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

NCT ID: NCT05189379

Last Updated: 2024-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-10

Study Completion Date

2023-05-25

Brief Summary

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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.

Detailed Description

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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

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Heavy Drinking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Non-Alcoholic Odour

Intervention Type 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.

Alcoholic Odour

Intervention Type 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.

Non-Alcoholic Images

Intervention Type 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

Alcoholic Images

Intervention Type OTHER

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

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

Group Type EXPERIMENTAL

Non-Alcoholic Odour

Intervention Type 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.

Alcoholic Odour

Intervention Type 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.

Non-Alcoholic Images

Intervention Type 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

Alcoholic Images

Intervention Type OTHER

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

Interventions

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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.

Intervention Type 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.

Intervention Type 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

Intervention Type OTHER

Alcoholic Images

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

Intervention Type OTHER

Other Intervention Names

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Coffee furanone 2-Methyltetrahydrofuran-3-one Beer Wine Schnapps

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Institute of Mental Health, Mannheim

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gordon B Feld, Dr

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Zentralinstitut für Seelische Gesundheit Mannheim

Mannheim, Baden-Wurttemberg, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 21292243 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17190720 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 4719486 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7573780 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9056084 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14568478 (View on PubMed)

Other Identifiers

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tedds_ocrt_1

Identifier Type: -

Identifier Source: org_study_id

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