Actively Recruiting

Age: 18Years - 65Years
All Genders
ID06701487

Losing and Regaining Control Over Drug Intake: General and Specific Pavlovian-to-Instrumental Transfer Effects in Substance Use Disorders

Led by Technische Universität Dresden · Updated on 2024-11-22

200

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

T

Technische Universität Dresden

Lead Sponsor

C

Charite University, Berlin, Germany

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating how Pavlovian-to-instrumental transfer (PIT) effects differ in people with moderate to severe substance use disorders (SUD), including alcohol, cannabis, methamphetamine, amphetamine, and cocaine use disorders, compared to healthy individuals. This study aims to understand behavioral and brain activity differences related to control over substance use, focusing on both general and specific PIT effects. The research builds on earlier findings suggesting that alcohol use disorder (AUD) patients show stronger specific PIT effects than healthy controls. Participants are divided into four groups: those with AUD alone, those with AUD plus comorbid SUD, those with SUD without AUD, and healthy controls. They will complete a full PIT task consisting of instrumental training, Pavlovian conditioning, a transfer phase, and query trials to assess explicit knowledge. Functional MRI (fMRI) and structural MRI scans will be used to examine brain activity and structure related to PIT. Psychological assessments and neuropsychological tests will also be conducted. A follow-up will occur three months later using online questionnaires to track substance use behavior. During the study, participants will undergo behavioral tasks and brain imaging to measure neural and behavioral PIT effects. They will complete interviews and questionnaires assessing substance use, mental health, and cognitive functions. The primary outcomes include neural PIT effects measured by fMRI and behavioral PIT effects from the task. The follow-up assesses alcohol and substance consumption three months after testing. Safety screenings, including breath alcohol tests and urine drug tests, will be performed at assessment. Participants will be involved for a single testing day plus the follow-up period.

CONDITIONS

Brief Title

Role of Pavlovian Mechanisms for Control Over Substance Use

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Men and women between 18 and 65 years of age
  • Meet 4 or more DSM-5 criteria for alcohol-related and/or substance-related disorder (cannabis, amphetamine, methamphetamine, or cocaine) without withdrawal symptoms
  • Currently using alcohol without a desire for abstinence
  • Ability to consent to the study and complete questionnaires
  • Sufficient German language and motor skills for using a computer
  • Existing health insurance
Not Eligible

You will not qualify if you...

  • Lifetime diagnosis of bipolar disorder, schizophrenia, or schizophrenia spectrum disorder (drug-induced cases must be more than one month ago)
  • Current diagnosis of major depressive disorder or suicidal intention
  • High risk ASSIST scores for substances other than alcohol, amphetamine, methamphetamine, cannabis, cocaine, or tobacco
  • History of traumatic brain injury or severe neurological diseases such as dementia, Parkinson's disease, multiple sclerosis, epilepsy, meningitis, or stroke
  • Pregnancy or breastfeeding
  • Use of medications interacting with the dopamine system within 10 days before participation or less than four half-lives before the study
  • MRI contraindications such as pacemakers, metallic implants, splinters, or surgical staples
  • Color vision deficiency
  • Sensorineural hearing loss of 30 dB or greater
  • Tinnitus
  • Acute intoxication with alcohol or substances on assessment day verified by tests

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 day

Participants undergo comprehensive psychological assessments and neuropsychological tests to evaluate substance use disorder and related behavioral characteristics.

1 visit (in-person)

Imaging and Behavioral Assessment

Duration - 1 day

Participants complete the Pavlovian-to-instrumental transfer (PIT) paradigm while undergoing fMRI and sMRI scans to assess neural and behavioral correlates of substance use.

1 visit (in-person)

Long-term Monitoring

Duration - 3 months after testing

Participants complete online follow-up questionnaires 3 months after initial testing to assess clinical course and substance use.

1 follow-up online visit

Trial Site Locations

Total: 1 location

1

Department of Psychiatry and Psychotherapy, Technische Universität Dresden

Dresden, Germany

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

4

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Published Research Related To This Trial

Development of Novel Tasks to Assess Outcome-Specific and General Pavlovian-to-Instrumental Transfer in Humans.

Matthew J Belanger, Hao Chen, Angela Hentschel...

https://pubmed.ncbi.nlm.nih.gov/36380640