AzTrials
AzTrials

Psychotic DisorderCHAMPSNCT04968275

A Cannabis Harm Reduction e-Intervention for Young Cannabis Users With Early Psychosis

A study testing CHAMPS in people with Psychotic Disorder and Marijuana Use, run by Centre hospitalier de l'Université de Montréal (CHUM) at 5 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Cannabis users who experienced a psychosis are particularly vulnerable to cannabis-related harms, which can include worse psychotic symptoms and more hospitalizations. Unfortunately, few psychosocial interventions exist that aim to decrease these harms. Read more about this study

Who is it for?
Ages 18 to 35 years
Conditions the study is for
Psychotic Disorder, Marijuana Use, Young Adult
What is being tested?
CHAMPS
Could I receive a placebo?
No, everyone receives an active treatment
How many people
101 participants
Where
5 sitesCanada
Study dates
23 Aug 2021to 24 Oct 2023
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

Participants must meet all following inclusion criteria:

  • 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;
  • currently using cannabis (at least one time in the past 4 weeks);
  • is open to changing cannabis-related practices;
  • able to provide full informed consent;
  • available for the whole study duration and able to comply with study procedures;
  • able to comprehend French or English.

Participants are excluded if any of these exclusion criteria is met:

  • pregnancy, nursing or 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 a 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 seeking psychological or pharmacological treatment for cannabis use disorder to cease or decrease his/her use;
  • currently participating in another specific cannabis-focused intervention.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Canada5 sites

  • Foothills Medical Centre Early Psychosis Intervention Program, Unit 24, 1403-29 Street NW

    Calgary, Alberta, T2N 2T9

  • Nova Scotia Early Psychosis Program, 3rd Floor, Abbie Lane Bldg 5909 Veterans' Memorial Lane

    Halifax, Nova Scotia, B3H 2E2

  • Clinic Connec-T - Institut universitaire en santé mentale de Montréal, 7401 rue Hochelaga

    Montreal, Quebec, H1N 3M5

  • Clinique JAP, Centre hospitalier de l'Université de Montréal, 1051, rue Sanguinet

    Montreal, Quebec, H2X 3E4

  • Clinic Notre-Dame des Victoires - Centre de Recherche CERVO, 2601 chemin de la Canardière

    Québec, Quebec, G1J 2G3

Other trials in Canada

About this study

Official title: A Randomized Pilot Trial of a Cannabis Harm Reduction e-Intervention (CHAMPS) for Young Adults With Early Psychosis Who Use Cannabis

Cannabis users who experienced a psychosis are particularly vulnerable to cannabis-related harms, which can include worse psychotic symptoms and more hospitalizations. Unfortunately, few psychosocial interventions exist that aim to decrease these harms. Instead, most focus on ceasing cannabis use which is rarely appealing to cannabis users. Furthermore, face-to-face psychotherapy often remains inaccessible to people with psychosis mostly due to lack of trained clinicians. Alternatives such as e-interventions have the potential to increase access to treatment and decrease clinicians' workload. Among cannabis harm reduction approaches are the protective behavioural strategies. These strategies do not encourage nor discourage cannabis use. Instead, they recommend behaviours for safer cannabis use. For example, these strategies include: 1) avoid driving a car under the influence of cannabis, 2) avoid mixing cannabis with other drugs and 3) purchase cannabis only from a trusted source. In the present pan-Canadian study, we will test the first e-intervention called CHAMPS (Cannabis Harm-reducing App for Managing Practices Safely) for cannabis harm reduction adapted for young adult cannabis users who experienced a psychosis. CHAMPS is a smartphone application that includes 17 strategies for safer cannabis use, a personalized consumption goal and a consumption journal. The goals of this study are 1) to confirm whether CHAMPS is acceptable to participants and 2) to test whether it works, notably by positively impacting participants' health and cannabis consumption habits.

Read the detailed description

This multicentric, two-arm, open-labelled, pilot randomized controlled trial involves 100 young cannabis users who experienced a psychosis and are followed in an early intervention service (EIS) in Canada. Participants will be randomized in a 1:1 ratio to one of two interventions:

  • CHAMPS and EIS
  • EIS alone

The smartphone application CHAMPS contains six modules (each lasting 15-20 min, weeks 1 to 6) and a booster session (20 min, week 10) based on motivational interviewing and harm reduction approaches. EIS consists of standard of care and psychoeducation material on cannabis use offered in first episode psychosis clinics and administered through in-person visits and/or phone or video calls.

All participants will be assessed for a follow-up at weeks 6, 12 and 18. Data on mental health, substance use, cannabis dependence severity, cannabis-related problems, quality of life and health care service utilization will be obtained through questionnaires and medical charts.

