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

January 30, 2024 updated by: Central Institute of Mental Health, Mannheim
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden-Württemberg
      • Mannheim, Baden-Württemberg, Germany, 68159
        • Zentralinstitut für Seelische Gesundheit Mannheim

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Olfaction First
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
Other: Non-Alcoholic Odour
A chemical used in fragrances and flavouring with a smell close to a nutty, buttery structure. Used as a 1:100 deionised water dilution.
Other Names:
  • Coffee furanone
  • 2-Methyltetrahydrofuran-3-one
Other: Alcoholic Odour
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.
Other Names:
  • Beer
  • Wine
  • Schnapps
Other: Non-Alcoholic Images
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
Other: Alcoholic Images
Images of alcoholic items, namely, beer, wine, schnapps are presented in parallel with the alcoholic odour
Experimental: Image First
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
Other: Non-Alcoholic Odour
A chemical used in fragrances and flavouring with a smell close to a nutty, buttery structure. Used as a 1:100 deionised water dilution.
Other Names:
  • Coffee furanone
  • 2-Methyltetrahydrofuran-3-one
Other: Alcoholic Odour
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.
Other Names:
  • Beer
  • Wine
  • Schnapps
Other: Non-Alcoholic Images
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
Other: Alcoholic Images
Images of alcoholic items, namely, beer, wine, schnapps are presented in parallel with the alcoholic odour

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Once during the fMRI experiment
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".
Once during the fMRI screening
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".
Once during the fMRI screening
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.
Once during the fMRI screening

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Institute of Mental Health, Mannheim

Investigators

  • Principal Investigator: Gordon B Feld, Dr, ZI Mannheim, Department of Clinical Psychology, RG Psychology and Neurobiology of Sleep and Memory

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2022

Primary Completion (Actual)

May 25, 2023

Study Completion (Actual)

May 25, 2023

Study Registration Dates

First Submitted

December 27, 2021

First Submitted That Met QC Criteria

December 27, 2021

First Posted (Actual)

January 12, 2022

Study Record Updates

Last Update Posted (Estimated)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • tedds_ocrt_1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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