Chronic Opioid use on Brain and Behaviour

Recruiting

• Conditions: Opioid use disorderChronic (non-cancer) pain, treated with opioids; patients are not addicted to opioids.

• Registration Number: DRKS00024515
• Lead Sponsor: niversitätsklinikum Hamburg-Eppendorf

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-19
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 138

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).

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
europsychological profile and neural correlates underlying regulatory control associated with chronic opiate use.

Secondary Outcome Measures

Name	Time	Method
Identification of potential mediator and moderator variables and their neural correlates, which explain why opioid use spirals out of control. <br>