Cocaine Use DisorderMagneToxNCT03607591
Efficacy of Repetitive Transcranial Magnetic Stimulation in Reducing Cocaine Intake in Addicted Patients
A study testing rTMS in people with Cocaine Use Disorder, run by Azienda Ospedaliero-Universitaria Careggi at 1 site in Italy.
Trial summary
The study evaluates the efficacy of 3 weeks of repetitive transcranial magnetic stimulation (rTMS), 5 sessions/weekly, in reducing cocaine consumption immediately after and within the 8 weeks following the treatment in addicted patients with cocaine use disorders (CUD) versus placebo. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cocaine Use Disorder
- What is being tested?
- rTMS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteItaly
- Study dates
- 8 Jan 2018to 1 Apr 2020
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male and female patients between 18 and 65 years of age
- patients who meet the criteria for CUD reported in the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-V)
- positivity to cocaine use, determined via an urine drug test
- patients who are able to provide a written informed consent, after being notified about the treatment and the study protocol
Who cannot join
- major depression disorder, schizophrenia, bipolar disorder or other psychosis that meet the diagnostic criteria of the DSM-V
- illiteracy or cognitive impairment disorders
- women who are pregnant or lactating
- other medical diseases that contraindicate rTMS treatment such as epilepsy
- presence of devices, i.e. pace-makers or cochlear prosthesis
- previous rTMS treatments in order to avoid confounding factors
- patients who can not provide the written informed consent
- DSM-V substance use disorders other than CUD. Only tobacco smoke is allowed to be recruited in the study protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of High Frequency (15Hz) Repetitive Transcranial Magnetic Stimulation of Left Dorsolateral Prefrontal Cortex in Decreasing Intake in Patients With Cocaine Use Disorder: Study Protocol for a Randomized Placebo Controlled Trial
The study evaluates the efficacy of 3 weeks of repetitive transcranial magnetic stimulation (rTMS), 5 sessions/weekly, in reducing cocaine consumption immediately after and within the 8 weeks following the treatment in addicted patients with cocaine use disorders (CUD) versus placebo.
Read the detailed description
40 patients are expected and randomized in two groups: 20 patients with active rTMS and 20 with placebo rTMS.
Visit 1: 15 days (3 weeks of 5 consecutive daily sessions and 2 days of rest) 15Hz rTMS is performed during the following days in addition to a biweekly urine drug test and VAS evaluation.
Visit 2: Changes from baseline to week 8 in cocaine intake. Evaluation of craving and of other assessments like mood and quality of life.
- Conditions
- Cocaine Use Disorder
- Being tested
- rTMS
- Keywords
- rTMS, Craving, Mood and cognitive behavior, Substance-Related Disorders
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMSOther
rTMS is a non-invasive and safe brain stimulation technique, that uses a magnetic pulse, administrated through a coil, set on the DLPFC
| Study group | Role | What they receive |
|---|---|---|
| Active rTMS group | Active comparator | One daily session: active 15Hz frequency, pulse intensity 100% of the rTMS, 60 pulses per train, inter-train pause of 15 sec, 40 stimulation trains for a total of 2400 pulses in 13 min of stimulation). 15 sessions (3 weeks of 5 consecutive daily sessions and 2 days of rest) Receives: Other: rTMS |
| Placebo rTMS group | Placebo comparator | One daily session: inactive 15Hz frequency, pulse intensity 100% of the rTMS, 60 pulses per train, inter-train pause of 15 sec, 40 stimulation trains for a total of 2400 pulses in 13 min of stimulation). 15 sessions (3 weeks of 5 consecutive daily sessions and 2 days of rest) Receives: Other: rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cocaine intake
Baseline was defined as cocaine consumption before randomization (visit 0). Baseline will be determined using an urine drug test.Changes from baseline to week 8 in cocaine intake
Measured: 8 weeks following the treatment
Secondary outcomes (2)
Craving first measure
Baseline will be determined using the Visual Analogic Scale (VAS) that is a ordinal scale ranging from 0 to 10. being 0 no craving and 10 maximum craving. Changes from baseline to 8 week
Measured: 8 weeks following the treatment
Craving second measure
Baseline will be assessed using Cocaine Craving Questionnaire (CCQ), that is a ordinal scale ranging from 0 and 45, being 0 no craving and 45 maximum craving.
Measured: 8 weeks following the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start8 Jan 2018
- Primary completion1 Apr 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cocaine Use DisorderStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria Careggi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonello Grippo, Azienda Ospedaliero-Universitaria Careggi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03607591
- Sponsor's protocol ID
- CEAVC SPE 16.309
- Acronym
- MagneTox
- Status last verified
- Jul 2020
- First submitted
- 13 Apr 2018
- Last updated
- 9 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lolli F, Salimova M, Scarpino M, Lanzo G, Cossu C, Bastianelli M, Occupati B, Gori F, Del Vecchio A, Ercolini A, Pascolo S, Cimino V, Meneghin N, Fierini F, D'Anna G, Innocenti M, Ballerini A, Pallanti S, Grippo A, Mannaioni G. A randomised, double-blind, sham-controlled study of left prefrontal cortex 15 Hz repetitive transcranial magnetic stimulation in cocaine consumption and craving. PLoS One. 2021 Nov 16;16(11):e0259860. doi: 10.1371/journal.pone.0259860. eCollection 2021.
