Experiencing the self through touch - self-other-distinction in an altered state of self: An exploratory randomized placebo-controlled experimental medicine study

Phase 1

• Conditions: Healthy volunteer.; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2020-004487-25-SE
• Lead Sponsor: inköpings Universitet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-29
• Study Completion: 2022-11-25
• Last Update Posted: 18 March 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1.Age 18-65 years, and willing to provide informed consent.
2.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, TSH, AST, ALT, and GGT. The final decision will be according to the judgment of the lead physician.
3.Proficiency in Swedish.
4.Fertile 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.
5.Participant must be willing to receive two i.v. lines and undergo an MRI scan.
6.Participant must be willing to perform the touch task including self-touch and receiving touch from the investigator on the arm.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Any clinically significant medical condition, including CNS, cardiovascular, respiratory, gastrointestinal, hepatic, renal, endocrine, or reproductive disorders, as assessed by the Principal Investigator (PI) or designee, after appropriate consults if needed.
2.Known hypersensitivity to ketamine, eclampsia, pre-eclampsia, increased intraocular pressure, hyperthyroidism, hydrocephalus, hypertension.
3.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 as assessed by PI or designee. 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.
4.Any medical condition that, in the judgment of the PI or designee and after appropriate consultation if needed, is likely to influence cerebral blood flow or gross-level brain activity/anatomy, such as for instance: type-1 diabetes, cardiovascular or respiratory disease, history of significant head injury, hyper-/hypothyroidism, epilepsy.
5.History of psychotic experiences and familial history (first and second degree relatives) of psychosis or alcohol use disorder.
6.Any use of CNS-active medications, use of prescription or over-the-counter drugs that could interfere with the ketamine administration. This includes Theophylline, Suxametonium, Atracurium, Diazepam, Vasopressin, barbiturates, Ergometrine, sympathomimetics, narcotics and sedatives, inhalation anesthetics, muscular relaxants, thyroid hormones, antihypertensive agents, CYP3A4 inhibitors ((e g itraconazole, fluconazole, clarithromycin, erythromycin, verapamil, diltiazem) and CYP3A4 inducers (e.g. phenytoin, carbamazepine, St John´s Wort).
7.Unable to provide a negative urine drug screen (including amphetamine, THC, opiates and benzodiazepines).
8.Pregnancy, intention to become pregnant, or breastfeeding.
9.Contraindications for magnetic resonance imaging (MRI) scanning, including ferromagnetic objects in the body that are contraindicated for MRI, and claustrophobia.
10.Any other condition due to which, in the judgment of the PI or designee, participation in the study is not in the subject’s best interest, or is unlikely to yield valid data.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified