Cannabis Use DisorderiCCNCT05310981
A Cannabis E-intervention for Young Cannabis Users With Early Psychosis (iCC)
A study testing iCanChange in people with Cannabis Use Disorder, run by Centre hospitalier de l'Université de Montréal (CHUM) at 5 sites in Canada.
Trial summary
The concerning lack of research related to technology-based psychological interventions in individuals with psychosis and cannabis use disorder (CUD) led to the design a randomized control trial (RCT) with an innovative mobile health e-intervention called ICanChange (iCC). Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Cannabis Use Disorder
- What is being tested?
- iCanChange
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 5 sitesCanada
- Study dates
- 6 Jul 2022to 31 Jul 2024
- 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 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants must meet all of the following criteria:
- Young adults age 18 to 35 years old
- Diagnosed with any psychotic disorder, which can include schizophrenia, schizoaffective disorder, bipolar disorder with psychotic features, delusional disorder, psychotic disorder not otherwise specified, brief psychotic disorder and substance-induced psychotic disorder.
- Has been followed at an early psychosis clinic for a minimum of 3 months
- Diagnosed with a current CUD (any severity), based on Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria
- Currently using cannabis (used cannabis at least once in the past month)
Show all 10Show fewer
- Accepting an intervention for CUD to cease or decrease his/her use
- Able to provide full informed consent
- Available for the whole duration of the study/able to comply with study procedures
- Able to comprehend French or English
Who cannot join
- Any medical condition that in the opinion of the psychiatrist precludes safe participation in the study or the ability to provide fully informed consent
- Any disabling, unstable or acute mental condition that in the opinion of the psychiatrist precludes safe participation in the study or the ability to provide fully informed consent
- Any legal/judicial status/issue, pending legal action, or other reasons in the opinion of the study team that might prevent completion of the study
- Presence of an additional substance use disorder that, in the opinion of the psychiatrist, precludes safe participation in the study (e.g., very unstable or severe substance use disorder)
- Currently participating in another specific cannabis use-focused intervention (other than those which are part of the intervention and control arms)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
Foothills Medical Centre Early Psychosis Intervention Program
Calgary, Alberta, T2N2T9
Nova Scotia Early Psychosis Program
Halifax, Nova Scotia, B3H2E2
Clinic Connec-T - Institut universitaire en santé mentale de Montréal
Montreal, Quebec, H1N3M5
Clinique JAP, Centre hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 3E4
Clinic Notre-Dame des Victoires - Centre de Recherche CERVO
Québec, Quebec, G1J2G3
About this study
Official title: A Randomized Pilot Trial of ICanChange, a Mobile Health Intervention to Reduce Cannabis Use in Young Adults With Psychosis
The concerning lack of research related to technology-based psychological interventions in individuals with psychosis and cannabis use disorder (CUD) led to the design a randomized control trial (RCT) with an innovative mobile health e-intervention called ICanChange (iCC). Randomized control trials (RCTs) on well-defined samples (limited to psychosis and CUD) are needed to generate evidence on e-health interventions in individuals with psychosis and CUD. As such, an RCT will be conducted to assess the acceptability and feasibility of administering this e-intervention to young people with psychosis who use cannabis. Besides having scarce cannabis interventions adapted for people with psychosis, there are other barriers to addressing problematic cannabis use, such as the challenging and inadequate access to mental health and substance use services by this population. Implementing these and other approaches in the context of a harm reduction intervention or applying other strategies seeking to minimize cannabis-related harms for people who wish to continue using cannabis may be key in helping individuals set realistic goals that are important and relevant to them.
Read the detailed description
This is a multi-site, two-arm, open-label, pilot randomized control trial, involving 100 young adults diagnosed with psychosis and cannabis use disorder (CUD). Participants will be randomly assigned to either:
Arm 1. Early intervention services (EIS): early intervention for psychosis, including standard of care for psychosis and CUD following Canadian guidelines.
