Potentiation of endogenous cannabinoid signaling and unlearning of fear

Phase 1

• Conditions: Healthy volunteers (extinction of fear); MedDRA version: 19.0Level: PTClassification code 10016275Term: FearSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Behaviours [F01]

• Registration Number: EUCTR2016-005013-47-SE
• Lead Sponsor: inköping University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-03
• Last Update Posted: 22 May 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Age >18 years, and willing to provide informed consent.
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 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Lifetime diagnosis of psychosis or bipolar disease, current axis 1 diagnosis; as determined by a history, clinical examination and MINI interview carried out by appropriately trained staff

Ongoing (within the last month) psychiatric medication

Current (within the last month) use of illicit drugs, as identified using the Drug Use Disorder Identification Test (DUDIT).

Co-medication with CYP3A inhibitors, CYP3A inducers or P-glycoprotein substrates.

Any other current medication or medical condition that in the judgment of the investigator could interfere with treatment.

Pregnancy or nursing. To be eligible, women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test prior to the start of study drug. WOCBP and males with WOCBP partners must agree to use a method of contraception that is highly effective for the duration of the study and for at least 28 days after the intake of the study drug. A highly effective method of birth control is defined as one which results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner.

Clinically significant deviations from normal range of physiological functions as determined by a specialist consult when needed (blood pressure, heart rate, AST, ALT, GGT, WBC with differential, Hb, MCV, TPK, LPK and CRP).

Due to the nature of the tasks, we will also exclude anyone with hearing impairments.

Study & Design

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