NCT06701487 Role of Pavlovian Mechanisms for Control Over Substance Use
| NCT ID | NCT06701487 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Technische Universität Dresden |
| Condition | Alcohol Use Disorder (AUD) |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-08-05 |
| Primary Completion | 2027-06-30 |
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 200 participants in total. It began in 2024-08-05 with a primary completion date of 2027-06-30.
⚠ 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
During the first funding period (1st FP), the investigators developed a novel full Pavlovian-to-instrumental transfer (PIT) task that allows assessing both, general and specific PIT to investigate whether specific PIT differs between alcohol use disorder (AUD) and control subjects. Preliminary analyses of the full transfer task indicate that AUD participants exhibit a stronger specific PIT effect compared to controls. Based on these findings, the investigators want to compare specific and general PIT effects in patients with moderate to severe substance use disorders (alcohol, cannabis, methamphetamine, amphetamine and cocaine) to healthy controls on the behavioral and neural level (fMRI).
Eligibility Criteria
Inclusion Criteria: * Men and women between 18-65 years of age, * AUD, and/or SUD subjects only: meet 4 or more criteria for DSM-5 alcohol-related and/or substance-related (cannabis, amphetamine, methamphetamine or cocaine disorder (not requiring withdrawal as assessed by an independent psychiatrist), * Currently using alcohol without a desire for abstinence * Ability to consent to the study and complete the questionnaires. * Sufficient language(German) and motor skills for using PC * existing health insurance Exclusion Criteria: * Lifetime diagnosis of DSM-5 bipolar disorder or schizophrenia or schizophrenia spectrum disorder (if induced by drugs, it should happen more than a month ago) * Current threshold DSM-5 diagnosis of major depressive disorder, or presence of suicidal intention * High risk (≤ 26) ASSIST scores in other substances other than alcohol, amphetamine, methamphetamine, cannabis, cocaine, tobacco * History of traumatic brain injury or severe neurological disease (such as Dementia, Parkinson's disease, multiple sclerosis, Epilepsy, Meningitis, Stroke) * Pregnancy or breastfeeding, * Ingestion of medications known to interact with the dopamine system in the 10-day period prior to study participation or less than 4 half-lives after last ingestion (rapid urine test); A detailed list of permitted medication can be added upon request * 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 and * Acute alcohol, substance (cannabis, or methamphetamine, amphetamine, cocaine) intoxication at assessement day verified by breath alcohol tests and drug intoxication verified by rapid urine test.
Frequently Asked Questions
Who can join the NCT06701487 clinical trial?
This trial is open to participants of all sexes, aged 18 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 NCT06701487 currently recruiting?
Yes, NCT06701487 is actively recruiting participants. Visit ClinicalTrials.gov or contact Technische Universität Dresden to inquire about joining.
Where is the NCT06701487 trial being conducted?
This trial is being conducted at Dresden, Germany.
Who is sponsoring the NCT06701487 clinical trial?
NCT06701487 is sponsored by Technische Universität Dresden. The trial plans to enroll 200 participants.