A pilot study to evaluate the possible use and effectiveness of an opiate antagonist for treatment of hypersexual disorder (sex abuse)

Phase 1

• Conditions: Hypersexual disorder; MedDRA version: 20.0Level: PTClassification code 10066364Term: HypersexualitySystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Behaviours [F01]

• Registration Number: EUCTR2018-001049-15-SE
• Lead Sponsor: ANOVA (Andrologi, Sexualmedicin, Transmedicin) Karolinska Universitetssjukhuset och Umeå Universitet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-20
• Last Update Posted: 18 August 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• A diagnosis of hypersexual disorder (as described in the protocol).
• 18- 65 years old
• Signed informed consent
• Able to understand the Swedish language orally and in written, write in Swedish and able to use the internet including having succeeded in filling out online questionnaires.
• Willing to participate to all study visits including giving blood and urine samples.

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 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Elevated liver enzymes (greater than three times the upper limit of normal for ALAT and/or ASAT).
• Ongoing opioid or benzodiazepine medication.
• Illicit self-reported use of drugs in the past month or positive drug verification analysis.
• Risk consumption of alcohol in the past month or alcohol dependence (14 units of alcohol per week for men and 9 units per week for women will be considered risk consumption).
• Severe psychiatric disorder such as current psychotic illness or severe depression requiring immediate treatment.
• History of liver or kidney failure.
• Serious physical illness.
• Change of medication or dosage in the last 3 months regarding antidepressants, ADHD-medication, mood stabilizers, anti-psychotics, cortisone, testosterone or precursor of Dopamine such as L-Dopa.
• Pregnancy and/or breast-feeding.
• Ongoing psycho-therapeutic treatment.
• History of allergic reaction to Naltrexone or its metabolites.
• Other factors that are clinical significant and could jeopardize study results or its intention, as judged by study psychiatrist or psychologist.

Study & Design

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