Compulsive Sexual Behavior Disorder
Conditions
Interventions
Trade Name: Naltrexon Vitaflo 50 mg, tablets for oral treatment.
Pharmaceutical Form: Tablet
INN or Proposed INN: NALTREXONE
CAS Number: 16590-41-3
Concentration unit: mg milligram(s)
Concentration ty
Sponsors
Karolinska Universitetssjukhuset
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age 18 - 65 years - Signed Informed Consent - Able to understand Swedish language, written and spoken. Be able to use internet. - Willingness to attend all visits including blood sampling and urine analysis - Fulfill the criterias of Compulsive Sexual Behaviour Disorder - Women of childbearing potential must practice a highly effective method of birth control throughout the study 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 80 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - AST and ALT greater than 3 x ULN - Ongoing treatment with opioids or benzodiazepines - Self reported use of illegal drugs during the last month, or presence of abuse in urine at inclusion - Hazardous consumption of alcohol during the last month, or alcohol abuse. AUDIT >8. - Severe psychiatric desease e.g. psychosis or major depression with immediate need of helath care - History of hepatic- or renal impairment. - Severe somatic condition including unstable heart disease or uncontrolled seizures. - Current treatment with SSRI or Naltrexone, or history of allergy to these treatments - Changes in treatment regimen or doses the last three month of following therapies: anti depressive, ADHD (minor changes weekdays but not weekends may be accepted, as judged by the investigator) antimanic agents, anti psychotic, cortisone, testosterone, L-Dopa - Current use of medications which have serious interactions with fluoxetine e.g. MAO-inhibitors, cocillana-etylmorfin and metoprolol. - Pregnancy, lactating or inadequate birth control within women of childbearing potential. - Current psychotherapy. Family counselling may be accepted, as judged by the study psychologist. - Any psychological condition that may interfere the patients health or the scientific parts of the study, e.g. intelectual disability - Already enrolled into a clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Is treatment with naltrexone more efficient than Fluoxetine in patients with Compulsive Sexual Behavior Disorder.;Secondary Objective: - If treatment with naltrexone is more efficient than fluoxetin in patients with Compulsive Sexual Behaviour Disorder, which clinical, psychosocial or biological factors can predict treatment respons? - Is there any difference in drop out and treatment compliance between the two treatment groups? - Which side effects of the study drug and the standard treatment is reported in this patient group? - Is there any connection between drop out and reports of side effects and/or effect? - Is it any difference if the patient whish to resume the treatment? - In what way does compulsive sexual behavoiur disorder correlate with impulsiveness, expeience of violence/trauma and suicidality? - Is there any biological markers associated with compulsive sexual behaviour disorder and clinical parameters in the patient group?;Primary end point(s): Questionnaire HD: CAS ;Timepoint(s) of evaluation of this end point: Measured at week 2, week 4, week 6, week 8 and at Follow Up, six weeks after end of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Sub analysis of clinical characteristics e.g. psychiatric co-morbidity, questionnaires and biological markers. Measured at baseline, week 8, week 14 and future analysis - Number of drop outs, reported compliance, pill count, verified intake (measured by urine and blood analysis at week 8 and week 14) between the two groups. - Differences in reported side effects and comparison with the above variables. Measured at week 8. - Answer in the web-platform, on the direct question of resuming the treatment. Measured at week week 14 - Analysis of screening and measurements of KIVS, CTQ and MINI at baseline. - Analysis of biological material at baseline and future analysis.;Timepoint(s) of evaluation of this end point: - Sub analysis of clinical characteristics e.g. psychiatric co-morbidity, questionnaires and biological markers. Measured at baseline, week 8, week 14 and future analysis - Number of drop outs, reported compliance, pill count, verified intake (measured by urine and blood analysis at week 8 and week 14) between the two groups. - Differences in reported side effects and comparison with the above variables. Measured at week 8. - Answer in the web-platform, on the direct question of resuming the treatment. Measured at week week 14 - Analysis of screening and measurements of KIVS, CTQ and MINI at baseline. - Analysis of biological material at baseline and future analysis. | — |
Countries
Sweden
Contacts
Public ContactCentrum för psykitariforskning
Karolinska Universitetssjukhuset
Outcome results
None listed