Cannabis Use DisorderNCT03069612
rTMS Treatment for Cannabis Use Disorders in Psychosis
A study testing Repetitive Transcranial Magnetic Stimulation (rTMS) in people with Cannabis Use Disorder and Psychosis, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
Cannabis use during adolescence represents a significant risk factor for the development of psychosis including schizophrenia. Moreover, cannabis is the most commonly used drug among patients with an existing psychotic disorder. Read more about this study
- Who is it for?
- Ages 16 to 35 years
- Conditions the study is for
- Cannabis Use Disorder, Psychosis
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation (rTMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteCanada
- Study dates
- 1 Dec 2016to 28 Aug 2017
- 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 16 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 16-35
- Meet Diagnostic and Statistical Manual for Mental Disorders (DSM)-5 diagnostic criteria for a cannabis use disorder with physiological evidence of dependence; plus one of schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, bipolar I disorder, major depressive disorder with psychotic features, cannabis-induced psychosis, or psychosis not otherwise specified
- Full scale IQ ≥ 80 determined through the Wechler Test for Adult Reading (WTAR)
- Daily cigarette smoker of ≥ 5 cigarettes per day
Who cannot join
- DSM-5 diagnoses of alcohol, substance or poly-use substance use disorder in the past 6 months (other than cannabis/caffeine or nicotine)
- Currently active suicidal ideation or self-harm (suicidal or non-suicidal)
- Head injury resulting in loss of consciousness and hospitalization
- Major neurological or medical illness including seizure disorder or syncope
- Metallic implants
- History of rTMS treatment
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Cannabis Dependence and Working Memory in Patients With Early Psychosis
Cannabis use during adolescence represents a significant risk factor for the development of psychosis including schizophrenia. Moreover, cannabis is the most commonly used drug among patients with an existing psychotic disorder. An estimated 25% of patients with psychosis reportedly meet the criteria of a cannabis use disorder particularly among younger patients experiencing their first episode. Cannabis use significantly exacerbates symptomatology resulting in an increased duration of the first hospitalization visit, number of hospital readmissions, and overall reduced functional outcome. Discovering novel strategies to treat the underlying pathophysiology of cannabis dependence early in the disorder may translate into improved functional outcome. Working memory deficits have been shown to predict relapse in the first-year of psychosis and is modulated with cannabis use. Repetitive transcranial magnetic stimulation (rTMS) targeted to the dorsolateral prefrontal cortex (DLPFC) has shown tremendous promise for the treatment of both tobacco dependence and working memory impairment in patients with psychosis possibly through the modulation of gamma (30-50 Hz) oscillations. The proposed study will therefore evaluate the effect of rTMS on abstinence, working memory performance, and gamma oscillations through a randomized, double-blind, placebo-controlled 28-day longitudinal abstinence study design in patients with early psychosis. It will further explore if baseline performance and gamma oscillations predict abstinence in response to rTMS. It is hypothesized that active compared to sham rTMS will improve abstinence rates and improve working memory performance through the modulation of gamma oscillations.
Read the detailed description
This a randomized, double-blind placebo-controlled, longitudinal 28-Day abstinence study design. Patients with psychosis will be randomized (1:1) to receive either active or sham stimulation that will be administered three times per week for 4 weeks (28 days) for a total of 12 treatments. Urine will be collected three times per week prior to the rTMS treatment. Cognition including the N-Back task and MATRICS cognitive battery will be administered on Day 0, Day 28, and Day 42 to determine the effect of rTMS on cognition compared to sham stimulation.
- Conditions
- Cannabis Use Disorder, Psychosis
- Being tested
- Repetitive Transcranial Magnetic Stimulation (rTMS)
- Keywords
- repetitive transcranial magnetic stimulation, working memory, gamma oscillations, dorsolateral prefrontal cortex
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic Stimulation (rTMS)Device
rTMS administered bilaterally to the DLPFC at 20 Hz, 90% RMT, 25 trains
| Study group | Role | What they receive |
|---|---|---|
| rTMS Active Group | Experimental | Repetitive transcranial magnetic stimulation (rTMS) will be administered bilaterally to the dorsolateral prefrontal cortex (DLPFC) at 20 Hz, 90% RMT in 25 trains. Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS) |
| rTMS Sham Group | Sham comparator | Repetitive transcranial magnetic stimulation (rTMS) will be administered bilaterally to the dorsolateral prefrontal cortex (DLPFC) at 20 Hz, 90% RMT in 25 trains with a sham coil. Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cannabis Abstinence
Gas chromatography/mass spectrometry (GC/MS) analysis to obtain quantitative THC-COOH and creatinine concentrations.
Measured: Change of COOH and creatinine concentrations.from baseline to Day 28.
Secondary outcomes (2)
Working Memory Performance
Working memory task will measure accuracy and reaction time.
Measured: Baseline, trial endpoint (Day 28) and at follow up (Day 56) for a total of 3 times.
Gamma Oscillations
Oscillatory activity will be measured through EEG while performing the working memory task.
