstinent alcoholics. Alcohol Clin Exp Res. 1995 Jun;19(3):600-6. doi: 10.1111/j.1530-0277.1995.tb01554.x.
PubMed 7573780
Hummel T, Sekinger B, Wolf SR, Pauli E, Kobal G. 'Sniffin' sticks': olfactory performance assessed by the combined testing of odor identification, odor discrimination and olfactory threshold. Chem Senses. 1997 Feb;22(1):39-52. doi: 10.1093/chemse/22.1.39.
PubMed 9056084
Kirsch P, Schienle A, Stark R, Sammer G, Blecker C, Walter B, Ott U, Burkart J, Vaitl D. Anticipation of reward in a nonaversive differential conditioning paradigm and the brain reward system: an event-related fMRI study. Neuroimage. 2003 Oct;20(2):1086-95. doi: 10.1016/S1053-8119(03)00381-1.
PubMed 14568478

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?

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Study at a glance

From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Targeted Extinction of Drug Cues During Sleep - Olfactory Cue Reactivity Task
ClinicalTrials.gov ID: NCT05189379
Acronym / sponsor ID: TEDDS_OCRT / tedds_ocrt_1
Conditions: Heavy Drinking
Keywords: Cue Reactivity Task, Heavy Drinking, Olfactory Cue Reactivity Task
Study type: Interventional
Recruitment status: Completed
Enrolment: 46 participants (actual)
Lead sponsor: Central Institute of Mental Health, MannheimUniversity, hospital or other
Study start: 10 Mar 2022 (actual)
Primary completion: 25 May 2023 (actual)
Study completion: 25 May 2023 (actual)
First posted: 12 Jan 2022 (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.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: A two group study is constructed with the sole intention to balance the amount of participants who would undergo the same experiment with a different order. Half of the participants will receive odour based Cue Reactivity Task first, other half will complete the image based Cue Reactivity Task first. Before the MRI screening participants would be asked about their preference between beer, wine and schnapps then during the odour based Cue Reactivity Task only their preferred beverage odour would be delivered.

Arm	Type	Receives
Olfaction First	Experimental	Other: Non-Alcoholic Odour, Other: Alcoholic Odour, Other: Non-Alcoholic Images, Other: Alcoholic ImagesParticipants assigned to this arm will undergo the experiment in the following order: Odour based Cue Reactivity Task, Monetary Incentive Delay Task, Image based Cue Reactivity Task
Image First	Experimental	Other: Non-Alcoholic Odour, Other: Alcoholic Odour, Other: Non-Alcoholic Images, Other: Alcoholic ImagesParticipants assigned to this arm will undergo the experiment in the following order: Image based Cue Reactivity Task, Monetary Incentive Delay Task, Odour based Cue Reactivity Task

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

An Heavy Drinking diagnosis, confirmed by Alcohol Use Disorders Identification Test
Ability to provide fully informed consent and to use self-rating scales in fMRI
Understanding of the German language

Key exclusion criteria (4 listed)

Severe mental or physical illnesses
Insomnia
Any metal parts and pieces in the body
Claustrophobia; fear of confined spaces

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
Non-Alcoholic OdourAlso: Coffee furanone, 2-Methyltetrahydrofuran-3-oneA chemical used in fragrances and flavouring with a smell close to a nutty, buttery structure. Used as a 1:100 deionised water dilution.	Other	Image First, Olfaction First
Alcoholic OdourAlso: Beer, Wine, SchnappsAlcoholic beverage beer / Alcoholic beverage red wine / Alcoholic beverage brandy / The type of the Alcoholic Odour intervention will be presented in a participant-preference basis.	Other	Image First, Olfaction First
Non-Alcoholic ImagesImages of non-alcoholic items, namely; broom, duster, clothing iron, lightbulb, mat, mulch, penlight, rack, rock, kitchen scissors, trough, vent are presented in parallel with the non-alcoholic odour	Other	Image First, Olfaction First
Alcoholic ImagesImages of alcoholic items, namely, beer, wine, schnapps are presented in parallel with the alcoholic odour	Other	Image First, Olfaction First

