tDCS in Treatment of Craving in Sexual Addiction

Sexual Addiction Clinical Trial

— CAS  

Official title:

Transcranial Electrical Stimulation in Sexual Addiction: an Innovative Treatment for a Better Understanding of the Physiopathology of Craving

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04923451
• Other study ID #: D20-P039
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: October 1, 2024

Study information

• Verified date: November 2020
• Source: Centre Hospitalier St Anne
• Contact: Leo Malandain, MD
• Phone: 0033158411678
• Email: leo.malandain[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In patients with addiction to a substance, an increase in activity in the prefrontal cortex induced by transcranial Direct Current Stimulation -tDCS (non-invasive technique, modulating cortical activity by applying low-intensity electrical currents between two electrodes),may help reduce craving in people addicted to alcohol and tobacco. By analogy with addictive behavior with a substance, the craving observed in certain behavioral addictions would involve the same neural circuits. The main hypothesis is to reduce the sexual craving associated with the viewing of erotic images during active brain stimulation compared to placebo stimulation. Functional MRI will allow to better understand the neural circuits involved in sexual addiction and in the expected inhibition of sexual arousal by tDCS in sexual addictions during visualization erotic images.

Description:

The concept of sexual addiction appeared in American literature about 20 years ago. The term sexual addiction describes an excessive, increasing, and especially uncontrolled frequency of sexual behavior, as a conventional rule, associated with a compelling and irrepressible sexual desire (craving), which persists in spite of the possible negative consequences and personal suffering of the subject. The prevalence of this condition is estimated to be approximately 3-6% in the general population in the United States, it is independent of the socio-cultural environment. The pathophysiology of sexual addictions remains very poorly understood. Numerous studies have focused on substance addictions and their pathophysiology. The mesolimbic dopaminergic system plays a major role in addictive behavior. The prefrontal cortex and the basolateral region of the amygdala play an important role in the craving and may cause relapse in subjects. In subjects with sexual addiction, only one controlled study has been conducted on the role of antidepressant treatment in the reduction of craving. The objective of the study is not only to evaluate the efficacy of tDCS neurostimulation in this disorder but also to identify the brain structures involved in this addictive disorder.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: October 1, 2024
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 18-60 year old male
• Heterosexual
• Right-handed (Manual laterality test)
• With a sexual addiction (PEACCE Tool> 3 and Carnes = 13/25) except for controls
• Having signed a written and informed consent
• Subject benefiting from social security

Exclusion Criteria:

• Subject presenting a medical pathology requiring drug treatment,
• Severe psychiatric pathology (bipolar disorder, hyperactivity or schizophrenia) or another addiction (alcohol, illicit substances or behavioral addiction)
• Subject consuming psychotropic drugs in progress or during the last month
• Subject not understanding French
• Subject under tutorship or curatorship
• Subjects with neurological disease including epilepsy or a history of head trauma
• Subjects hospitalized in enforced hospitalization
• Subject presenting a contraindication to tDCS: subject with an electrical or metal brain implant
• Subject with a contraindication to MRI

Related Conditions & MeSH terms

• Behavior, Addictive
• Sexual Addiction

Intervention

Device:
• Active Trans-cranial direct current stimulation (tDCS)
5 active sessions (1/day for 5 consecutive days) of tDCS (NeuroConn DC), active anode 8cm2 on right dorso-lateral prefrontal cortex and neutral cathode, 2 mA, during 30 min will be performed
• Sham Trans-cranial direct current stimulation (tDCS)
5 placebo sessions (1/day for 5 consecutive days) of sham tDCS (NeuroConn DC), anode 8cm2 on right dorso-lateral prefrontal cortex and neutral cathode during 30min will be performed

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier St Anne

References & Publications (6)

Garcia FD, Thibaut F. Sexual addictions. Am J Drug Alcohol Abuse. 2010 Sep;36(5):254-60. doi: 10.3109/00952990.2010.503823. Review. — View Citation

Malandain L, Blanc JV, Ferreri F, Thibaut F. Pharmacotherapy of Sexual Addiction. Curr Psychiatry Rep. 2020 May 7;22(6):30. doi: 10.1007/s11920-020-01153-4. Review. — View Citation

Rosenberg KP, Carnes P, O'Connor S. Evaluation and treatment of sex addiction. J Sex Marital Ther. 2014;40(2):77-91. doi: 10.1080/0092623X.2012.701268. Epub 2013 Jun 21. Review. — View Citation

Volkow ND, Wang GJ, Fowler JS, Tomasi D, Telang F. Addiction: beyond dopamine reward circuitry. Proc Natl Acad Sci U S A. 2011 Sep 13;108(37):15037-42. doi: 10.1073/pnas.1010654108. Epub 2011 Mar 14. Review. — View Citation

Voon V, Mole TB, Banca P, Porter L, Morris L, Mitchell S, Lapa TR, Karr J, Harrison NA, Potenza MN, Irvine M. Neural correlates of sexual cue reactivity in individuals with and without compulsive sexual behaviours. PLoS One. 2014 Jul 11;9(7):e102419. doi: 10.1371/journal.pone.0102419. eCollection 2014. — View Citation

Wainberg ML, Muench F, Morgenstern J, Hollander E, Irwin TW, Parsons JT, Allen A, O'Leary A. A double-blind study of citalopram versus placebo in the treatment of compulsive sexual behaviors in gay and bisexual men. J Clin Psychiatry. 2006 Dec;67(12):1968-73. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of tDCS in treatment of craving of sexual addiction	The primary outcome is to assess the effectiveness of tDCS treatment on the reduction of the craving by comparing before and after active tDCS stimulation in response to erotic-pornographic images.; Efficacy will be quantified by a sexual craving scale associated with erotico-pornographic images before and after tDCS stimulation.; A significant decrease in craving and score on the scale is expected after tDCS stimulation. compared to control subjects. Images of social and neutral interactions will be used as comparison of expected changes.; The scale used is the PATHOS scale: brief sexual addiction screening questionnaire.	3 years
Primary	Efficacy of tDCS in treatment of sexual addiction in subjective emotional response	For the evaluation of efficacy of tDCS in emotional response, indirect measurement of craving, visual emotional responses scales (Likert) will be used during visualization of erotico-pornographic images, before and after stimulation. The "desire" will be quantified on a Likert scale from 0 to 7.	3 years
Primary	Efficacy of tDCS in treatment of sexual addiction in objective emotional response	An assessment of emotional responses will also be done using heart rate measure during visualization of images in fMRI, before and after stimulation by tDCS	3 years
Secondary	Brain structures involved in sexual addiction	The secondary objectives are the evaluation of the brain structures involved in sexual addiction, especially craving, and the study of the modifications of the circuits involved after the application of tDCS.; A modification of the BOLD signal in fMRI in the mesolimbic reward system as well as in the dorsolateral prefrontal cortex, orbitofrontal cortex and the amygdala in response to erotic images is expected after tDCS. 50 patients with sexual addiction will be compared with 25 healthy subjects for this objective	3 years
Secondary	Evaluation of Impulsivity with The Barratt Impulsiveness Scale	In addition, the evaluation of impulsivity and inhibition capacities of the frontal cortex will be conducted.Changes in impulsivity scale scores and motor inhibition task scores are expected after tDCS.	3 years
Secondary	Evaluation of Impulsivity with UPPS-P Impulsive Behavior Scale	A decrease in scores on this scale is expected after stimulation compared to patients who received placebo stimulation.	3 years
Secondary	Evaluation Evaluation of Impulsivity with Stop Signal Task	A decrease in scores on this scale is expected after stimulation, compared to patients who received placebo stimulation.	3 years