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

Psychotic Disorder Clinical Trial

— CHAMPS  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04968275
• Other study ID #: 20.433
• Status: Enrolling by invitation
• Phase: N/A
• Start date: August 23, 2021
• Est. completion date: September 30, 2023

Study information

• Verified date: December 2022
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Marijuana Abuse
• Marijuana Use
• Mental Disorders
• Psychotic Disorder
• Psychotic Disorders
• 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.

Locations

Country	Name	City	State
Canada	Foothills Medical Centre Early Psychosis Intervention Program, Unit 24, 1403-29 Street NW	Calgary	Alberta
Canada	Nova Scotia Early Psychosis Program, 3rd Floor, Abbie Lane Bldg 5909 Veterans' Memorial Lane	Halifax	Nova Scotia
Canada	Clinic Connec-T - Institut universitaire en santé mentale de Montréal, 7401 rue Hochelaga	Montreal	Quebec
Canada	Clinique JAP, Centre hospitalier de l'Université de Montréal, 1051, rue Sanguinet	Montreal	Quebec
Canada	Clinic Notre-Dame des Victoires - Centre de Recherche CERVO, 2601 chemin de la Canardière	Québec	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)	Ministere de la Sante et des Services Sociaux

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cannabis-related problems	Total score on the Marijuana Problems Scale	Weeks -2-0 (baseline), 6, 12 and 18
Other	Cannabis use	Past two weeks cannabis use according to the Timeline Follow-Back Questionnaire	Weeks -2-0 (baseline), 6, 12 and 18
Other	Other drug use	Past two weeks other drug use according to the Timeline Follow-Back Questionnaire	Weeks -2-0 (baseline), 6, 12 and 18
Other	Psychotic symptoms	Total score on the Positive and Negative Syndrome Scale	Weeks -2-0 (baseline), 6, 12 and 18
Other	Severity of cannabis dependence	Total score on the Severity of Dependence Scale	Weeks -2-0 (baseline), 6, 12 and 18
Other	Social support	Total score on the Social Provisions Scale	Weeks -2-0 (baseline)
Other	Health service utilization	Past month number of emergency visits and days of hospitalization confirmed by medical record abstraction	Weeks -2-0 (baseline), 6, 12 and 18
Other	Safety (adverse events)	Adverse events and severe adverse events related or not to the study intervention	Weeks 6, 12 and 18
Primary	Completion rates	Proportions of participants completing at least the first four CHAMPS modules or with ongoing participation in EIS.	Week 12
Primary	Retention rates	Proportions of participants retained in the trial (completing all endpoint assessments)	Week 6
Secondary	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	Weeks -2-0 (baseline) to 10
Secondary	Participant satisfaction	Score on the Client Satisfaction Questionnaire-I	Weeks 6 and 12
Secondary	Numbers of participants who are referred, screened, eligible, consenting, randomized, initiating and completing the study	Trial parameters	Weeks -4 to 18
Secondary	Efficacy (use of cannabis protective behavioral strategies)	Change between endpoint and baseline scores on the Short Form Protective Behavioral Strategies-Marijuana questionnaire.	Weeks -2-0 (baseline), 6, 12 and 18
Secondary	Efficacy (motivation to change cannabis protective behavioral strategies)	Change between endpoint and baseline scores on the Readiness-to-Change Questionnaire modified for cannabis use	Weeks -2-0 (baseline), 6, 12 and 18