Cannabis Use Disorder, ModerateEarly Phase 1NCT04106336
Cortical Excitability and Role of rTMS in Cannabis Use Disorder
A Early Phase 1 study testing rTMS in people with Cannabis Use Disorder, Moderate, run by Assiut University.
Trial summary
Repetitive transcranial magnetic stimulation (rTMS) and cortical excitability have a role in cannabis use disorder 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
- Cannabis Use Disorder, Moderate
- What is being tested?
- rTMS
- 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
- 1 Oct 2019to 30 Dec 2020
- Phase
- Early Phase 1
- 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
- 18to 50 years of age
- cannabis use disorder according to DSM 5 definition
- clear consent to participate in study
Who cannot join
- cardiac peacemaker
- metal implant in the head as participate will be applied to magnetic field of TMS
- current intake of any medication affect cognition (as anti psychotic and anti epileptic)
- current history of neurological , psychiatric or general medical disease .current or previous drug (other than cannabis )or alcohol abuse or participation in another trial during the past 8 weeks .
- age younger than 18 and older than 50 years
About this study
Repetitive transcranial magnetic stimulation (rTMS) and cortical excitability have a role in cannabis use disorder
- Conditions
- Cannabis Use Disorder, Moderate
- Being tested
- rTMS
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMSDevice
Repetitive transcranial magnetic stimulation (rTMS) will be done for cannabis addict
| Study group | Role | What they receive |
|---|---|---|
| non cannabis addict | No intervention | 30 non cannabis addict will be control group |
| cannabis addict | Active comparator | 30 cannabis addict will undergo rTMS Receives: Device: rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of role of rTMS for reducing cannabis craving
Incidenc of cannabis craving after rTMS
Measured: 1 year
Secondary outcomes (1)
Estimation of cortical excitability in cannabis addict
Incidence of cannabis craving after cortical excitability
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start1 Oct 2019 (estimated)
- Primary completion1 Oct 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cannabis Use Disorder, ModerateStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- 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, Asmaa Omar Radwan Helal, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04106336
- Sponsor's protocol ID
- rTMS in cannabis use disorder
- Status last verified
- Sep 2019
- First submitted
- 23 Sep 2019
- Last updated
- 27 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cortical Excitability and Role of rTMS in Cannabis Use Disorder
- ClinicalTrials.gov ID
- NCT04106336
- Acronym / sponsor ID
- rTMS in cannabis use disorder
- Conditions
- Cannabis Use Disorder, Moderate
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (estimated)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 27 Sep 2019 (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.
Repetitive transcranial magnetic stimulation (rTMS) and cortical excitability have a role in cannabis use disorder
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non cannabis addict | No intervention | –30 non cannabis addict will be control group |
| cannabis addict | Active comparator | Device: rTMS30 cannabis addict will undergo rTMS |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18to 50 years of age
- cannabis use disorder according to DSM 5 definition
- clear consent to participate in study
Key exclusion criteria (5 listed)
- cardiac peacemaker
- metal implant in the head as participate will be applied to magnetic field of TMS
- current intake of any medication affect cognition (as anti psychotic and anti epileptic)
- current history of neurological , psychiatric or general medical disease .current or previous drug (other than cannabis )or alcohol abuse or participation in another trial during the past 8 weeks .
- age younger than 18 and older than 50 years
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 |
|---|---|---|
| rTMSRepetitive transcranial magnetic stimulation (rTMS) will be done for cannabis addict | Device | cannabis addict |
Primary outcome
Determination of role of rTMS for reducing cannabis craving
Time frame: 1 year
Incidenc of cannabis craving after rTMS
1 secondary outcome
Estimation of cortical excitability in cannabis addict
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2019.
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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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing rTMS in people with Cannabis Use Disorder, Moderate, 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 3 inclusion and 5 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 27 Sep 2019. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Determination of role of rTMS for reducing cannabis craving (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Sep 2019.