Morphine hydrochloride for Healthy volunteers

Inclusion criteria

• {"criterion_text":"- Age 18-65 years, and willing to provide informed consent."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Proficiency in Swedish"}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Participant must be willing to receive two IV lines and undergo an MR scan"}
• {"criterion_text":"- Right-handedness assessed by the Edinburgh Handedness Inventory (EHI)"}
• {"criterion_text":"- Prior experience with medical opioids (at least one experience with opiates such as oxycodone, morphine, hydrocodone, codeine, or dihydrocodeine)."}

Exclusion criteria

• {"criterion_text":"- Any clinically significant medical condition, including CNS, cardiovascular, respiratory, gastrointestinal, hepatic, renal, endocrine, or reproductive disorders."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Significant adverse reaction to prior opioid exposure."}
• {"criterion_text":"- Any current use of CNS-active medications."}
• {"criterion_text":"- Current use of opioid analgesics, opioid use for > 6 weeks (lifetime), or within the 3 months prior to study enrollment."}
• {"criterion_text":"- Unable to provide a negative urine drug screen (THC, amphetamine, methamphetamine, opioids, benzodiazepines, cocaine, buprenorphine, methadone, tramadol, oxycontin, fentanyl and clonazepam)."}
• {"criterion_text":"- 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)."}
• {"criterion_text":"- Pregnancy, intention to become pregnant, or breastfeeding a child."}
• {"criterion_text":"- Contraindications for MRI scanning, including ferromagnetic objects in the body that are contraindicated for MRI, and claustrophobia."}

Primary endpoints

• {"endpoint_text":"- Subjective distress to exclusion (Visual analog scale).","definition_or_measurement_approach":"Measured as subjective distress using a Visual Analog Scale (VAS)."}
• {"endpoint_text":"- Neural response to social exclusion (fMRI BOLD-signal).","definition_or_measurement_approach":"Measured as neural response via fMRI BOLD-signal."}

Secondary endpoints

• {"endpoint_text":"- Morphine effects on behavioral, psychophysiological, and neural responses to personal distance and social approach and avoidance within group.","definition_or_measurement_approach":"Assessment of behavioral, psychophysiological, and neural responses (methods not further specified in the record)."}
• {"endpoint_text":"- Rejection-induced distress effects on stress-related biomarkers (e.g., cortisol and endocannabinoid levels) and its interaction with morphine.","definition_or_measurement_approach":"Measurement of stress-related biomarkers such as cortisol and endocannabinoid levels and their interaction with morphine."}

Sweden

Earliest CTIS Part Ii Submission Date

05-09-2024

Latest Decision Or Authorization Date

25-10-2024

Processing Time Days

50

Number Of Sites

1

Number Of Participants

36

Primary sponsor

Full Name

Linkopings Universitet

Organisation Type

Educational Institution

Country Of Registered Address

Sweden