Sexual AddictionCASNCT04923451
tDCS in Treatment of Craving in Sexual Addiction
A study testing Active Trans-cranial direct current stimulation (tDCS) in people with Sexual Addiction and Hypersexualism, run by Centre Hospitalier St Anne.
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sexual Addiction, Hypersexualism
- What is being tested?
- Active Trans-cranial direct current stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2021to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
Florence Thibaut, MD-PHD contact
About this study
Official 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.
Read the detailed 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.
- Conditions
- Sexual Addiction, Hypersexualism
- Being tested
- Active Trans-cranial direct current stimulation (tDCS), Sham Trans-cranial direct current stimulation (tDCS)
- Keywords
- Sexual Addiction, Hypersexualism, Neurostimulation, tDCS, fMRI
- Medical subject headings
- Compulsive Sexual Behavior Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Trans-cranial direct current stimulation (tDCS)Device
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)Device
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
| Study group | Role | What they receive |
|---|---|---|
| Patient with sexual addiction - active stimulation | Active comparator | 25 patients with sexual addiction will be stimulated by active tDCS during 5 consecutive days Receives: Device: Active Trans-cranial direct current stimulation (tDCS) |
| Patient with sexual addiction - sham stimulation (placebo) | Sham comparator | 25 patients with sexual addiction will be stimulated by sham tDCS stimulation (placebo) during 5 consecutive days Receives: Device: Sham Trans-cranial direct current stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
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.
Measured: 3 years
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
Measured: 3 years
Secondary outcomes (4)
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
Measured: 3 years
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.
Measured: 3 years
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.
Measured: 3 years
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study start1 Jul 2021 (estimated)
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Sexual AddictionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier St AnneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Quantitative data regarding the intensity of emotional response and craving to erotic images, motor inhibition task and impulsivity will be presented in the form of frequency, mean and standard deviation (SD) calculations and compared using a 2-factor repeated measures ANOVA taking into account the fact that the patient will be compared to himself (position 1 and 2 and placebo) and to other patients using 3 kinds of images (erotic, social and neutral) with 3 types of possible stimulations. In order to analyze the fMRI data, the regions of the patient's body will be identified. in which the BOLD activity will be correlated to the attractiveness of the image. Foreach patient, the difference before and after stimulation will be calculated. There will be no intermediate analysis.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier St Anne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04923451
- Sponsor's protocol ID
- D20-P039
- Acronym
- CAS
- Status last verified
- Nov 2020
- First submitted
- 22 Mar 2021
- Last updated
- 11 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Garcia FD, Thibaut F. Sexual addictions. Am J Drug Alcohol Abuse. 2010 Sep;36(5):254-60. doi: 10.3109/00952990.2010.503823.
PubMed 20666699Malandain 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.
PubMed 32377953Wainberg 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. doi: 10.4088/jcp.v67n1218.
PubMed 17194276Volkow 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.
PubMed 21402948Voon 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.
PubMed 25013940Rosenberg 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.
PubMed 23790248
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Electrical Stimulation in Sexual Addiction: an Innovative Treatment for a Better Understanding of the Physiopathology of Craving
- ClinicalTrials.gov ID
- NCT04923451
- Acronym / sponsor ID
- CAS / D20-P039
- Conditions
- Sexual Addiction, Hypersexualism
- Keywords
- Sexual Addiction, Hypersexualism, Neurostimulation, tDCS, fMRI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centre Hospitalier St AnneUniversity, hospital or other
- Study start
- 1 Jul 2021 (estimated)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 11 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Quantitative data regarding the intensity of emotional response and craving to erotic images, motor inhibition task and impulsivity will be presented in the form of frequency, mean and standard deviation (SD) calculations and compared using a 2-factor repeated measures ANOVA taking into account the fact that the patient will be compared to himself (position 1 and 2 and placebo) and to other patients using 3 kinds of images (erotic, social and neutral) with 3 types of possible stimulations. In order to analyze the fMRI data, the regions of the patient's body will be identified. in which the BOLD activity will be correlated to the attractiveness of the image. Foreach patient, the difference before and after stimulation will be calculated. There will be no intermediate analysis.
| Arm | Type | Receives |
|---|---|---|
| Patient with sexual addiction - active stimulation | Active comparator | Device: Active Trans-cranial direct current stimulation (tDCS)25 patients with sexual addiction will be stimulated by active tDCS during 5 consecutive days |
| Patient with sexual addiction - sham stimulation (placebo) | Sham comparator | Device: Sham Trans-cranial direct current stimulation (tDCS)25 patients with sexual addiction will be stimulated by sham tDCS stimulation (placebo) during 5 consecutive days |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | Patient with sexual addiction - active stimulation |
| 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 | Device | Patient with sexual addiction - sham stimulation (placebo) |
Primary outcome
Efficacy of tDCS in treatment of craving of sexual addiction
Time frame: 3 years
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.
Efficacy of tDCS in treatment of sexual addiction in subjective emotional response
Time frame: 3 years
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.
Efficacy of tDCS in treatment of sexual addiction in objective emotional response
Time frame: 3 years
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
4 secondary outcomes
Brain structures involved in sexual addiction
Time frame: 3 years
Evaluation of Impulsivity with The Barratt Impulsiveness Scale
Time frame: 3 years
Evaluation of Impulsivity with UPPS-P Impulsive Behavior Scale
Time frame: 3 years
Evaluation Evaluation of Impulsivity with Stop Signal Task
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2021.
- Background: PubMed 20666699Garcia FD, Thibaut F. Sexual addictions. Am J Drug Alcohol Abuse. 2010 Sep;36(5):254-60. doi: 10.3109/00952990.2010.503823.
- Background: PubMed 32377953Malandain 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.
- Background: PubMed 17194276Wainberg 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. doi: 10.4088/jcp.v67n1218.
- Background: PubMed 21402948Volkow 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.
- Background: PubMed 25013940Voon 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.
- Background: PubMed 23790248Rosenberg 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florence Thibaut, MD-PHD contact
Questions about this trial
What is this clinical trial studying?
A study testing Active Trans-cranial direct current stimulation (tDCS) in people with Sexual Addiction and Hypersexualism, run by Centre Hospitalier St Anne.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leo Malandain, MD (0033158411678, leo.malandain@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of tDCS in treatment of craving of sexual addiction (time frame: 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04923451, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2021.