NCT05992272 Cue Effects in Human Addiction: Pavlovian to Instrumental Transfer
| NCT ID | NCT05992272 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Charite University, Berlin, Germany |
| Condition | Alcohol Use Disorder (AUD) |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2020-11-24 |
| Primary Completion | 2024-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2020-11-24 with a primary completion date of 2024-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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) paradigms in animals and humans. The investigators aimed to investigate the impact of acute and chronic stress on Pavlovian-to-instrumental transfer (PIT), how PIT it is associated with cognitive control abilities and whether such effects predict losing vs. regaining control in subjects with AUD. Moreover, the investigators aimed to develop a novel full transfer task that assesses both, general and specific PIT to investigate whether specific PIT differs between alcohol use disorder (AUD) and control subjects.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05992272 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, up to 65 Years, studying Alcohol Use Disorder (AUD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05992272 currently recruiting?
Yes, NCT05992272 is actively recruiting participants. Contact the research team at andreas.heinz@charite.de for enrollment information.
Where is the NCT05992272 trial being conducted?
This trial is being conducted at Berlin, Germany, Dresden, Germany.
Who is sponsoring the NCT05992272 clinical trial?
NCT05992272 is sponsored by Charite University, Berlin, Germany. The trial plans to enroll 300 participants.