Sexual Addiction Clinical Trial
— CASOfficial title:
Transcranial Electrical Stimulation in Sexual Addiction: an Innovative Treatment for a Better Understanding of the Physiopathology of Craving
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.
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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Centre Hospitalier St Anne |
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
Type | Measure | Description | Time frame | Safety issue |
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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 |
Status | Clinical Trial | Phase | |
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