MotivationOPIOIDREWARDNCT06485817
How Stress Alters Opioid Drug Effects
A study testing Oxycodone and Stress State Induction in people with Motivation and Drug Effect, run by University of Oslo at 1 site in Norway.
Trial 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 enhances opioid drug wanting compared a non-stress control condition. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Motivation, Drug Effect, Stress Reaction
- What is being tested?
- Oxycodone and Stress State Induction
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteNorway
- Study dates
- 15 Nov 2021to 28 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: How Distress Alters Opioid Drug Effects and Abuse Liability
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 enhances opioid drug wanting compared a non-stress control condition.
Read the 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-drug state induction (social stress or no-stress) and drug (intravenous oxycodone or saline).
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
- Motivation, Drug Effect, Stress Reaction, Misuse, Opioid
- Being tested
- Oxycodone, Placebo, Stress State Induction, Control State Induction
- Medical subject headings
- Fractures, Stress, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxycodoneDrug
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.
PlaceboDrug
Also called Saline
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 InductionBehavioural
Also called ReSST (Repeatable Social Stress Test): Stress
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 InductionBehavioural
Also called ReSST (Repeatable Social Stress Test): Control
Two different control tasks matched to the stress conditions on key parameters outlined in the protocol.
| Study group | Role | What they receive |
|---|---|---|
| Placebo_Control | Placebo comparator | 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. Receives: Drug: Placebo; Behavioral: Control State Induction |
| Oxycodone_Control | Active comparator | 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. Receives: Drug: Oxycodone; Behavioral: Control State Induction |
| Placebo_Stress | Active comparator | 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. Receives: Drug: Placebo; Behavioral: Stress State Induction |
| Oxycodone_Stress | Experimental | 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. Receives: Drug: Oxycodone; Behavioral: Stress State Induction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of oxycodone self-administered in the behavioral drug wanting task relative to the first sampling dose (0-125%).
The number corresponds to the achieved cursor placement on a vertical electronic scale indicated desired effect intensity from second dose relative to the first (sampling) dose. Cursor placement depends on the amount of effort exerted (keyboard presses) and the task difficulty adapted to performance. The task ended abruptly after 2 minutes.
Measured: Single measure: final task result ~22 minutes after sampling dose
Self-report of oxycodone wanting relative to the first sampling dose (0-125 %)
Self-reported target effect intensity was indicated on a vertical scale at the onset of the behavioral drug wanting task before the effortful part of the task.
Anchors visible to to participants were: "no effect/drug", "half the effect", "same effect", "a little stronger effect than the first drug dose". Numerically the scale anchors were 0-125 (VAS) where 100 corresponded to the "same effect".
Measured: Single measure: ~20 minutes after sampling dose
Self-reported drug wanting from "drug effects questionnaire".
Drug effects questionnaire (DEQ) take again item indicated on a 0-100 electronic Visual analogue scale (VAS) at two survey timepoints after the drug administration. Anchors were 'neutral' and 'very much'. Average rating was used.
Measured: From the drug administration until the start of the self-administration task (~15 minutes)
Secondary outcomes (6)
Stress response 1: increase in self-reported stress to the primary stress induction and subsequent stress reinstatement (as compared to control tasks).
Change in ratings on the item "feeling stressed" measured on a 0-100 Visual Analogue Scale (VAS) The following items were collected to assess stress effects: anxious, self-conscious, embarrassed, vulnerable, happy, relaxed, irritable, confident, shaky, distressed, flushed face, heart palpitations, stomach discomfort, dizzy (to stress on a 0-100 VAS) and report this in the supplementary materials.
Measured: From the measure before state induction until the end of the state induction (~20 minutes).
Stress response 2: increase in physiological stress measured by heart rate (beats per minute: BMP) induced by the primary stress induction.
Heart rate change during the state induction compared to the time period before state induction.
Measured: Data from 20 minutes before to 20 minutes after the middle of the stress induction were used to estimate the heart rate increase
Stress response 3: change in endocrine stress response measured by cortisol induced by the primary stress induction.
Estimates of plasma cortisol levels changes from the baseline (2 blood samples) to the samples after the state induction (4 blood samples).
Measured: Throughout the experiment session (~3 hours, 6 samples)
Changes in positive and negative affect after the state manipulations (induction and reinstatement) and drug administrations
Select items from the PANAS based on pilot data. Baseline measures are collected several times before the state induction. Items were rated on a 0-100 Visual Analogue Scale (VAS).
Negative affect (mood) items = "distressed", "anxious", "vulnerable", "irritable" Positive affect (mood) items = "good", "happy", "confident", "safe", "relaxed"
Composite ratings from all measures collected throughout each session (k=11 measures) will be reported as descriptive information.
Measured: From immediately before to immediately after the state induction (~20 minutes)
Drug effects questionnaire (DEQ)
Drug effect, liking and disliking was measured using items from the Drug Effects Questionnaire (DEQ; 'Feel effect', 'Like effect', 'Dislike effect') measured on an electronic 0-100 VAS, anchors 'neutral' and 'very much'.
Measured: From the drug administration until the start of the self-administration task (~15 minutes)
Side effects
To assess the overall drug- and side effects, the following items were collected on a 0-100 electronic VAS: feeling high, blunted and dizzy.
Additional items will be explored and reported where relevant and in the supplementary materials (feeling good, euphoric, indifferent, safe, dry mouth, nauseous, "not like myself").
