Nicotine Use DisorderNCT03264755
Cortical Excitability and Role of rTMS in Nicotine Use Disorder
A study testing Repetitive transcranial magnetic stimulation in people with Nicotine Use Disorder, run by Assiut University.
Trial summary
Cortical excitability and role of repetitive transcranial magnetic stimulation in nicotine use disorder. Estimation of cortical excitability in heavy smoker patients and determination of role of repetitive transcranial magnetic stimulation for reducing nicotine craving. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Nicotine Use Disorder
- What is being tested?
- Repetitive transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 4 May 2020to 4 Dec 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1 )patients must be 18 to 50 years of age. 2) heavy smokers (daily cigarettes consumption of more than 20 pieces.)
Who cannot join
- cardiac pacemaker.
- metal implants in the head.
- Renal diseases
Trial locations and contacts
No sites are listed yet.
About this study
Cortical excitability and role of repetitive transcranial magnetic stimulation in nicotine use disorder. Estimation of cortical excitability in heavy smoker patients and determination of role of repetitive transcranial magnetic stimulation for reducing nicotine craving.
Read the detailed description
Nicotine is one of the main components of cigarettes and affects the central nervous system mainly via nicotinic acetylcholine receptors. It has further effects on neuromodulation by regulating the release of dopamine, serotonin, glutamate and adrenaline. In studies, it has been shown that nicotine improves attention and working memory in animals and humans, while nicotine withdrawal leads to reduced working and verbal memory capacity in otherwise healthy tobacco smokers. In schizophrenics and patients suffering from attention deficit hyperactivity disorder, nicotine improves cognitive performance. A likely basis of the nicotinic effects on cognitive functions is its effect on cortical excitability and activity. Here, neurophysiological studies mainly base on animal experiments and have shown in vitro that the nicotinic acetylcholine receptors elicit neuronal depolarisation by inducing transmembrane cationic inward currents (Calcium), thus being involved in induction and modulation of neuroplasticity and cortical excitability.
Repetitive transcranial magnetic stimulation: is a non-invasive brain stimulation technique that has shown positive results in the treatment of depression, schizophrenia, and more recently addiction. Repetitive transcranial magnetic stimulation uses alternating magnetic fields to induce electric currents in the cortical tissue. Low-frequency as one hertz repetitive transcranial magnetic stimulation is believed to inhibit neuronal firing in a localized area and is used to induce virtual brain lesions. High-frequency as more than three hertz repetitive transcranial magnetic stimulation is believed to be excitatory in nature and can result in neuronal depolarization under the stimulating coil. However, the effects of repetitive transcranial magnetic stimulation are not limited to the site of stimulation and can induce changes in distant interconnected sites of the brain, and consequently may influence subcortical regions.
- Conditions
- Nicotine Use Disorder
- Being tested
- Repetitive transcranial magnetic stimulation
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive transcranial magnetic stimulationDevice
Repetitive transcranial magnetic stimulation for cortical excitability in smokers and non smokers
| Study group | Role | What they receive |
|---|---|---|
| cortical excitability in smokers | Active comparator | Not described Receives: Device: Repetitive transcranial magnetic stimulation |
| cortical excitability in nonsmokers | Active comparator | Not described Receives: Device: Repetitive transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of cortical excitability between smoker and non smoker
Comparison of cortical excitability between smoker and non smoker :The primary motor cortex served as model, and cortical excitability was monitored via transcranial magnetic stimulation (TMS).
Measured: 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study start4 May 2020 (estimated)
- Primary completion4 Dec 2020 (estimated)
- Study completion4 Dec 2020 (estimated)
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 Nicotine Use DisorderStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Moheb, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03264755
- Sponsor's protocol ID
- CEARORINUD
- Status last verified
- Sep 2019
- First submitted
- 23 Aug 2017
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Abdelrahman AA, Noaman M, Fawzy M, Moheb A, Karim AA, Khedr EM. A double-blind randomized clinical trial of high frequency rTMS over the DLPFC on nicotine dependence, anxiety and depression. Sci Rep. 2021 Jan 15;11(1):1640. doi: 10.1038/s41598-020-80927-5.
