How Stress Alters Opioid Drug Effects
NCT Number: NCT06485817
Acronym: OPIOIDREWARD
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Motivation|Drug Effect|Stress Reaction|Misuse, Opioid
Interventions: DRUG: Oxycodone|DRUG: Placebo|BEHAVIORAL: Stress State Induction|BEHAVIORAL: Control State Induction
Sponsor: University of Oslo
Collaborators: Oslo University Hospital|Linkoeping University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2021-11-15
Completion Date: 2022-04-28
Locations: University of Oslo, Oslo, 0317, Norway

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.

Primary Outcome Measures: 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., 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"., 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., From the drug administration until the start of the self-administration task (~15 minutes)
Secondary Outcome Measures: 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., 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., 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)., 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., 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'., 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")., From the drug administration until the start of the self-administration task (~15 minutes)