Measured: Baseline, trial endpoint (Day 28) and at follow up (Day 56) for a total of 3 times.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study start1 Dec 2016
- Primary completion28 Aug 2017
- Study completion28 Aug 2017
Why it stopped: Terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cannabis Use DisorderStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mera Barr, Centre for Addiction and Mental Health
- Investigators
- Mera S Barr, PhD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03069612
- Sponsor's protocol ID
- 215/2016
- Status last verified
- Sep 2017
- First submitted
- 22 Feb 2017
- Last updated
- 11 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Cannabis Dependence and Working Memory in Patients With Early Psychosis
- ClinicalTrials.gov ID
- NCT03069612
- Acronym / sponsor ID
- 215/2016
- Conditions
- Cannabis Use Disorder, Psychosis
- Keywords
- repetitive transcranial magnetic stimulation, working memory, gamma oscillations, dorsolateral prefrontal cortex
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 28 Aug 2017 (actual)
- Study completion
- 28 Aug 2017 (actual)
- First posted
- 3 Mar 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.
Cannabis use during adolescence represents a significant risk factor for the development of psychosis including schizophrenia. Moreover, cannabis is the most commonly used drug among patients with an existing psychotic disorder. An estimated 25% of patients with psychosis reportedly meet the criteria of a cannabis use disorder particularly among younger patients experiencing their first episode. Cannabis use significantly exacerbates symptomatology resulting in an increased duration of the first hospitalization visit, number of hospital readmissions, and overall reduced functional outcome. Discovering novel strategies to treat the underlying pathophysiology of cannabis dependence early in the disorder may translate into improved functional outcome. Working memory deficits have been shown to predict relapse in the first-year of psychosis and is modulated with cannabis use. Repetitive transcranial magnetic stimulation (rTMS) targeted to the dorsolateral prefrontal cortex (DLPFC) has shown tremendous promise for the treatment of both tobacco dependence and working memory impairment in patients with psychosis possibly through the modulation of gamma (30-50 Hz) oscillations. The proposed study will therefore evaluate the effect of rTMS on abstinence, working memory performance, and gamma oscillations through a randomized, double-blind, placebo-controlled 28-day longitudinal abstinence study design in patients with early psychosis. It will further explore if baseline performance and gamma oscillations predict abstinence in response to rTMS. It is hypothesized that active compared to sham rTMS will improve abstinence rates and improve working memory performance through the modulation of gamma oscillations.
Detailed description
This a randomized, double-blind placebo-controlled, longitudinal 28-Day abstinence study design. Patients with psychosis will be randomized (1:1) to receive either active or sham stimulation that will be administered three times per week for 4 weeks (28 days) for a total of 12 treatments. Urine will be collected three times per week prior to the rTMS treatment. Cognition including the N-Back task and MATRICS cognitive battery will be administered on Day 0, Day 28, and Day 42 to determine the effect of rTMS on cognition compared to sham stimulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rTMS Active Group | Experimental | Device: Repetitive Transcranial Magnetic Stimulation (rTMS)Repetitive transcranial magnetic stimulation (rTMS) will be administered bilaterally to the dorsolateral prefrontal cortex (DLPFC) at 20 Hz, 90% RMT in 25 trains. |
| rTMS Sham Group | Sham comparator | Device: Repetitive Transcranial Magnetic Stimulation (rTMS)Repetitive transcranial magnetic stimulation (rTMS) will be administered bilaterally to the dorsolateral prefrontal cortex (DLPFC) at 20 Hz, 90% RMT in 25 trains with a sham coil. |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age 16-35
- Meet Diagnostic and Statistical Manual for Mental Disorders (DSM)-5 diagnostic criteria for a cannabis use disorder with physiological evidence of dependence; plus one of schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, bipolar I disorder, major depressive disorder with psychotic features, cannabis-induced psychosis, or psychosis not otherwise specified
- Full scale IQ ≥ 80 determined through the Wechler Test for Adult Reading (WTAR)
- Daily cigarette smoker of ≥ 5 cigarettes per day
Key exclusion criteria (7 listed)
- DSM-5 diagnoses of alcohol, substance or poly-use substance use disorder in the past 6 months (other than cannabis/caffeine or nicotine)
- Currently active suicidal ideation or self-harm (suicidal or non-suicidal)
- Head injury resulting in loss of consciousness and hospitalization
- Major neurological or medical illness including seizure disorder or syncope
- Metallic implants
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 Stimulation (rTMS)rTMS administered bilaterally to the DLPFC at 20 Hz, 90% RMT, 25 trains | Device | rTMS Active Group, rTMS Sham Group |
Primary outcome
Cannabis Abstinence
Time frame: Change of COOH and creatinine concentrations.from baseline to Day 28.
Gas chromatography/mass spectrometry (GC/MS) analysis to obtain quantitative THC-COOH and creatinine concentrations.
2 secondary outcomes
Working Memory Performance
Time frame: Baseline, trial endpoint (Day 28) and at follow up (Day 56) for a total of 3 times.
Gamma Oscillations
Time frame: Baseline, trial endpoint (Day 28) and at follow up (Day 56) for a total of 3 times.
Results and safety
The study was stopped early (reason given: Terminated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2017.
- Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospital, fully affiliated with the University of Toronto, and a PAHO/WHO Collaborating CentreStudy Data/Documents:Link provided by the sponsor.
- 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.
Mera S Barr, PhD principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive Transcranial Magnetic Stimulation (rTMS) in people with Cannabis Use Disorder and Psychosis, run by Centre for Addiction and Mental Health at 1 site in Canada.
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 7 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: stopped early, as of the sponsor's last update on 11 Sep 2017. 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 Canada. 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 was stopped early (reason given: Terminated). 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?
Cannabis Abstinence (time frame: Change of COOH and creatinine concentrations.from baseline to Day 28.). 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 11 Sep 2017.