Status:
RECRUITING
Cue Effects in Human Addiction: Pavlovian to Instrumental Transfer
Lead Sponsor:
Charite University, Berlin, Germany
Collaborating Sponsors:
Technische Universität Dresden
Conditions:
Alcohol Use Disorder (AUD)
Alcoholism
Eligibility:
All Genders
16-65 years
Brief Summary
Individuals with substance use disorders (SUD) have to cope with drug-related cues and contexts, which can affect instrumental drug seeking as shown with Pavlovian to instrumental transfer (PIT) parad...
Detailed Description
This project has four research aims: 1. The investigators want to assess the effects of acute as well as repeated stress exposure on PIT and its neuroimaging correlates, and the investigators will te...
Eligibility Criteria
Inclusion
- males and females between 16-65 years of age
- AUD subjects only: meet a minimum of 2 criteria for DSM-5 alcohol-related disorder (AUD) (not requiring withdrawal as assessed by an independent psychiatrist) and AUDIT \> 4
- Smokers: Daily smokers only: smoke 7 days/week during the last three months
- Non-daily smokers only: smoke at least once but less than 7 days/week during the last three months
- Ability to consent to the study and complete the questionnaires
- Sufficient language skills: German
- Availability between 3pm-6pm on 2 consecutive days (Experiment 1, acute stress question)
- Females only: luteal phase (Experiment 1, acute stress question)
Exclusion
- Lifetime diagnosis according to DMS-5 for: Bipolar disorder, schizophrenia, schizophrenia spectrum disorder, substance dependence except for alcohol, nicotine, or cannabis
- Currently meeting DSM-5 diagnostic criteria for a depressive episode, suicidal ideation
- Past traumatic brain injury or severe neurological disease (such as dementia, Parkinson's disease, multiple sclerosis)
- Pregnancy or breastfeeding
- Ingestion of medications known to interact with the CNS in the 10-day period prior to study participation or less than 4 half-lives after last ingestion (rapid urine test)
- MR contraindications (e.g., pacemakers, metallic or electronic implants, metallic splinters, surgical staples)
- Color vision deficiency
- Sensorineural hearing loss of 30 dB or greater,
- Tinnitus
- Presence of claustrophobia
- Acute alcohol intoxication at MRI appointments verified by breath alcohol testing or drug intoxication verified by rapid urine testing
- For women only: not peri- or postmenopausal, not taking contraceptives (Experiment 1, acute stress question)
Key Trial Info
Start Date :
November 24 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT05992272
Start Date
November 24 2020
End Date
December 31 2024
Last Update
August 21 2024
Active Locations (2)
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1
Charite - Universitätsmedizin Berlin
Berlin, Germany, 10117
2
Technische Universität Dresden
Dresden, Germany, 01307