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Morphine effects on stress response and social interaction – an exploratory randomized controlled experimental medicine study
EU CTIS ID: 2024-517855-10-00
What this study is testing
The primary objective of the study is to determine the effects of the prototypical opioid morphine on the neural, physiological, and subjective response to emotional distress of rejection in healthy controls.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age 18-65 years, and willing to provide informed consent.
- Good health as determined by medical history, ECG, and clinical assessment of lab tests. Lab tests will include potassium, creatinine, hemoglobin, glucose, calcium, BUN, complete blood count, total bilirubin, AST, ALT, and GGT. The final decision will be according to the judgment of the lead physician.
- Proficiency in Swedish
- Females must have a negative urine pregnancy test (hCG) at inclusion and at the start of each study session. Females of childbearing potential who are sexually active and have not been surgically sterilized must agree to use an adequate method of birth control during the study.
- Participant must be willing to receive two IV lines and undergo an MR scan
- Right-handedness assessed by the Edinburgh Handedness Inventory (EHI)
You likely can't join if
- Any clinically significant medical condition, including CNS, cardiovascular, respiratory, gastrointestinal, hepatic, renal, endocrine, or reproductive disorders.
- Any current clinically significant psychiatric problems including a diagnosis of substance dependence other than nicotine (defined in DSM-5 terms as Substance Use Disorder, Moderate or Severe). Patients will be screened using the Modified Mini Screen (MMS), the Drug Use Disorder Identification Test (DUDIT), a urine drug screening, and the Alcohol Use Disorder Identification Test (AUDIT). The results and their clinical significance will ultimately be evaluated by a trained healthcare professional (psychiatrically trained nurse or physician). If indication is obtained that a clinically significant psychiatric disorder may be present, a full MINI interview will be carried out by appropriately trained staff.
- Significant adverse reaction to prior opioid exposure.
- Any current use of CNS-active medications.
- Current use of opioid analgesics, opioid use for > 6 weeks (lifetime), or within the 3 months prior to study enrollment.
- Unable to provide a negative urine drug screen (THC, amphetamine, methamphetamine, opioids, benzodiazepines, cocaine, buprenorphine, methadone, tramadol, oxycontin, fentanyl and clonazepam).
See the full eligibility criteria
Who can join
- Age 18-65 years, and willing to provide informed consent.
- Good health as determined by medical history, ECG, and clinical assessment of lab tests. Lab tests will include potassium, creatinine, hemoglobin, glucose, calcium, BUN, complete blood count, total bilirubin, AST, ALT, and GGT. The final decision will be according to the judgment of the lead physician.
- Proficiency in Swedish
- Females must have a negative urine pregnancy test (hCG) at inclusion and at the start of each study session. Females of childbearing potential who are sexually active and have not been surgically sterilized must agree to use an adequate method of birth control during the study.
- Participant must be willing to receive two IV lines and undergo an MR scan
- Right-handedness assessed by the Edinburgh Handedness Inventory (EHI)
- Prior experience with medical opioids (at least one experience with opiates such as oxycodone, morphine, hydrocodone, codeine, or dihydrocodeine).
What rules you out
- Any clinically significant medical condition, including CNS, cardiovascular, respiratory, gastrointestinal, hepatic, renal, endocrine, or reproductive disorders.
- Any current clinically significant psychiatric problems including a diagnosis of substance dependence other than nicotine (defined in DSM-5 terms as Substance Use Disorder, Moderate or Severe). Patients will be screened using the Modified Mini Screen (MMS), the Drug Use Disorder Identification Test (DUDIT), a urine drug screening, and the Alcohol Use Disorder Identification Test (AUDIT). The results and their clinical significance will ultimately be evaluated by a trained healthcare professional (psychiatrically trained nurse or physician). If indication is obtained that a clinically significant psychiatric disorder may be present, a full MINI interview will be carried out by appropriately trained staff.
- Significant adverse reaction to prior opioid exposure.
- Any current use of CNS-active medications.
- Current use of opioid analgesics, opioid use for > 6 weeks (lifetime), or within the 3 months prior to study enrollment.
- Unable to provide a negative urine drug screen (THC, amphetamine, methamphetamine, opioids, benzodiazepines, cocaine, buprenorphine, methadone, tramadol, oxycontin, fentanyl and clonazepam).
- Moderate to strong nicotine use (>14 cigarettes/week, or corresponding level of other nicotine delivering vehicles) assessed by the Fagerström Test for Nicotine Dependence (FTND).
- Pregnancy, intention to become pregnant, or breastfeeding a child.
- Contraindications for MRI scanning, including ferromagnetic objects in the body that are contraindicated for MRI, and claustrophobia.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.