Clinical trial NCT05189379: Targeted Extinction of Drug Cues During Sleep - Olfactory Cue Reactivity Task
Official title: Targeted Extinction of Drug Cues During Sleep - Olfactory Cue Reactivity Task
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heavy Drinking
Keywords: Cue Reactivity Task
Heavy Drinking
Olfactory Cue Reactivity Task
Lead sponsor: Central Institute of Mental Health, Mannheim
Sponsor class: OTHER
First posted: 2022-01-12
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Blood Oxygen Level Dependent (BOLD) signal within selected Regions of Interest (ROI)
timeFrame: Once during the fMRI experiment
measure: Odour based cue reactivity task
timeFrame: Once during the fMRI screening
measure: Image based cue reactivity task
timeFrame: Once during the fMRI screening
measure: Monetary incentive delay task
timeFrame: Once during the fMRI screening
Secondary outcomes:
measure: Psychomotor Vigilance Test (Roach et al. 2006)
timeFrame: Once before the fMRI screening
measure: Stanford Sleepiness Scale (Hoddes et al. 1973)
timeFrame: Once before the fMRI screening
measure: Alcohol Urge Questionnaire (Bohn et al. 1995)
timeFrame: Once before the fMRI screening
measure: Sniffin' Sticks Test (Burghardt®, Wedel, Germany)(Hummel et al., 1997)
timeFrame: Once before the fMRI screening
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Zentralinstitut für Seelische Gesundheit Mannheim
state: Baden-Württemberg
Study officials:
affiliation: ZI Mannheim, Department of Clinical Psychology, RG Psychology and Neurobiology of Sleep and Memory
name: Gordon B Feld, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.