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Completed

NCT Number: NCT04968275

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

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.

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Key information

Conditions

Psychotic Disorder Behavior Chemically-Induced Disorders Marijuana Abuse Marijuana Use Mental Disorders Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders Substance-Related Disorders Young Adult

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Foothills Medical Centre Early Psychosis Intervention Program, Unit 24, 1403-29 Street NW, Calgary, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CHAMPS

Behavioral

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

Primary outcomes

  1. Completion rates

    Time frame: Week 12

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

  2. Retention rates

    Time frame: Week 6

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

Secondary outcomes

  1. 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

  2. Participant satisfaction

    Time frame: Weeks 6 and 12

    Score on the Client Satisfaction Questionnaire-I

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

    Time frame: Weeks -4 to 18

    Trial parameters

  4. 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.

  5. 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

Other outcomes

  1. Cannabis-related problems

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

    Total score on the Marijuana Problems Scale

  2. Cannabis use

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

    Past two weeks cannabis use according to the Timeline Follow-Back Questionnaire

  3. 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

  4. Psychotic symptoms

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

    Total score on the Positive and Negative Syndrome Scale

  5. Severity of cannabis dependence

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

    Total score on the Severity of Dependence Scale

  6. Social support

    Time frame: Weeks -2-0 (baseline)

    Total score on the Social Provisions Scale

  7. 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

  8. Safety (adverse events)

    Time frame: Weeks 6, 12 and 18

    Adverse events and severe adverse events related or not to the study intervention

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Collaborators

  • Ministere de la Sante et des Services Sociaux

Registry information

Official study title

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

Acronym: CHAMPS

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 20, 2021
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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