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Can CBD replace antipsychotics for cannabis users with psychosis?

NCT ID NCT04105231

Disease control Sponsor: Lone Baandrup Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares cannabidiol (CBD) to the standard antipsychotic risperidone in 64 adults with schizophrenia or related psychotic disorders who have used cannabis. The goal is to see if CBD can reduce psychotic symptoms and help people stop or cut down cannabis use. Participants receive either CBD or risperidone for several weeks, and their symptoms and cannabis use are tracked.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 64 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2021

Expected to finish

Mar 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria: * ICD-10 diagnosis of schizophrenia (DF20.X), paranoid psychosis (DF22.X), acute/intermittent psychotic disorder (DF23.X), schizoaffective psychosis (DF25.X), other/not specified nonorganic psychotic disorder (DF28/DF29), or cannabis induced psychotic disorder (DF12.5) * PANSS ≥ 60 and score of ≥ 4 on ≥ 2 PANSS-Positive subscale items: Delusions (P1), conceptual disorganization (P2), hallucinatory behaviour (P3), grandiosity (P5), suspiciousness (P6) * Lifetime cannabis use * Age 18-45 years * Female patients of childbearing potential need to utilize a proper method of contraception Exclusion criteria: * Treatment resistance as defined by treatment (ever) with clozapine * Dependence syndrome of alcohol or psychoactive substances other than cannabis (DF1X.2 other than DF12.2) * Psychotic disorder induced by alcohol or psychoactive substances other than cannabis (DF1X.5 other than DF12.5) * Treatment with a long-acting injectable antipsychotic within the past month (or corresponding to the usual interval between two injections) * Treatment with an oral antipsychotic within the past 7 days * Use of self-administered CBD products during the trial * Patients involuntarily admitted * Pregnancy or lactation * Severe physical illness that might influence the ability to comply with the protocol

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Conditions

The condition(s) this trial relates to.

cannabis dependence drug psychosis paranoid schizophrenia Psychotic Disorders schizoaffective disorder schizophrenia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Dual diagnosis

Contacts and locations

Locations

  • Center for Neuropsychiatric Schizophrenia Research

    Glostrup Municipality, 2600, Denmark

More trials for these conditions

Other studies related to the condition(s) this trial covers.