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

• ClinicalTrials.gov Identifier: NCT04968275
• Recruitment Status: Enrolling by invitation
• First Posted: July 20, 2021
• Last Update Posted: December 13, 2022
• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Collaborator: Ministere de la Sante et des Services Sociaux
• Information provided by (Responsible Party): Centre hospitalier de l'Université de Montréal (CHUM)

Tracking Information

• First Submitted Date: July 9, 2021
• First Posted Date: July 20, 2021
• Last Update Posted Date: December 13, 2022
• Actual Study Start Date: August 23, 2021
• Estimated Primary Completion Date: September 30, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 19, 2021)

• Completion rates [ Time Frame: Week 12 ]
  Proportions of participants completing at least the first four CHAMPS modules or with ongoing participation in EIS.
• Retention rates [ Time Frame: Week 6 ]
  Proportions of participants retained in the trial (completing all endpoint assessments)

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 19, 2021)

• Acceptability (CHAMPS usage data) [ Time Frame: Weeks -2-0 (baseline) to 10 ]
  Number of CHAMPS modules completed, time spent on each module, time elapsed between module initiation and completion, total time spent on CHAMPS
• Participant satisfaction [ Time Frame: Weeks 6 and 12 ]
  Score on the Client Satisfaction Questionnaire-I
• Numbers of participants who are referred, screened, eligible, consenting, randomized, initiating and completing the study [ Time Frame: Weeks -4 to 18 ]
  Trial parameters
• Efficacy (use of cannabis protective behavioral strategies) [ Time Frame: Weeks -2-0 (baseline), 6, 12 and 18 ]
  Change between endpoint and baseline scores on the Short Form Protective Behavioral Strategies-Marijuana questionnaire.
• Efficacy (motivation to change cannabis protective behavioral strategies) [ Time Frame: Weeks -2-0 (baseline), 6, 12 and 18 ]
  Change between endpoint and baseline scores on the Readiness-to-Change Questionnaire modified for cannabis use

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: July 19, 2021)

• Cannabis-related problems [ Time Frame: Weeks -2-0 (baseline), 6, 12 and 18 ]
  Total score on the Marijuana Problems Scale
• Cannabis use [ Time Frame: Weeks -2-0 (baseline), 6, 12 and 18 ]
  Past two weeks cannabis use according to the Timeline Follow-Back Questionnaire
• Other drug use [ Time Frame: Weeks -2-0 (baseline), 6, 12 and 18 ]
  Past two weeks other drug use according to the Timeline Follow-Back Questionnaire
• Psychotic symptoms [ Time Frame: Weeks -2-0 (baseline), 6, 12 and 18 ]
  Total score on the Positive and Negative Syndrome Scale
• Severity of cannabis dependence [ Time Frame: Weeks -2-0 (baseline), 6, 12 and 18 ]
  Total score on the Severity of Dependence Scale
• Social support [ Time Frame: Weeks -2-0 (baseline) ]
  Total score on the Social Provisions Scale
• Health service utilization [ Time Frame: Weeks -2-0 (baseline), 6, 12 and 18 ]
  Past month number of emergency visits and days of hospitalization confirmed by medical record abstraction
• Safety (adverse events) [ Time Frame: Weeks 6, 12 and 18 ]
  Adverse events and severe adverse events related or not to the study intervention

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

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

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.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

two-arm parallel, open-labelled, pilot randomized controlled trial

Masking: None (Open Label)
Masking Description:

Group assignment will not be masked after randomization, but it will be at the data analysis stage.

Primary Purpose: Prevention

Condition

• Psychotic Disorder
• Marijuana Use
• Young Adult

Intervention

Behavioral: CHAMPS

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.

Other Names:

• Technology-based psychosocial intervention
• Psychotherapy

Study Arms

• Experimental: CHAMPS and EIS
  The 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).
  Intervention: Behavioral: CHAMPS
• No Intervention: EIS alone
  Early 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.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Enrolling by invitation
• Estimated Enrollment (submitted: July 19, 2021): 100
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 30, 2023
• Estimated Primary Completion Date: September 30, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 35 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT04968275
• Other Study ID Numbers: 20.433
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
• Original Responsible Party: Same as current
• Current Study Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Original Study Sponsor: Same as current
• Collaborators: Ministere de la Sante et des Services Sociaux

Investigators

• Principal Investigator: Didier Jutras-Aswad, MD, MSc; Centre hospitalier de l'Université de Montréal (CHUM)

• PRS Account: Centre hospitalier de l'Université de Montréal (CHUM)
• Verification Date: December 2022