PubMed 33452340
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cortical Excitability and Role of rTMS in Nicotine Use Disorder
- ClinicalTrials.gov ID
- NCT03264755
- Acronym / sponsor ID
- CEARORINUD
- Conditions
- Nicotine Use Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 4 May 2020 (estimated)
- Primary completion
- 4 Dec 2020 (estimated)
- Study completion
- 4 Dec 2020 (estimated)
- First posted
- 29 Aug 2017 (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.
Cortical excitability and role of repetitive transcranial magnetic stimulation in nicotine use disorder. Estimation of cortical excitability in heavy smoker patients and determination of role of repetitive transcranial magnetic stimulation for reducing nicotine craving.
Detailed description
Nicotine is one of the main components of cigarettes and affects the central nervous system mainly via nicotinic acetylcholine receptors. It has further effects on neuromodulation by regulating the release of dopamine, serotonin, glutamate and adrenaline. In studies, it has been shown that nicotine improves attention and working memory in animals and humans, while nicotine withdrawal leads to reduced working and verbal memory capacity in otherwise healthy tobacco smokers. In schizophrenics and patients suffering from attention deficit hyperactivity disorder, nicotine improves cognitive performance. A likely basis of the nicotinic effects on cognitive functions is its effect on cortical excitability and activity. Here, neurophysiological studies mainly base on animal experiments and have shown in vitro that the nicotinic acetylcholine receptors elicit neuronal depolarisation by inducing transmembrane cationic inward currents (Calcium), thus being involved in induction and modulation of neuroplasticity and cortical excitability.
Repetitive transcranial magnetic stimulation: is a non-invasive brain stimulation technique that has shown positive results in the treatment of depression, schizophrenia, and more recently addiction. Repetitive transcranial magnetic stimulation uses alternating magnetic fields to induce electric currents in the cortical tissue. Low-frequency as one hertz repetitive transcranial magnetic stimulation is believed to inhibit neuronal firing in a localized area and is used to induce virtual brain lesions. High-frequency as more than three hertz repetitive transcranial magnetic stimulation is believed to be excitatory in nature and can result in neuronal depolarization under the stimulating coil. However, the effects of repetitive transcranial magnetic stimulation are not limited to the site of stimulation and can induce changes in distant interconnected sites of the brain, and consequently may influence subcortical regions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cortical excitability in smokers | Active comparator | Device: Repetitive transcranial magnetic stimulation |
| cortical excitability in nonsmokers | Active comparator | Device: Repetitive transcranial magnetic stimulation |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1 )patients must be 18 to 50 years of age. 2) heavy smokers (daily cigarettes consumption of more than 20 pieces.)
Key exclusion criteria (3 listed)
- cardiac pacemaker.
- metal implants in the head.
- Renal diseases
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 |
|---|---|---|
| Repetitive transcranial magnetic stimulationRepetitive transcranial magnetic stimulation for cortical excitability in smokers and non smokers | Device | cortical excitability in nonsmokers, cortical excitability in smokers |
Primary outcome
Comparison of cortical excitability between smoker and non smoker
Time frame: 24 month
Comparison of cortical excitability between smoker and non smoker :The primary motor cortex served as model, and cortical excitability was monitored via transcranial magnetic stimulation (TMS).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
- Derived from this study: PubMed 33452340Abdelrahman AA, Noaman M, Fawzy M, Moheb A, Karim AA, Khedr EM. A double-blind randomized clinical trial of high frequency rTMS over the DLPFC on nicotine dependence, anxiety and depression. Sci Rep. 2021 Jan 15;11(1):1640. doi: 10.1038/s41598-020-80927-5.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive transcranial magnetic stimulation in people with Nicotine Use Disorder, run by Assiut University.
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 1 inclusion and 3 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 10 Mar 2020. 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. 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 Ahmed Abdel Bakay, Assistant prof (01096477803, ahmedbaki2020@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of cortical excitability between smoker and non smoker (time frame: 24 month). 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 NCT03264755, 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 10 Mar 2020.