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

Central Institute of Mental Health, Mannheim

Status: Completed

Conditions: Heavy Drinking

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05189379

tedds_ocrt_1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

Olfaction First

Experimental group

Description:

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

Treatment:

Other: Non-Alcoholic Images

Other: Alcoholic Images

Other: Non-Alcoholic Odour

Other: Alcoholic Odour

Image First

Experimental group

Description:

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

Treatment:

Other: Non-Alcoholic Images

Other: Alcoholic Images

Other: Non-Alcoholic Odour

Other: Alcoholic Odour