Measured: From the drug administration until the start of the self-administration task (~15 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start15 Nov 2021
- Primary completion28 Apr 2022
- Study completion28 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MotivationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Cross-over 2\*2 design Drug (i.v. oxycodone/placebo) State induction (stress/control)
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital, Linkoeping University
- Responsible party
- Principal investigator, Marie Eikemo, University of Oslo
- Investigators
- Siri Leknes, PhD, Principal investigator, University of OsloMarie Eikemo, PhD, Principal investigator, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06485817
- Sponsor's protocol ID
- 802885
- Other IDs
- https://osf.io/bcxv8
- Acronym
- OPIOIDREWARD
- Status last verified
- Jul 2024
- First submitted
- 7 Jun 2024
- Last updated
- 5 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized information (non sensitive) will be shared on the Open Science Framework (OSF) at the time of publication.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Distress Alters Opioid Drug Effects and Abuse Liability
- ClinicalTrials.gov ID
- NCT06485817
- Acronym / sponsor ID
- OPIOIDREWARD / 802885
- Conditions
- Motivation, Drug Effect, Stress Reaction, Misuse, Opioid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Collaborators
- Oslo University Hospital, Linkoeping University
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 28 Apr 2022 (actual)
- Study completion
- 28 Apr 2022 (actual)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 enhances opioid drug wanting compared a non-stress control condition.
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-drug state induction (social stress or no-stress) and drug (intravenous oxycodone or saline).
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- Cross-over 2*2 design Drug (i.v. oxycodone/placebo) State induction (stress/control)
| Arm | Type | Receives |
|---|---|---|
| Placebo_Control | Placebo comparator | Drug: Placebo, Behavioral: Control State InductionControl 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. |
| Oxycodone_Control | Active comparator | Drug: Oxycodone, Behavioral: Control State InductionControl 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. |
| Placebo_Stress | Active comparator | Drug: Placebo, Behavioral: Stress State InductionState 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. |
| Oxycodone_Stress | Experimental | Drug: Oxycodone, Behavioral: Stress State InductionState 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxycodone3.1mg 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. | Drug | Oxycodone_Control, Oxycodone_Stress |
| PlaceboAlso: SalinePure 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. | Drug | Placebo_Control, Placebo_Stress |
| Stress State InductionAlso: ReSST (Repeatable Social Stress Test): StressReSST 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. | Behavioural | Oxycodone_Stress, Placebo_Stress |
| Control State InductionAlso: ReSST (Repeatable Social Stress Test): ControlTwo different control tasks matched to the stress conditions on key parameters outlined in the protocol. | Behavioural | Oxycodone_Control, Placebo_Control |
Primary outcome
Amount of oxycodone self-administered in the behavioral drug wanting task relative to the first sampling dose (0-125%).
Time frame: Single measure: final task result ~22 minutes after sampling dose
The number corresponds to the achieved cursor placement on a vertical electronic scale indicated desired effect intensity from second dose relative to the first (sampling) dose. Cursor placement depends on the amount of effort exerted (keyboard presses) and the task difficulty adapted to performance. The task ended abruptly after 2 minutes.
Self-report of oxycodone wanting relative to the first sampling dose (0-125 %)
Time frame: Single measure: ~20 minutes after sampling dose
Self-reported target effect intensity was indicated on a vertical scale at the onset of the behavioral drug wanting task before the effortful part of the task. Anchors visible to to participants were: "no effect/drug", "half the effect", "same effect", "a little stronger effect than the first drug dose". Numerically the scale anchors were 0-125 (VAS) where 100 corresponded to the "same effect".
Self-reported drug wanting from "drug effects questionnaire".
Time frame: From the drug administration until the start of the self-administration task (~15 minutes)
Drug effects questionnaire (DEQ) take again item indicated on a 0-100 electronic Visual analogue scale (VAS) at two survey timepoints after the drug administration. Anchors were 'neutral' and 'very much'. Average rating was used.
6 secondary outcomes
Stress response 1: increase in self-reported stress to the primary stress induction and subsequent stress reinstatement (as compared to control tasks).
Time frame: From the measure before state induction until the end of the state induction (~20 minutes).
Stress response 2: increase in physiological stress measured by heart rate (beats per minute: BMP) induced by the primary stress induction.
Time frame: Data from 20 minutes before to 20 minutes after the middle of the stress induction were used to estimate the heart rate increase
Stress response 3: change in endocrine stress response measured by cortisol induced by the primary stress induction.
Time frame: Throughout the experiment session (~3 hours, 6 samples)
Changes in positive and negative affect after the state manipulations (induction and reinstatement) and drug administrations
Time frame: From immediately before to immediately after the state induction (~20 minutes)
Drug effects questionnaire (DEQ)
Time frame: From the drug administration until the start of the self-administration task (~15 minutes)
Side effects
Time frame: From the drug administration until the start of the self-administration task (~15 minutes)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- Time locked preregistration prior to data collectionLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Anonymized information (non sensitive) will be shared on the Open Science Framework (OSF) at the time of publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Siri Leknes, PhD principal investigator
University of Oslo
Marie Eikemo, PhD principal investigator
University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxycodone and Stress State Induction in people with Motivation and Drug Effect, run by University of Oslo at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of oxycodone self-administered in the behavioral drug wanting task relative to the first sampling dose (0-125%). (time frame: Single measure: final task result ~22 minutes after sampling dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2024.