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

NCT05189379 | Completed

• 1 other identifier: tedds_ocrt_1
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heavy Drinking

Keywords

Cue Reactivity Task; Heavy Drinking; Olfactory Cue Reactivity Task

Outcome Measures

Primary Outcomes (4)

• 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

  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".

  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".

  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.

  Once during the fMRI screening

Secondary Outcomes (4)

• Psychomotor Vigilance Test (Roach et al. 2006)

  Once before the fMRI screening

• Stanford Sleepiness Scale (Hoddes et al. 1973)

  Once before the fMRI screening

• Alcohol Urge Questionnaire (Bohn et al. 1995)

  Once before the fMRI screening

• Sniffin' Sticks Test (Burghardt®, Wedel, Germany)(Hummel et al., 1997)

  Once before the fMRI screening

Study Arms (2)

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

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

Other: Non-Alcoholic Odour; Other: Alcoholic Odour; Other: Non-Alcoholic Images; Other: Alcoholic Images

Interventions

Non-Alcoholic Odour OTHER

A chemical used in fragrances and flavouring with a smell close to a nutty, buttery structure. Used as a 1:100 deionised water dilution.

Also known as: Coffee furanone, 2-Methyltetrahydrofuran-3-one

Image First; Olfaction First

Alcoholic Odour OTHER

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.

Also known as: Beer, Wine, Schnapps

Image First; Olfaction First

Non-Alcoholic Images OTHER

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

Image First; Olfaction First

Alcoholic Images OTHER

Images of alcoholic items, namely, beer, wine, schnapps are presented in parallel with the alcoholic odour

Image First; Olfaction First

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Central Institute of Mental Health, Mannheim: lead

Study Sites (1)

Zentralinstitut für Seelische Gesundheit Mannheim

Mannheim, Baden-Wurttemberg, 68159, Germany

Location

Related Publications (6)

• 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.

  PMID: 21292243 BACKGROUND

• 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.

  PMID: 17190720 BACKGROUND

• 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.

  PMID: 4719486 BACKGROUND

• 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.

  PMID: 7573780 BACKGROUND

• 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.

  PMID: 9056084 BACKGROUND

• 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.

  PMID: 14568478 BACKGROUND

MeSH Terms

Interventions

2-methyltetrahydrofuran-3-one; Beer; Wine

Intervention Hierarchy (Ancestors)

Alcoholic Beverages; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Fermented Beverages; Fermented Foods; Food and Beverages

Study Officials

• Gordon B Feld, Dr

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 27, 2021
• First Posted: January 12, 2022
• Study Start: March 10, 2022
• Primary Completion: May 25, 2023
• Study Completion: May 25, 2023
• Last Updated: January 31, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)