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Chronic Opioid use on Brain and Behaviour

Chronic Opioid use on Brain and Behaviour - COBB

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00024515
Enrollment
138
Registered
2021-02-19
Start date
2021-05-02
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid use disorder Chronic (non-cancer) pain, treated with opioids

Interventions

Group 1: Opioid-addicted patients will undergo the following 3 stages: 1) General assessment, including diagnosis/psychopathology, personality traits
2) a neurocognitive testbattery, 3) functional MRI. Group 2: Non-addicted patients who take opioids for the treatment of chronic pain will undergo the following 3 stages: see Arm 1. Group 3: Healthy c

Sponsors

Universitätsklinikum Hamburg-Eppendorf
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 60 Years

Inclusion criteria

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: 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).

Design outcomes

Primary

MeasureTime frame
Neuropsychological profile and neural correlates underlying regulatory control associated with chronic opiate use.

Secondary

MeasureTime frame
Identification of potential mediator and moderator variables and their neural correlates, which explain why opioid use spirals out of control.

Countries

Germany

Contacts

Public ContactCaspar Geißler

Universitätsklinikum Hamburg-Eppendorf

c.geissler@uke.de+49 (0)40 7410-59899

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026