PubMed 34784373
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of High Frequency (15Hz) Repetitive Transcranial Magnetic Stimulation of Left Dorsolateral Prefrontal Cortex in Decreasing Intake in Patients With Cocaine Use Disorder: Study Protocol for a Randomized Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT03607591
- Acronym / sponsor ID
- MagneTox / CEAVC SPE 16.309
- Conditions
- Cocaine Use Disorder
- Keywords
- rTMS, Craving, Mood and cognitive behavior, Substance-Related Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Azienda Ospedaliero-Universitaria CareggiUniversity, hospital or other
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 31 Jul 2018 (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.
The study evaluates the efficacy of 3 weeks of repetitive transcranial magnetic stimulation (rTMS), 5 sessions/weekly, in reducing cocaine consumption immediately after and within the 8 weeks following the treatment in addicted patients with cocaine use disorders (CUD) versus placebo.
Detailed description
40 patients are expected and randomized in two groups: 20 patients with active rTMS and 20 with placebo rTMS.
Visit 1: 15 days (3 weeks of 5 consecutive daily sessions and 2 days of rest) 15Hz rTMS is performed during the following days in addition to a biweekly urine drug test and VAS evaluation.
Visit 2: Changes from baseline to week 8 in cocaine intake. Evaluation of craving and of other assessments like mood and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active rTMS group | Active comparator | Other: rTMSOne daily session: active 15Hz frequency, pulse intensity 100% of the rTMS, 60 pulses per train, inter-train pause of 15 sec, 40 stimulation trains for a total of 2400 pulses in 13 min of stimulation). 15 sessions (3 weeks of 5 consecutive daily sessions and 2 days of rest) |
| Placebo rTMS group | Placebo comparator | Other: rTMSOne daily session: inactive 15Hz frequency, pulse intensity 100% of the rTMS, 60 pulses per train, inter-train pause of 15 sec, 40 stimulation trains for a total of 2400 pulses in 13 min of stimulation). 15 sessions (3 weeks of 5 consecutive daily sessions and 2 days of rest) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- male and female patients between 18 and 65 years of age
- patients who meet the criteria for CUD reported in the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-V)
- positivity to cocaine use, determined via an urine drug test
- patients who are able to provide a written informed consent, after being notified about the treatment and the study protocol
Key exclusion criteria (8 listed)
- major depression disorder, schizophrenia, bipolar disorder or other psychosis that meet the diagnostic criteria of the DSM-V
- illiteracy or cognitive impairment disorders
- women who are pregnant or lactating
- other medical diseases that contraindicate rTMS treatment such as epilepsy
- presence of devices, i.e. pace-makers or cochlear prosthesis
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 |
|---|---|---|
| rTMSrTMS is a non-invasive and safe brain stimulation technique, that uses a magnetic pulse, administrated through a coil, set on the DLPFC | Other | Active rTMS group, Placebo rTMS group |
Primary outcome
Cocaine intake
Time frame: 8 weeks following the treatment
Baseline was defined as cocaine consumption before randomization (visit 0). Baseline will be determined using an urine drug test.Changes from baseline to week 8 in cocaine intake
2 secondary outcomes
Craving first measure
Time frame: 8 weeks following the treatment
Craving second measure
Time frame: 8 weeks following the treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2020.
- Derived from this study: PubMed 34784373Lolli F, Salimova M, Scarpino M, Lanzo G, Cossu C, Bastianelli M, Occupati B, Gori F, Del Vecchio A, Ercolini A, Pascolo S, Cimino V, Meneghin N, Fierini F, D'Anna G, Innocenti M, Ballerini A, Pallanti S, Grippo A, Mannaioni G. A randomised, double-blind, sham-controlled study of left prefrontal cortex 15 Hz repetitive transcranial magnetic stimulation in cocaine consumption and craving. PLoS One. 2021 Nov 16;16(11):e0259860. doi: 10.1371/journal.pone.0259860. eCollection 2021.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rTMS in people with Cocaine Use Disorder, run by Azienda Ospedaliero-Universitaria Careggi at 1 site in Italy.
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 4 inclusion and 8 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: finished, as of the sponsor's last update on 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cocaine intake (time frame: 8 weeks following the treatment). 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 NCT03607591, which also lists 1 linked publication.
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 9 Jul 2020; AzTrials last refreshed its copy on 8 Nov 2026.