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AzTrials

Cannabis Use DisorderCANREDUCENCT04517474

Comparing the Spanish Version of CANreduce With or Without Psychological Support and Treatment as Usual, Reducing Cannabis Use.

A study testing CANreduce and psychological support in people with Cannabis Use Disorder, run by Parc de Salut Mar at 1 site in Spain.

Completed

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

Official record
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Trial summary

Cannabis is the most widely used psychoactive substance around the world after alcohol and tobacco. Although approximately one in ten users develop serious problems of dependency, only a small number attend outpatient addiction counseling centers. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cannabis Use Disorder
What is being tested?
CANreduce and psychological support
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteSpain
Study dates
10 Nov 2020to 1 Dec 2022
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Cannabis use of at least once a week 30 days prior to study entry
  • At least 18 years old
  • At least weekly internet access and a valid email address

Who cannot join

  • Participant reports current pharmacological psychiatric disease or history of psychosis, schizophrenia, bipolar type I disorder or significant current suicidal or homicidal thoughts
  • Use of other pharmacological and psychosocial treatments for cannabis use disorders
  • Inability to read or write in Spanish

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Juan-Ignacio Mestre-Pinto

    Barcelona, Catalonia, 08003

Other trials in Spain

About this study

Official title: Evaluación de Una Herramienta E-Salud Para la reducción Del Consumo de Cannabis

Cannabis is the most widely used psychoactive substance around the world after alcohol and tobacco. Although approximately one in ten users develop serious problems of dependency, only a small number attend outpatient addiction counseling centers. CANreduce is an adherence-focused guidance enhanced web-based self-help program with promising results in German and other languages. It also reaches those users who hesitate to approach such treatment centers and help them to reduce their cannabis use.

This study will test the effectiveness of the Spanish version of the enhanced web-based self-help intervention with psychological support, an enhanced web-based self-help intervention (without psychological support) and a waiting list control in reducing cannabis use in problematic users.

Being tested
CANreduce, psychological support
Keywords
Mental health, Adherence, Treatment, Cognitive behavioral therapy, Web-based Self-Help
Medical subject headings
Psychological Well-Being, Treatment Adherence and Compliance

What participants receive

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

  • CANreduceBehavioural

    Also called CANreduce: Adherence-focused guidance enhanced web-based self-help for the reduction of cannabis use with psychological support

    CANreduce is an automated web-based self-help tool based on classical Cognitive Behavioral Treatment (CBT) approaches for treating cannabis dependence. It will consist of a consumption diary, eight modules designed to reduce cannabis use based on the principles of motivational interviewing, self-control practices, and methods of cognitive behavioral therapy ( strategies for goal achievement, Identifying risk situations, Dealing with cannabis craving, Dealing with relapses, Working on needs, Saying "no" to foster refusal skills, Dealing with burdens, Preserving achievements). Participants can study all modules at their own pace and order, though a specific order will be advised.

  • psychological supportBehavioural

    psychological support

Study groups in NCT04517474
Study groupRoleWhat they receive
CANreduce with psychological supportExperimentalAdherence-focused guidance enhanced web-based self-help for the reduction of cannabis use with psychological support
Receives: Behavioral: CANreduce; Behavioral: psychological support
CANreduce without psychological supportExperimentalAdherence-focused guidance enhanced web-based self-help for the reduction of cannabis use without psychological support
Receives: Behavioral: CANreduce
Treatment as usualNo interventionUsers will be prompt to a web with a list of the treatment centers nearby their postal code

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in the number of days of self-reported cannabis use in the past 30 days (TLFB)

    Participants enter their cannabis consumption frequency into their consumption diary every week.

    More days of self-reported cannabis use indicate worse state

    Measured: Baseline, 6, 12 and 24 weeks.

Secondary outcomes (8)

  1. Change in the number of days of weekly self-reported cannabis use Time Life Follow Back (TLFB)

    Participants enter their cannabis consumption frequency into their consumption diary every week.

    More days of self-reported cannabis use indicate a worse outcome

    Measured: Baseline, 6, 12 and 24 weeks.

  2. Change in the quantity of weekly standard joints (TLFB with predifined cannabis standard joints)

    Participants enter their cannabis consumption quantity into their consumption diary every week.

    More number of weekly standard joints indicate a worse outcome

    Measured: Baseline, 6, 12 and 24 weeks.

  3. Change in the scoring of the Cannabis Use Disorder Identification Test - Revised (CUDIT-R)

    CUDIT-R was developed containing 8 items, two each from the domains of consumption, cannabis problems (abuse), dependence, and psychological features. It has excellent psychometric properties. High sensitivity (91%) and specificity (90%).

