Study Results
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Basic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2021-11-15
2022-04-28
Brief Summary
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Detailed Description
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Temporary and reversible social stress is induced using the Repeatable Social Stress Test (ReSST) which enables repeated administrations of stress-inductions. Across four sessions participants experience two carefully tailored tasks to provoke the experience of social evaluative threat and two non-stressful control tasks.
After each state inductions, participants receive an injection of opioid drug or saline. After a drug absorption phase and viewing of a state reinstatement video designed to evoke a mild form of social evaluative threat participants perform a drug-self-administration test to determine the potency of a second dose.
Self-reported affect, mental and physiological state and drug effects are assessed throughout the session.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
BASIC_SCIENCE
TRIPLE
Study Groups
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Placebo_Control
Control state induction:
Participants answer simple questions about their color or music preferences in a hybrid (zoom-lab) session with a friendly experimenter (The Repeatable Social Stress Test (ReSST) control conditions).
Drug administration:
A sampling dose of intravenous (i.v.) saline administered over 15 seconds through a venous catheter after the state induction. 45 minutes later participants receive the second dose of saline (0-100% of the initial sampling dose) determined by a behavioral self-administration task.
Placebo
Pure saline was administered as the placebo condition.
Based on body weight, the study nurse/anesthetist adjusted the (unknown) content in two syringes by removing enough fluid to reach a volume that would result in a dose equivalent of 3.1mg/70kg (0,043 mg/ml pr kg) should the syringes contain oxycodone.
The first dose was administered 5 minutes after the state induction task. The second dose was adjusted according to the performance on the self-administration task (but maximum 100% of the first dose) and administered 45 later.
Control State Induction
Two different control tasks matched to the stress conditions on key parameters outlined in the protocol.
Oxycodone_Control
Control state induction:
Participants answer simple questions about their color or music preferences in a hybrid (zoom-lab) session with a friendly experimenter. (The Repeatable Social Stress Test (ReSST) control conditions).
Drug administration:
A sampling dose of i.v. oxycodone administered over 15 seconds through a venous catheter after the state induction. 45 minutes later participants receive the second dose of oxycodone (0-100% of the initial sampling dose) determined by a behavioral self-administration task.
Oxycodone
3.1mg oxycodone/70 kg body weight was administered as the main drug intervention.
Based on body weight, the study nurse/anesthetist adjusted the (unknown) content in two syringes by removing enough fluid to reach a volume that would result in a dose equivalent of 3.1mg/70kg (0,043 mg/ml pr kg) should the syringes contain oxycodone.
The first dose was administered 5 minutes after the state induction task. The second dose was adjusted according to the performance on the self-administration task (but maximum 100% of the first dose) and administered 45 later.
Control State Induction
Two different control tasks matched to the stress conditions on key parameters outlined in the protocol.
Placebo_Stress
State induction: Stress The Repeatable Social Stress Test (ReSST) was used to induce psychosocial stress (mock job talk in stress session 1 and singing task in stress session 2).
Drug administration:
A sampling dose of i.v. saline administered over 15 seconds through a venous catheter after the state induction. 45 minutes later participants receive the second dose of saline (0-100% of the initial sampling dose) determined by a behavioral self-administration task.
Placebo
Pure saline was administered as the placebo condition.
Based on body weight, the study nurse/anesthetist adjusted the (unknown) content in two syringes by removing enough fluid to reach a volume that would result in a dose equivalent of 3.1mg/70kg (0,043 mg/ml pr kg) should the syringes contain oxycodone.
The first dose was administered 5 minutes after the state induction task. The second dose was adjusted according to the performance on the self-administration task (but maximum 100% of the first dose) and administered 45 later.
Stress State Induction
ReSST is an in-house hybrid online-lab implementation of two stress induction paradigms based on the Trier Social stress test (TSST) and Iowa Social Singing Stress Test (I-SSST).
The set-up was tailored to allow repeated stress induction without diminishing effects that allowed for an online experiment panel. Stress and control state inductions were administered every-other session. The singing version of the stress test was always administered last as it was deemed more stressful during piloting.
Oxycodone_Stress
State induction: Stress ReSST was used to induce psychosocial stress (mock job talk in stress session 1 and singing task in stress session 2).
Drug administration:
A sampling dose of i.v. oxycodone administered over 15 seconds through a venous catheter after the state induction. 45 minutes later participants receive the second dose of oxycodone (0-100% of the initial sampling dose) determined by a behavioral self-administration task.
Oxycodone
3.1mg oxycodone/70 kg body weight was administered as the main drug intervention.
Based on body weight, the study nurse/anesthetist adjusted the (unknown) content in two syringes by removing enough fluid to reach a volume that would result in a dose equivalent of 3.1mg/70kg (0,043 mg/ml pr kg) should the syringes contain oxycodone.
The first dose was administered 5 minutes after the state induction task. The second dose was adjusted according to the performance on the self-administration task (but maximum 100% of the first dose) and administered 45 later.
Stress State Induction
ReSST is an in-house hybrid online-lab implementation of two stress induction paradigms based on the Trier Social stress test (TSST) and Iowa Social Singing Stress Test (I-SSST).
The set-up was tailored to allow repeated stress induction without diminishing effects that allowed for an online experiment panel. Stress and control state inductions were administered every-other session. The singing version of the stress test was always administered last as it was deemed more stressful during piloting.
Interventions
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Oxycodone
3.1mg oxycodone/70 kg body weight was administered as the main drug intervention.
Based on body weight, the study nurse/anesthetist adjusted the (unknown) content in two syringes by removing enough fluid to reach a volume that would result in a dose equivalent of 3.1mg/70kg (0,043 mg/ml pr kg) should the syringes contain oxycodone.
The first dose was administered 5 minutes after the state induction task. The second dose was adjusted according to the performance on the self-administration task (but maximum 100% of the first dose) and administered 45 later.
Placebo
Pure saline was administered as the placebo condition.
Based on body weight, the study nurse/anesthetist adjusted the (unknown) content in two syringes by removing enough fluid to reach a volume that would result in a dose equivalent of 3.1mg/70kg (0,043 mg/ml pr kg) should the syringes contain oxycodone.
The first dose was administered 5 minutes after the state induction task. The second dose was adjusted according to the performance on the self-administration task (but maximum 100% of the first dose) and administered 45 later.
Stress State Induction
ReSST is an in-house hybrid online-lab implementation of two stress induction paradigms based on the Trier Social stress test (TSST) and Iowa Social Singing Stress Test (I-SSST).
The set-up was tailored to allow repeated stress induction without diminishing effects that allowed for an online experiment panel. Stress and control state inductions were administered every-other session. The singing version of the stress test was always administered last as it was deemed more stressful during piloting.
Control State Induction
Two different control tasks matched to the stress conditions on key parameters outlined in the protocol.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
65 Years
ALL
Yes
Sponsors
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Oslo University Hospital
OTHER
Linkoeping University
OTHER_GOV
University of Oslo
OTHER
Responsible Party
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Marie Eikemo
Co-Principal Investigator
Principal Investigators
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Siri Leknes, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Oslo
Marie Eikemo, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Oslo
Locations
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University of Oslo
Oslo, , Norway
Countries
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Study Documents
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Document Type: Analytic Code
Project directory where study relevant documentation can be found and data will be uploaded.
View DocumentRelated Links
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Time locked preregistration prior to data collection
Other Identifiers
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https://osf.io/bcxv8
Identifier Type: OTHER
Identifier Source: secondary_id
802885
Identifier Type: -
Identifier Source: org_study_id
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