Arm 2. iCC + modified EIS (mEIS): The iCC is an application-based intervention that includes psychotherapeutic modules based on Motivational Interviewing (MI) and Cognitive Behavioral Therapy (CBT). Participants in this arm also receive the same services as in EIS, excluding formal psychotherapeutic interventions for CUD.
Participants will complete assessments at baseline, and at 6, 12, and 24 weeks from baseline.
- Conditions
- Cannabis Use Disorder
- Being tested
- iCanChange
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iCanChangeBehavioural
iCC is a psychological app based intervention that will be delivered in form of up to 24 brief (10-15 minutes) interactive modules developed based on the principles of Motivational Interviewing (MI) and Cognitive Behavioural Therapy (CBT). During the intervention, participants will be offered MI and CBT-based activities (i.e., modules and strategies) aiming at facilitating change in cannabis use. At any point during the intervention, participants can reference modules that had been completed. Due to the frequency of behavioral stage changes in this population (e.g., regression in behavioral stage of change), stage of change will be monitored regularly throughout the intervention. During the follow-up period (i.e., Week 12-24), participants will have continuous access to the smart phone application and all built-in add-ons as described above. During this period, they will have access to 3 booster session.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: CHAMPS and mEIS | Experimental | Brief mobile application-based psychological intervention based on the principles of motivational interviewing (MI) and cognitive behavioural therapy (CBT). This e-intervention will be completed by the participant using a smart phone. There will be up to a maximum of 24 individual sessions (which includes 3 booster sessions) each lasting approximately 10-15 minutes.
mEIS: iCC will be administered adjunctively to modified EIS (mEIS), which will include all interventions usually provided through EIS except for any specific psychological interventions (MI, CBT, contingency management) for CUD. Receives: Behavioral: iCanChange |
| No Intervention: EIS alone | No intervention | Early intervention services will be offered as per standard of care following EIS for psychosis and CUD guidelines, at participating clinical sites. Any visits and services offered in control arm will be considered 'usual care' and administered either through in-person clinic visits, community visits, phone calls, or video calls. Relevant service information will be collected for study purposes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion rates
Number of participants who completed the first section of the intervention and at least one module from section 2 related to achieving their cannabis consumption objectives or with ongoing participation in EIS.
Measured: Week 12
Retention rates
Proportions of participants retained in the trial (completing all endpoint assessments)
Measured: Week 12
Secondary outcomes (4)
Acceptability (iCC usage data)
Number of iCC modules completed, time spent on each module, time elapsed between module initiation and completion, total time spent on iCC.
Measured: Weeks 0-24
Participant satisfaction
Score on the Client Satisfaction Questionnaire-I (CSQ-I). The CSQ-I is a modified version of the CSQ-8 measuring global satisfaction with a web-based intervention and and provider reports. Items are scored from 1= "does not apply to me" to 4= "Does totally apply to me". The scores for all eight items will be summed for a total score in the range 8 to 32. To calculate scores on the CSQ-I, sum item responses (range from 8-32). Higher scores indicate higher satisfaction. This collects information on the participant's satisfaction as it relates to the assigned cannabis-focused intervention.
Measured: Weeks 6, 12 & 24
Trial parameters
Numbers of participants who are referred, screened, eligible, consenting, randomized, initiating and completing the study
Measured: Week -4 to Week 24
Cannabis Use
Frequency and quantity of cannabis use in the last 14 days will be measured using the Timeline Follow Back (TLFB) which is a tool that captures self-reported drug use. The TLFB will assess the frequency of cannabis use, the self-reported days with abstinence from cannabis weekly, as well as type of cannabis products, quantity and dose/concentration in cannabinoids.
