DRKS00024515RecruitingNot Applicable
Chronic Opioid use on Brain and Behaviour - COBB
niversitätsklinikum Hamburg-Eppendorf0 sites138 target enrollmentStarted: February 19, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 138
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 20 Years to 60 Years (—)
- Sex
- All
Inclusion Criteria
- •1) Diagnosis of opioid use disorder (moderate-severe), or 2) Diagnosis of noncancer pain syndrome treated with opioids, or 3) Good mental and physical health, no prior experience with opioids.
Exclusion Criteria
- •Exclusion criteria FOR ALL PARTICIPANTS:
- •1) A personal history of a sever psychiatric, neurological or neurodevelopmental disorder,
- •2) A history of a head or brain trauma,
- •3) Personal history of regular stimulant drug use (for medical or non-medical purposes)
- •4) Contraindication to MRI scanning (e.g. stents, pace-maker, dental braces, claustrophobia),
- •5) Severe physical impairments affecting eyesight or motor performance,
- •6) Any serious medical disorder or condition that would in the investigator’s opinion preclude participation in the study,
- •7) Acute alcohol intoxication (verified by alcohol breath test),
- •8) Current pregnancy,
- •9) Insufficient proficiency of German to provide informed consent and to understand task instructions.
- •Additional exclusion criteria FOR CONTROL PARTICIPANTS:
- •1) Personal or family history of substance use disorder
- •2) Personal history of chronic pain
- •3) Drug-positive urine screen on the day of testing/scanning
- •4) Harmful alcohol use (AUDIT > 8)
- •5) Harmful cannabis use (CUDIT-R > 13)
- •6) Subclinical levels of depression (DASS-21 > 13)
- •7) Subclinical levels of anxiety (DASS-21 > 9)
- •8) Involvement in a Clinical Trial of an investigational drug within the last 3 months.
- •9) Current psychoactive medication
- •Additional exclusion criteria FOR PATIENTS WITH CHRONIC PAIN:
- •1) Signs of opioid misuse
- •2) Personal or family history of substance use disorder
- •3) Harmful alcohol use (AUDIT > 8)
- •4) A drug-positive urine screen (except morphine or cannabis) on the day of testing/scanning.
- •Additional exclusion criteria FOR PATIENTS WITH OPIATE USE DISORDER:
- •1) A history of addiction to stimulant drugs or regular stimulant drug use (e.g. amphetamines, methamphetamine, cocaine, crack-cocaine, synthetic stimulants).
Investigators
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