    This questionnaire was designed for self administration and is scored by adding each of the 8 items:

    • Question 1-7 are scored on a 0-4 scale (range 0-28)
    • Question 8 is scored 0, 2 or 4.
    • Score range 0-32 Scores of 8 or more indicate hazardous cannabis use, while scores of 12 or more indicate a possible cannabis use disorder for which further intervention may be required.

    Higher scores indicate a worse outcome

    Measured: Baseline, 6, 12 and 24 weeks.

  4. Change in the scoring of the Severity Dependence Scale (SDS)

    SDS is a standard instrument to assess the severity to any drug dependence. Each of the five items is scored on a 4-point scale (0-3). The total score is obtained through the addition of the 5-item ratings (0-15). The higher the score the higher the level of dependence.

    Measured: Baseline, 6, 12 and 24 weeks.

  5. Change in the scoring of the Alcohol Use Disorders Identification Test (AUDIT)

    AUDIT is a 10-item screening tool developed by the World Health Organization (WHO) to assess alcohol consumption, drinking behaviors, and alcohol-related problems. Each item scores 0-4, The total score ranges from 0-40. A score of 8 or more is considered to indicate hazardous or harmful alcohol use. The AUDIT has been validated across genders and in a wide range of racial/ethnic groups and is well suited for use in primary care settings. Higher scores indicate a worse outcome

    Measured: Baseline, 6, 12 and 24 weeks.

  6. Change in the scoring of the PROMIS Emotional Distress - Depression - Short Form 8b

    PROMIS (Patient-Reported Outcomes Measurement Information System) is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. It can be used with the general population and with individuals living with chronic conditions. Developed and validated with state-of-the-science methods to be psychometrically sound and to transform how life domains are measured.

    8 items 1-5, score ranges 8-40 Higher scores indicate a worse outcome

    Measured: Baseline, 6, 12 and 24 weeks.

  7. Change in the scoring of the PROMIS Anxiety 8a - Adult v1.0

    PROMIS (Patient-Reported Outcomes Measurement Information System) is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. It can be used with the general population and with individuals living with chronic conditions. Developed and validated with state-of-the-science methods to be psychometrically sound and to transform how life domains are measured.

    8 items 1-5, score ranges 8-40 Higher scores indicate a worse outcome

    Measured: Baseline, 6, 12 and 24 weeks.

  8. Change in the scoring of the EQ-5D-5L

    EQ-5D-5L is a self-assessed, health related, quality of life questionnaire. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.

    Score ranges from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health),

    The second part of the questionnaire consists of a visual analogue scale (VAS) on which the patient rates his/her perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health).

    Measured: Baseline, 6, 12 and 24 weeks.

Timeline

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

  1. First posted18 Aug 2020
  2. Study start10 Nov 2020
  3. Primary completion1 Nov 2022
  4. Study completion1 Dec 2022

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04517474
Sponsor's protocol ID
2019/8901/I
Acronym
CANREDUCE
Status last verified
Nov 2021
First submitted
12 Aug 2020
Last updated
16 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Amann M, Haug S, Wenger A, Baumgartner C, Ebert DD, Berger T, Stark L, Walter M, Schaub MP. The Effects of Social Presence on Adherence-Focused Guidance in Problematic Cannabis Users: Protocol for the CANreduce 2.0 Randomized Controlled Trial. JMIR Res Protoc. 2018 Jan 31;7(1):e30. doi: 10.2196/resprot.9484.

    PubMed 29386176

  • Schaub MP, Wenger A, Berg O, Beck T, Stark L, Buehler E, Haug S. A Web-Based Self-Help Intervention With and Without Chat Counseling to Reduce Cannabis Use in Problematic Cannabis Users: Three-Arm Randomized Controlled Trial. J Med Internet Res. 2015 Oct 13;17(10):e232. doi: 10.2196/jmir.4860.

    PubMed 26462848

  • Mestre-Pinto JI, Fonseca F, Schaub MP, Baumgartner C, Alias-Ferri M, Torrens M. CANreduce-SP-adding psychological support to web-based adherence-focused guided self-help for cannabis users: study protocol for a three-arm randomized control trial. Trials. 2022 Jun 22;23(1):524. doi: 10.1186/s13063-022-06399-2.

    PubMed 35733201

Questions about this trial

What is this clinical trial studying?

A study testing CANreduce and psychological support in people with Cannabis Use Disorder, run by Parc de Salut Mar at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. 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 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. 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?

Change in the number of days of self-reported cannabis use in the past 30 days (TLFB) (time frame: Baseline, 6, 12 and 24 weeks.). 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 NCT04517474, which also lists 3 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 Sep 2026.

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