Measured: (-2-0 (baseline) and Week 6, 12 & 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start6 Jul 2022
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
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 Cannabis 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two-arm parallel, open-labelled, pilot randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
- Sponsor type
- University, hospital or other
- Collaborators
- Ministere de la Sante et des Services Sociaux
- Responsible party
- Sponsor
- Investigators
- Didier Jutras-Aswad, MD, MSc, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05310981
- Sponsor's protocol ID
- 21.310
- Acronym
- iCC
- Status last verified
- Dec 2025
- First submitted
- 3 Feb 2022
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized data sharing procedure will be made developed and made available after completion of the study.
Publications
Tatar O, Abdel-Baki A, Wittevrongel A, Lecomte T, Copeland J, Lachance-Touchette P, Coronado-Montoya S, Cote J, Crockford D, Dubreucq S, L'Heureux S, Ouellet-Plamondon C, Roy MA, Tibbo PG, Villeneuve M, Jutras-Aswad D. Reducing Cannabis Use in Young Adults With Psychosis Using iCanChange, a Mobile Health App: Protocol for a Pilot Randomized Controlled Trial (ReCAP-iCC). JMIR Res Protoc. 2022 Nov 25;11(11):e40817. doi: 10.2196/40817.
PubMed 36427227
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Pilot Trial of ICanChange, a Mobile Health Intervention to Reduce Cannabis Use in Young Adults With Psychosis
- ClinicalTrials.gov ID
- NCT05310981
- Acronym / sponsor ID
- iCC / 21.310
- Conditions
- Cannabis Use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- Ministere de la Sante et des Services Sociaux
- Study start
- 6 Jul 2022 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 5 Apr 2022 (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 concerning lack of research related to technology-based psychological interventions in individuals with psychosis and cannabis use disorder (CUD) led to the design a randomized control trial (RCT) with an innovative mobile health e-intervention called ICanChange (iCC). Randomized control trials (RCTs) on well-defined samples (limited to psychosis and CUD) are needed to generate evidence on e-health interventions in individuals with psychosis and CUD. As such, an RCT will be conducted to assess the acceptability and feasibility of administering this e-intervention to young people with psychosis who use cannabis. Besides having scarce cannabis interventions adapted for people with psychosis, there are other barriers to addressing problematic cannabis use, such as the challenging and inadequate access to mental health and substance use services by this population. Implementing these and other approaches in the context of a harm reduction intervention or applying other strategies seeking to minimize cannabis-related harms for people who wish to continue using cannabis may be key in helping individuals set realistic goals that are important and relevant to them.
Detailed description
This is a multi-site, two-arm, open-label, pilot randomized control trial, involving 100 young adults diagnosed with psychosis and cannabis use disorder (CUD). Participants will be randomly assigned to either:
Arm 1. Early intervention services (EIS): early intervention for psychosis, including standard of care for psychosis and CUD following Canadian guidelines.
Arm 2. iCC + modified EIS (mEIS): The iCC is an application-based intervention that includes psychotherapeutic modules based on Motivational Interviewing (MI) and Cognitive Behavioral Therapy (CBT). Participants in this arm also receive the same services as in EIS, excluding formal psychotherapeutic interventions for CUD.
Participants will complete assessments at baseline, and at 6, 12, and 24 weeks from baseline.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- two-arm parallel, open-labelled, pilot randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Experimental: CHAMPS and mEIS | Experimental | Behavioral: iCanChangeBrief mobile application-based psychological intervention based on the principles of motivational interviewing (MI) and cognitive behavioural therapy (CBT). This e-intervention will be completed by the participant using a smart phone. There will be up to a maximum of 24 individual sessions (which includes 3 booster sessions) each lasting approximately 10-15 minutes. mEIS: iCC will be administered adjunctively to modified EIS (mEIS), which will include all interventions usually provided through EIS except for any specific psychological interventions (MI, CBT, contingency management) for CUD. |
| No Intervention: EIS alone | No intervention | –Early intervention services will be offered as per standard of care following EIS for psychosis and CUD guidelines, at participating clinical sites. Any visits and services offered in control arm will be considered 'usual care' and administered either through in-person clinic visits, community visits, phone calls, or video calls. Relevant service information will be collected for study purposes. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Young adults age 18 to 35 years old
- Diagnosed with any psychotic disorder, which can include schizophrenia, schizoaffective disorder, bipolar disorder with psychotic features, delusional disorder, psychotic disorder not otherwise specified, brief psychotic disorder and substance-induced psychotic disorder.
