Status:
COMPLETED
How Stress Alters Opioid Drug Effects
Lead Sponsor:
University of Oslo
Collaborating Sponsors:
Oslo University Hospital
Linkoeping University
Conditions:
Motivation
Drug Effect
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The main objective of the study is to test the hypothesis that opioid drug effects vary as a function of pre-drug affective state. Specifically, it is hypothesized that social stress induction enhance...
Detailed Description
Healthy participants complete four experiment sessions in a placebo-controlled, double-blind, randomized repeated-measures psychopharmacological study. Participants completed four combinations of pre-...
Eligibility Criteria
Inclusion
- Mentally and physically healthy
- Body mass index (BMI) in the healthy range (18.5 \< BMI \< 30)
- Normal or corrected vision
- Had received an opioid drug at least once in their lifetime (to ensure no severe adverse or allergic reactions).
Exclusion
- Any significant physical health problem (e.g., heart, lung, kidney, liver, and other conditions)
- Current or past substance use problems
- Current mental health problems
- Past mental health problems beyond mild episodic anxiety or depression
- Social anxiety or fear of public speaking
- Past or current chronic pain
- Pregnancy or breastfeeding
- Recent use of any contraindicating medications
- Prior difficulty in providing blood samples.
- All exclusion criteria required a 'yes' or 'no' response from participants. Participants were also asked to report any illnesses or medical conditions that were not covered by the questions in the clinical interview. Mental health and substance use were assessed during the clinical interview using the Mini-International Neuropsychiatric Interview (MINI). The interview required binary responses to questions regarding a wide range of psychological symptoms relevant for DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) and ICD-10 (International Classification of Diseases) psychiatric disorders. Interviewers then used the pre-defined cut offs relevant to the severity of symptoms for each psychiatric disorder to assist the clinical judgement.
Key Trial Info
Start Date :
November 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 28 2022
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06485817
Start Date
November 15 2021
End Date
April 28 2022
Last Update
July 5 2024
Active Locations (1)
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1
University of Oslo
Oslo, Norway, 0317