Being tested
CHAMPS
Keywords
Psychosis, Cannabis, Youth
Medical subject headings
Psychotic Disorders, Marijuana Use, Marijuana Abuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CHAMPSBehavioural

    Also called Technology-based psychosocial intervention, Psychotherapy

    CHAMPS provides personalized feedback on participants' cannabis use behaviors and supports strategies to change such behaviors. It comprises six modules measuring the use of cannabis protective behavioural strategies, exploring the possible benefits of changing cannabis practices and setting and monitoring the reach of a SMART cannabis use goal.

Study groups in NCT04968275
Study groupRoleWhat they receive
CHAMPS and EISExperimentalThe Cannabis Harm-reducing App for Managing Practices Safely (CHAMPS) is a brief harm reduction e-intervention based on the principles of motivational interviewing and harm reduction approaches. This e-intervention will be completed by the participant using a smart phone. There will be a total of six individual sessions each lasting 15-20 min. There will be one booster session offered at 4 weeks post-intervention to review goal setting, evaluate motivation around changing cannabis use practices. This e-intervention will be administered adjunctively to psychosis early intervention services (EIS).
Receives: Behavioral: CHAMPS
EIS aloneNo interventionEarly intervention services (EIS) for psychosis will be offered as per standard of care at participating clinical sites. Theses services vary but typically include pharmacotherapy and individual and/or group psychotherapy. Any visits and services offered in the EIS arm will be considered 'usual care' and administered either through in-person clinic 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.

  1. Completion rates

    Proportions of participants completing at least the first four CHAMPS modules or with ongoing participation in EIS.

    Measured: Week 12

  2. Retention rates

    Proportions of participants retained in the trial (completing all endpoint assessments)

    Measured: Week 6

Secondary outcomes (5)

  1. Acceptability (CHAMPS usage data)

    Number of CHAMPS modules completed, time spent on each module, time elapsed between module initiation and completion, total time spent on CHAMPS

    Measured: Weeks -2-0 (baseline) to 10

  2. Participant satisfaction

    Score on the Client Satisfaction Questionnaire-I

    Measured: Weeks 6 and 12

  3. Numbers of participants who are referred, screened, eligible, consenting, randomized, initiating and completing the study

    Trial parameters

    Measured: Weeks -4 to 18

  4. Efficacy (use of cannabis protective behavioral strategies)

    Change between endpoint and baseline scores on the Short Form Protective Behavioral Strategies-Marijuana questionnaire.

    Measured: Weeks -2-0 (baseline), 6, 12 and 18

  5. Efficacy (motivation to change cannabis protective behavioral strategies)

    Change between endpoint and baseline scores on the Readiness-to-Change Questionnaire modified for cannabis use

    Measured: Weeks -2-0 (baseline), 6, 12 and 18

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2021
  2. Study start23 Aug 2021
  3. Primary completion30 Sep 2023
  4. Study completion24 Oct 2023

Resources

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
101 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04968275
Sponsor's protocol ID
20.433
Acronym
CHAMPS
Status last verified
May 2024
First submitted
9 Jul 2021
Last updated
16 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Mahroug A, Lachance-Touchette P, Coronado-Montoya S, Abdel-Baki A, Cote J, Crocker C, Crockford DN, Daneault JG, Dubreucq S, Dussault-Laurendeau M, Fischer B, Lecomte T, L'Heureux S, Ouellet-Plamondon C, Roy MA, Tatar O, Tibbo PG, Villeneuve M, Wittevrongel A, Jutras-Aswad D. Correlates of Engagement and Associations With Outcomes in a Cannabis Harm-Reduction Mobile App for Youth With First-Episode Psychosis: Exploratory Analysis of the CHAMPS Pilot Randomized Controlled Trial. JMIR Form Res. 2026 Aug 4;10:e84836. doi: 10.2196/84836.

    PubMed 42550986

  • Coronado-Montoya S, Abdel-Baki A, Cote J, Crockford D, Dubreucq S, Fischer B, Lachance-Touchette P, Lecomte T, L'Heureux S, Ouellet-Plamondon C, Roy MA, Tatar O, Tibbo P, Villeneuve M, Wittevrongel A, Jutras-Aswad D. Evaluation of a Cannabis Harm Reduction Intervention for People With First-Episode Psychosis: Protocol for a Pilot Multicentric Randomized Trial. JMIR Res Protoc. 2023 Dec 18;12:e53094. doi: 10.2196/53094.

    PubMed 38109196

Questions about this trial

What is this clinical trial studying?

A study testing CHAMPS in people with Psychotic Disorder and Marijuana Use, 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?

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 16 May 2024. 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 NCT04968275, which also lists 2 linked publications.

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 16 May 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in