NCT06733792

Brief Summary

This study aims to develop an App-based intervention (CANQUIT) aimed at regular cannabis users. The efficacy of this intervention will be evaluated in the short-term (1-month follow-up) and long-term (3- and 6-months follow-ups) using a sample of 120 participants. Participants will be randomly assigned to the experimental arm (App-assisted CBT-based intervention) or the control (App-assisted self-help guide). The study will also estimate the economic impact of the intervention by considering the benefit-cost ratio (BCR) and net benefit (in €) associated with the total cost of the program. The goal is to provide evidence that can inform policy decisions regarding cannabis use and minimize the negative consequences on the physical and mental health of young adults in Spain. This study aims to offer a cost-effective prevention strategy that minimize the negative consequences on the physical and mental health of young adults in Spain.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
10mo left

Started Dec 2024

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress63%
Dec 2024Mar 2027

First Submitted

Initial submission to the registry

December 6, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 13, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

December 13, 2024

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

March 30, 2025

Status Verified

March 1, 2025

Enrollment Period

2.2 years

First QC Date

December 6, 2024

Last Update Submit

March 25, 2025

Conditions

Cannabis Dependence

Keywords

CannabisApp-based interventionYoung adultsSelective preventionCBTContingency Management

Outcome Measures

Primary Outcomes (3)

  • Cannabis abstinence

    * Self-reported point prevalence cannabis abstinence * Continuous self-reported cannabis abstinence

    7-day point prevalence abstinence (PP) at 4-week follow-up (FU), 3-months follow-up (FU), 6-months follow-up (FU)

  • Cannabis reduction

    * Self-reported reduction in quantity of cannabis used on a weekly basis (daily joints, number of hashish/marijuana joints, grams) * Decreases in self-reported past-month frequency of cannabis use (i.e., once, less than one per week, once/twice per week, 3-4 times a week, 5-6 times a week, every day).

    4 weeks follow-up (FU), 3 months follow-up (FU), 6 months follow-up (FU)

  • Acceptability

    Client Satisfaction Questionnaire-8 (CSQ-8). The CSQ-8 is an 8-item questionnaire that evaluates the level of satisfaction with the treatment received by the participants. Scores range between 8-32, with higher scores indicating higher levels of satisfaction.

    4-week follow-up (FU)

Secondary Outcomes (3)

  • Changes in legal and illegal substance use

    4 weeks follow-up (FU), 3 months follow-up (FU), 6 months follow-up (FU),

  • Changes in cannabis-related problems

    4-week follow-up (FU), 3-months follow-up (FU), 6-months follow-up (FU)

  • Improvement in risk of emotional disorders

    Changes in 4-week follow-up (FU), 6-months follow-up (FU)

Study Arms (2)

App-assisted CBT-based intervention

EXPERIMENTAL

Participants have access to a 4-week digitalized CBT-based intervention. Participants will have access to seven weekly modules. Modules include cannabis-related psychoeducation (i.e., benefits concerning cannabis use reduction/quitting, short- and long-term consequences, myths), training in emotional regulation strategies, stimulus control (i.e., alternatives to cannabis use), behavioral activation strategies and relapse prevention (i.e., training in assertiveness skills and problem-solving abilities).

Behavioral: CBT-based intervention

App-assisted self-help guide

ACTIVE COMPARATOR

Participants receive a self-help guide based on psychoeducation on cannabis use and its physical/mental health effects.

Behavioral: Self-help guide

Interventions

CBT-based interventionBEHAVIORAL

* 1st week: Daily self-report on cannabis and tobacco use, myths regarding cannabis use and its health consequences, motives for cannabis use reduction/quitting, psychoeducation concerning withdrawal symptomatology, therapist's recommendation (progressive reduction of cannabis use). * 2nd week: Daily self-report on cannabis and tobacco use, myths regarding cannabis use and its health and behavioral consequences, identification of triggers, alternatives to cannabis use, therapist's recommendation (progressive reduction of cannabis use). * 3rd week: Daily self-report on cannabis and tobacco use benefits from quitting cannabis, behavioral activation, diaphragmatic breathing, training in social abilities, strategies to prevent smoking, therapist's recommendation (progressive reduction of cannabis use). * 4th week: Daily self-report on cannabis and tobacco use (i.e., nº of joints/cigarettes), high-risk situations for relapse, lapse vs. relapse, coping strategies, relapse prevention plan.

App-assisted CBT-based intervention
Self-help guideBEHAVIORAL

Psychoeducation on cannabis.

App-assisted self-help guide

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Between 18 and 30 years old.
  • At least one occasion of cannabis use in the last month.
  • Access to smartphones (iOS or Android).
  • Access to Internet.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Faculty of Psychology, University of Oviedo

Oviedo, Principality of Asturias, 33003, Spain

RECRUITING

University of Oviedo

Oviedo, Principality of Asturias, 33003, Spain

ACTIVE NOT RECRUITING

Related Publications (3)

  • Derogatis, L.R. (2001). BSI 18, Brief Symptom Inventory 18: Administration, scoring and Procedure Manual. Pearson.

    BACKGROUND

  • Adamson SJ, Kay-Lambkin FJ, Baker AL, Lewin TJ, Thornton L, Kelly BJ, Sellman JD. An improved brief measure of cannabis misuse: the Cannabis Use Disorders Identification Test-Revised (CUDIT-R). Drug Alcohol Depend. 2010 Jul 1;110(1-2):137-43. doi: 10.1016/j.drugalcdep.2010.02.017. Epub 2010 Mar 26.

    PMID: 20347232BACKGROUND

  • Attkisson CC, Zwick R. The client satisfaction questionnaire. Psychometric properties and correlations with service utilization and psychotherapy outcome. Eval Program Plann. 1982;5(3):233-7. doi: 10.1016/0149-7189(82)90074-x.

    PMID: 10259963BACKGROUND

MeSH Terms

Conditions

Marijuana Abuse

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Central Study Contacts

Alba González-Roz, PhD, Assistant Professor

CONTACT

+34 985104189gonzalezralba@uniovi.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD, Associate Professor

Study Record Dates

First Submitted

December 6, 2024

First Posted

December 13, 2024

Study Start

December 13, 2024

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

March 30, 2025

Record last verified: 2025-03

Locations

ES(2)