Investigating how stress affects addiction cues and control in substance use disorders
Cue Effects in Human Addiction: Pavlovian to Instrumental Transfer
This study is testing how stress affects cravings and control over substance use in people with alcohol and smoking addictions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 16 Years to 65 Years |
| Sex | All |
| Sponsor | Charite University, Berlin, Germany Academic / other |
| Locations | 2 sites (Berlin and 1 other locations) |
| Trial ID | NCT05992272 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the effects of acute and chronic stress on Pavlovian-to-instrumental transfer (PIT) in individuals with substance use disorders, particularly focusing on alcohol use disorder (AUD) and smoking. The researchers will assess cognitive control abilities and their relationship with drug-seeking behavior, using neuroimaging techniques to identify underlying neural mechanisms. The study involves multiple experiments to compare general and outcome-specific PIT between AUD subjects and healthy controls, aiming to understand how stress influences addiction behaviors. Participants will engage in various tasks, including fMRI imaging and behavioral assessments, to gather comprehensive data on these interactions.
Who should consider this trial
Good fit: Ideal candidates include males and females aged 16-65 with a diagnosis of alcohol use disorder or daily smokers.
Not a fit: Patients with severe mental health disorders such as bipolar disorder or schizophrenia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into how stress management might improve control over substance use in patients with addiction.
How similar studies have performed: Other studies have shown promising results in understanding the relationship between stress and addiction cues, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Berlin and 1 other locations
- Charite - Universitätsmedizin Berlin — Berlin, Germany (Recruiting)
- Technische Universität Dresden — Dresden, Germany (Recruiting)
Study contacts
- Study coordinator: Andreas Heinz, Prof., MD, PhD
- Email: andreas.heinz@charite.de
- Phone: 0049 30 450 517 001
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.