Primary outcome

Change in Blood Oxygen Level Dependent (BOLD) signal within selected Regions of Interest (ROI)
Time frame: Once during the fMRI experiment
Change in brain activation in the form of BOLD signals within 3 groups of ROIs: * Memory related ROIs: Hippocampus, Dorsolateral Prefrontal Cortex * Cognitive Control related ROIs: Anterior Cingulate Cortex, Ventrolateral Prefrontal Cortex * Reward related ROIs: Striatum (ventral and dorsal) and Insula
Odour based cue reactivity task
Time frame: Once during the fMRI screening
A cue reactivity task based on the odours and images of alcoholic and non-alcoholic items. Adapted from Vollstädt-Klein et al., 2011. Subjects are presented with odours and images of alcoholic (beer, wine, schnapps) and non-alcoholic (odour: 2-Methyltetrahydrofuran-3-one / images: broom, duster, clothing iron, lightbulb, mat, mulch, penlight, rack, rock, kitchen scissors, trough, vent) items during an fMRI session in blocks. For non-alcoholic items, in each block 5 images from the same stimuli group are presented with the non-alcoholic odour. For alcoholic items, in each block there are 5 images from the selected stimuli group with the congruent odour. After each block subjects are asked to rate their liking and wanting towards the items that have been presented to them in two 1-5 scales. Blocks are pseudorandomised to maximise balance between groups and minimise the effect of habituation. Minimum 1: "not at all", maximum 5: "very much".
Image based cue reactivity task
Time frame: Once during the fMRI screening
A cue reactivity task based on the images of alcoholic and non-alcoholic items. Adapted from Vollstädt-Klein et al., 2011. Subjects are presented with images of the alcoholic (beer, wine, schnapps) and the non-alcoholic (broom, duster, clothing iron, lightbulb, mat, mulch, penlight, rack, rock, kitchen scissors, trough, vent) items during an fMRI session in blocks. In each block there are 5 images from the same stimuli group. After each block subjects are asked to rate their liking and wanting towards the items that have been presented to them in two 1-5 scales. Blocks are pseudorandomised to maximise balance between groups and minimise the effect of habituation. Minimum 1: "not at all", maximum 5: "very much".
Monetary incentive delay task
Time frame: Once during the fMRI screening
A task to invoke reward based activations in the subjects. Adapted from Kirsch et al., 2003. Subjects are presented 3 different stimulus conditions, each linked either to a positive monetary reward (a vertically oriented arrow pointing upward), a positive verbal feedback (a vertically oriented double-sided arrow) or a neutral no reward or feedback (a horizontally oriented double-sided arrow). After presentation of the two positive stimuli types, a flashing screen is presented and during the flashing screen if the subjects can press the button fast enough they will either win 1€ or they will be shown a positive verbal feedback depending on the positive stimuli type. The negative stimuli is followed by a 3 second black screen to include a control condition. Each stimulus condition is presented 10 times in a pseudorandom schedule with no more than two equal conditions in succession. The inter-trial interval randomly varies between 6-9 seconds.

4 secondary outcomes

Psychomotor Vigilance Test (Roach et al. 2006)
Time frame: Once before the fMRI screening
Stanford Sleepiness Scale (Hoddes et al. 1973)
Time frame: Once before the fMRI screening
Alcohol Urge Questionnaire (Bohn et al. 1995)
Time frame: Once before the fMRI screening
Sniffin' Sticks Test (Burghardt®, Wedel, Germany)(Hummel et al., 1997)
Time frame: Once before the fMRI screening

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 31 Jan 2024.
Background: PubMed 21292243Vollstadt-Klein S, Loeber S, Kirsch M, Bach P, Richter A, Buhler M, von der Goltz C, Hermann D, Mann K, Kiefer F. Effects of cue-exposure treatment on neural cue reactivity in alcohol dependence: a randomized trial. Biol Psychiatry. 2011 Jun 1;69(11):1060-6. doi: 10.1016/j.biopsych.2010.12.016. Epub 2011 Feb 3.
Background: PubMed 17190720Roach GD, Dawson D, Lamond N. Can a shorter psychomotor vigilance task be used as a reasonable substitute for the ten-minute psychomotor vigilance task? Chronobiol Int. 2006;23(6):1379-87. doi: 10.1080/07420520601067931.
Background: PubMed 4719486Hoddes E, Zarcone V, Smythe H, Phillips R, Dement WC. Quantification of sleepiness: a new approach. Psychophysiology. 1973 Jul;10(4):431-6. doi: 10.1111/j.1469-8986.1973.tb00801.x. No abstract available.
Background: PubMed 7573780Bohn MJ, Krahn DD, Staehler BA. Development and initial validation of a measure of drinking urges in abstinent alcoholics. Alcohol Clin Exp Res. 1995 Jun;19(3):600-6. doi: 10.1111/j.1530-0277.1995.tb01554.x.
Background: PubMed 9056084Hummel T, Sekinger B, Wolf SR, Pauli E, Kobal G. 'Sniffin' sticks': olfactory performance assessed by the combined testing of odor identification, odor discrimination and olfactory threshold. Chem Senses. 1997 Feb;22(1):39-52. doi: 10.1093/chemse/22.1.39.
Background: PubMed 14568478Kirsch P, Schienle A, Stark R, Sammer G, Blecker C, Walter B, Ott U, Burkart J, Vaitl D. Anticipation of reward in a nonaversive differential conditioning paradigm and the brain reward system: an event-related fMRI study. Neuroimage. 2003 Oct;20(2):1086-95. doi: 10.1016/S1053-8119(03)00381-1.
Individual participant dataSharing planned: No. Due to data protection rules, individual data cannot be shared. Cumulated data on the group level can be made available for meta-analyses on request.

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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.

Gordon B Feld, Dr principal investigator

ZI Mannheim, Department of Clinical Psychology, RG Psychology and Neurobiology of Sleep and Memory

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

Questions about this trial

What is this clinical trial studying?

A study testing Non-Alcoholic Odour, Alcoholic Odour and Non-Alcoholic Images in people with Heavy Drinking, 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 3 inclusion and 4 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 31 Jan 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.

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?

Change in Blood Oxygen Level Dependent (BOLD) signal within selected Regions of Interest (ROI) (time frame: Once during the fMRI experiment). The study lists 4 primary outcomes in all. 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 NCT05189379, which also lists 6 linked publications.

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 31 Jan 2024.