Schizophrenia and Other Psychotic DisordersNCT04700930
CBD Cigarettes Instead of Normal Cigarettes as Innovative Treatment for Schizophrenia
A study testing CBD-Cigarettes in people with Schizophrenia and Other Psychotic Disorders and Harm Reduction, run by Psychiatric Hospital of the University of Basel at 1 site in Switzerland.
Trial summary
Interventional study using Cannabidiol containing cigarettes as replacement of usual cigarettes Reduction of enforcement measures, improved acute treatment, harm reduction, and improvement of psychotic symptoms Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia and Other Psychotic Disorders, Harm Reduction
- What is being tested?
- CBD-Cigarettes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteSwitzerland
- Study dates
- 4 Oct 2018to 31 Oct 2021
- 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
- Diagnosis of Schizophrenia or Related Disorders
- PANNS > 21,
- Tobacco-smokers
- inpatient status
- within age 18 - 65 years
- German-speaking
Who cannot join
- personality disorder
- non-smokers
- organic psychotic diseases
- breast feeding
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CBD Cigarettes Instead of Normal Cigarettes Against Enforcement Measures, for Improved Acute Treatment and for Harm Reduction of Smoking - Innovative Treatment for Schizophrenia
Interventional study using Cannabidiol containing cigarettes as replacement of usual cigarettes
Reduction of enforcement measures, improved acute treatment, harm reduction, and improvement of psychotic symptoms
- Being tested
- CBD-Cigarettes
- Medical subject headings
- Schizophrenia, Harm Reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBD-CigarettesOther
CBD-Cigarettes instead of normal Cigarettes: The participants in this arm receive CBD-Cigarettes which are then inhaled/smoked instead of their normal tobacco cigarettes
| Study group | Role | What they receive |
|---|---|---|
| CBD | Experimental | Patients receive CBD cigarettes additionally to standard psychiatric care including neuroleptic medication Receives: Other: CBD-Cigarettes |
| Non-CBD | No intervention | Patients recieve standard psychiatric care including neuroleptic medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in psychotic symptoms
To measure changes in psychotic symptoms weekly PANNS (Positive and Negative Syndrome Scales) are used. This is a validated medical scale used for measuring symptom severity of patients with schizophrenia. The patient is rated from 1 to 7 on 30 different symptoms based on a clinical interview. Minimum Score = 30, Maximum Score = 210 Points. Lower Scores mean less positive / less negative / less general psychopathological symptoms, which is better. Higher scores mean more postive / negativ / general psychopathological symptoms.
Measured: 1 Months (acute therapy), 6 Months (Follow up)
Change in violent behaviour.
Violent behaviour will be assessed through clinical staff via the The Brøset Violence Checklist. It is a clinical evaluation indicating the presence or absence of violent behaviour. The scale consists of 6 items. Minimum score = 0, Maximum score = 6. The lower the score, the better. A low score indicates a lower potential of violent behaviour and lower actual violent behaviour.
Measured: 1 Month (acute therapy), 6 Months (Follow up)
Change in depressive Symptoms
To measure changes in depressive Symptoms weekly BDI-II (Becks Depression Inventory) will be conducted (minimum = 0 points, maximum = 63 points). A higher score means more severe depression.
Measured: 1 Month (acute therapy), 6 Months (Follow up)
Change in subjective well being under neuroleptic medication
Subjective Well-Being under Neuroleptics Scale short form (SWN-K) will be used to assess individual well-being on a weekly basis. (Minimum = 20, Maximum = 120 points). Higher scores mean higher subjective well-being.
Measured: 1 Month (acute therapy), 6 Months (Follow up)
Change of necessary neuroleptic medication
We will register the patients neuroleptic medication. For the conversion of the participants' antipsychotic medication the Defined Daily Dose method by Leucht et al. (2016) was applied. Each participants' antipsychotic medication was converted to olanzapine equivalents in mg per day using the antipsychotic dose conversion calculator provided by Leucht and colleagues (Leucht et al., 2020).
Measured: 1 Month (acute therapy), 6 Months (Follow up)
Secondary outcomes (5)
Total number of Isolation-Events (enforcement measures)
The total number of necessary Isolations of participants in CBD-arm and non-CBD-arm will be compared. The total number of actual isolation events will be compared
Measured: 1 Month (acute therapy), 6 Months (Follow up)
Total number of enforced medication-events (enforcement measures)
The number of necessary events of enforced medication of participants in CBD-arm and non-CBD-arm will be compared. The total number of actual enforced medication-events will be compared.
Measured: 1 Month (acute therapy), 6 Months (Follow up)
Tobacco use
Number of normal tobacco cigarettes and CBD-Cigarettes will be measured by a daily self-reporting-scale of the participants.
Measured: 1 Month (acute therapy), 6 Months (Follow up)
Cannabis use
Number of cannabis-joints will be measured by weekly self-reports of the participants.
Measured: 1 Month (acute therapy), 6 Months (Follow up)
Correlation of CBD and THC levels with psychotic symptoms via PANSS
The study aims to correlate CBD and THC whole blood levels with psychotic symptoms via PANSS scores.
Measured: 1 Month (acute therapy), 6 Months (Follow up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start4 Oct 2018
- Primary completion31 Oct 2021 (estimated)
- Study completion31 Oct 2021 (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 Schizophrenia and Other Psychotic DisordersStudies 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
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Psychiatric Hospital of the University of Basel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Stefan Borgwardt, Psychiatric Hospital of the University of Basel
- Investigators
- Undine Lang, Prof. Dr., Principal investigator, Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04700930
- Sponsor's protocol ID
- 2018-01111
- Other IDs
- 2018
- Status last verified
- Jun 2021
- First submitted
- 21 Sep 2020
- Last updated
- 23 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kock P, Lang E, Trulley VN, Dechent F, Mercer-Chalmers-Bender K, Frei P, Huber C, Borgwardt S. Cannabidiol Cigarettes as Adjunctive Treatment for Psychotic Disorders - A Randomized, Open-Label Pilot-Study. Front Psychiatry. 2021 Nov 4;12:736822. doi: 10.3389/fpsyt.2021.736822. eCollection 2021.