- Has been followed at an early psychosis clinic for a minimum of 3 months
- Diagnosed with a current CUD (any severity), based on Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria
- Currently using cannabis (used cannabis at least once in the past month)
Key exclusion criteria (5 listed)
- Any medical condition that in the opinion of the psychiatrist precludes safe participation in the study or the ability to provide fully informed consent
- Any disabling, unstable or acute mental condition that in the opinion of the psychiatrist precludes safe participation in the study or the ability to provide fully informed consent
- Any legal/judicial status/issue, pending legal action, or other reasons in the opinion of the study team that might prevent completion of the study
- Presence of an additional substance use disorder that, in the opinion of the psychiatrist, precludes safe participation in the study (e.g., very unstable or severe substance use disorder)
- Currently participating in another specific cannabis use-focused intervention (other than those which are part of the intervention and control arms)
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 |
|---|---|---|
| iCanChangeiCC is a psychological app based intervention that will be delivered in form of up to 24 brief (10-15 minutes) interactive modules developed based on the principles of Motivational Interviewing (MI) and Cognitive Behavioural Therapy (CBT). During the intervention, participants will be offered MI and CBT-based activities (i.e., modules and strategies) aiming at facilitating change in cannabis use. At any point during the intervention, participants can reference modules that had been completed. Due to the frequency of behavioral stage changes in this population (e.g., regression in behavioral stage of change), stage of change will be monitored regularly throughout the intervention. During the follow-up period (i.e., Week 12-24), participants will have continuous access to the smart phone application and all built-in add-ons as described above. During this period, they will have access to 3 booster session. | Behavioural | Experimental: CHAMPS and mEIS |
Primary outcome
Completion rates
Time frame: Week 12
Number of participants who completed the first section of the intervention and at least one module from section 2 related to achieving their cannabis consumption objectives or with ongoing participation in EIS.
Retention rates
Time frame: Week 12
Proportions of participants retained in the trial (completing all endpoint assessments)
4 secondary outcomes
Acceptability (iCC usage data)
Time frame: Weeks 0-24
Participant satisfaction
Time frame: Weeks 6, 12 & 24
Trial parameters
Time frame: Week -4 to Week 24
Cannabis Use
Time frame: (-2-0 (baseline) and Week 6, 12 & 24
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 23 Dec 2025.
- Derived from this study: PubMed 36427227Tatar O, Abdel-Baki A, Wittevrongel A, Lecomte T, Copeland J, Lachance-Touchette P, Coronado-Montoya S, Cote J, Crockford D, Dubreucq S, L'Heureux S, Ouellet-Plamondon C, Roy MA, Tibbo PG, Villeneuve M, Jutras-Aswad D. Reducing Cannabis Use in Young Adults With Psychosis Using iCanChange, a Mobile Health App: Protocol for a Pilot Randomized Controlled Trial (ReCAP-iCC). JMIR Res Protoc. 2022 Nov 25;11(11):e40817. doi: 10.2196/40817.
- Individual participant dataSharing planned: Yes. Anonymized data sharing procedure will be made developed and made available after completion of the study.
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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.
Didier Jutras-Aswad, MD, MSc principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iCanChange in people with Cannabis Use Disorder, run by Centre hospitalier de l'Université de Montréal (CHUM) at 5 sites 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 10 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: finished, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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. 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?
Completion rates (time frame: Week 12). The study lists 2 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 NCT05310981, 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 Dec 2025.