PubMed 34803760
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CBD Cigarettes Instead of Normal Cigarettes Against Enforcement Measures, for Improved Acute Treatment and for Harm Reduction of Smoking - Innovative Treatment for Schizophrenia
- ClinicalTrials.gov ID
- NCT04700930
- Acronym / sponsor ID
- 2018-01111
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Psychiatric Hospital of the University of BaselUniversity, hospital or other
- Study start
- 4 Oct 2018 (actual)
- Primary completion
- 31 Oct 2021 (estimated)
- Study completion
- 31 Oct 2021 (estimated)
- First posted
- 8 Jan 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.
Interventional study using Cannabidiol containing cigarettes as replacement of usual cigarettes
Reduction of enforcement measures, improved acute treatment, harm reduction, and improvement of psychotic symptoms
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBD | Experimental | Other: CBD-CigarettesPatients receive CBD cigarettes additionally to standard psychiatric care including neuroleptic medication |
| Non-CBD | No intervention | –Patients recieve standard psychiatric care including neuroleptic medication |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of Schizophrenia or Related Disorders
- PANNS > 21,
- Tobacco-smokers
- inpatient status
- within age 18 - 65 years
Key exclusion criteria (5 listed)
- personality disorder
- non-smokers
- organic psychotic diseases
- breast feeding
- pregnancy
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 |
|---|---|---|
| CBD-CigarettesCBD-Cigarettes instead of normal Cigarettes: The participants in this arm receive CBD-Cigarettes which are then inhaled/smoked instead of their normal tobacco cigarettes | Other | CBD |
Primary outcome
Change in psychotic symptoms
Time frame: 1 Months (acute therapy), 6 Months (Follow up)
To measure changes in psychotic symptoms weekly PANNS (Positive and Negative Syndrome Scales) are used. This is a validated medical scale used for measuring symptom severity of patients with schizophrenia. The patient is rated from 1 to 7 on 30 different symptoms based on a clinical interview. Minimum Score = 30, Maximum Score = 210 Points. Lower Scores mean less positive / less negative / less general psychopathological symptoms, which is better. Higher scores mean more postive / negativ / general psychopathological symptoms.
Change in violent behaviour.
Time frame: 1 Month (acute therapy), 6 Months (Follow up)
Violent behaviour will be assessed through clinical staff via the The Brøset Violence Checklist. It is a clinical evaluation indicating the presence or absence of violent behaviour. The scale consists of 6 items. Minimum score = 0, Maximum score = 6. The lower the score, the better. A low score indicates a lower potential of violent behaviour and lower actual violent behaviour.
Change in depressive Symptoms
Time frame: 1 Month (acute therapy), 6 Months (Follow up)
To measure changes in depressive Symptoms weekly BDI-II (Becks Depression Inventory) will be conducted (minimum = 0 points, maximum = 63 points). A higher score means more severe depression.
Change in subjective well being under neuroleptic medication
Time frame: 1 Month (acute therapy), 6 Months (Follow up)
Subjective Well-Being under Neuroleptics Scale short form (SWN-K) will be used to assess individual well-being on a weekly basis. (Minimum = 20, Maximum = 120 points). Higher scores mean higher subjective well-being.
Change of necessary neuroleptic medication
Time frame: 1 Month (acute therapy), 6 Months (Follow up)
We will register the patients neuroleptic medication. For the conversion of the participants' antipsychotic medication the Defined Daily Dose method by Leucht et al. (2016) was applied. Each participants' antipsychotic medication was converted to olanzapine equivalents in mg per day using the antipsychotic dose conversion calculator provided by Leucht and colleagues (Leucht et al., 2020).
5 secondary outcomes
Total number of Isolation-Events (enforcement measures)
Time frame: 1 Month (acute therapy), 6 Months (Follow up)
Total number of enforced medication-events (enforcement measures)
Time frame: 1 Month (acute therapy), 6 Months (Follow up)
Tobacco use
Time frame: 1 Month (acute therapy), 6 Months (Follow up)
Cannabis use
Time frame: 1 Month (acute therapy), 6 Months (Follow up)
Correlation of CBD and THC levels with psychotic symptoms via PANSS
Time frame: 1 Month (acute therapy), 6 Months (Follow up)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2021.
- Derived from this study: PubMed 34803760Kock P, Lang E, Trulley VN, Dechent F, Mercer-Chalmers-Bender K, Frei P, Huber C, Borgwardt S. Cannabidiol Cigarettes as Adjunctive Treatment for Psychotic Disorders - A Randomized, Open-Label Pilot-Study. Front Psychiatry. 2021 Nov 4;12:736822. doi: 10.3389/fpsyt.2021.736822. eCollection 2021.
- 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.
Undine Lang, Prof. Dr. principal investigator
Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBD-Cigarettes in people with Schizophrenia and Other Psychotic Disorders and Harm Reduction, run by Psychiatric Hospital of the University of Basel at 1 site in Switzerland.
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 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 23 Jun 2021. 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 Switzerland. 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. 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?
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?
Change in psychotic symptoms (time frame: 1 Months (acute therapy), 6 Months (Follow up)). The study lists 5 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 NCT04700930, 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 23 Jun 2021.