- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06733792
A Mobile App to Reduce And/or Quit Cannabis Use (CANQUIT)
Efficacy of a Digitalized Selective Prevention Program (App - "CANQUIT") to Reduce And/or Quit Cannabis Use
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The aim of this study is to evaluate the efficacy and cost-effectiveness in the short (1-month) and long-term (3 and 6 months) of a digitalized intervention (CANQUIT) to reduce and/or quit cannabis among young Spanish adults.
CANQUIT is a 4-week digitalized CBT-based intervention aimed at reducing or ceasing cannabis use among regular cannabis users (at least 1 occasion of cannabis use in the previous month). It is specifically tailored to young adults (18-30 years old). CANQUIT will be available to download both on Apple Store (iOS) and Play Store (Android). Upon completion of the baseline assessment, participants will be randomly assigned 2:1 to either an experimental arm (60 participants: App-assisted CBT-based intervention) or control (60 participants: App-assisted self-help guide). Participants in the experimental arm will be exposed to seven weekly modules, which include: 1) psychoeducation regarding the benefits of ceasing cannabis use, its short and long-term effects and myths associated with its consumption, 2) training in emotion regulation strategies, stimulus control (i.e., alternatives to cannabis use), 3) behavioral activation strategies, and 4) relapse prevention (i.e., assertiveness and problem-solving abilities). Participants will also register daily consumption of cannabis (number of joints) and receive weekly recommendations regarding cannabis use reduction. To ensure adherence to treatment, CANQUIT includes gamification via direct contact with a mental health professional and social interaction with others (through an online chat).
Alternatively, participants allocated to the control group will receive a self-help guide with information based on the contents of the App. This guide will be also available through the App. As in the experimental arm, participants in the control group will also complete 1-month, 3-months and 6-months follow-ups through the App.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Alba González-Roz, PhD, Assistant Professor
- Phone Number: +34 985104189
- Email: gonzalezralba@uniovi.es
Study Locations
-
-
Asturias
-
Oviedo, Asturias, Spain, 33003
- Recruiting
- Faculty of Psychology, University of Oviedo
-
Contact:
- Alba González de la Roz, PhD
- Phone Number: +34 985 10 53 62
- Email: gonzalezralba@uniovi.es
-
Oviedo, Asturias, Spain, 33003
- Active, not recruiting
- University of Oviedo
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: App-assisted CBT-based intervention
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).
|
|
|
Active Comparator: App-assisted self-help guide
Participants receive a self-help guide based on psychoeducation on cannabis use and its physical/mental health effects.
|
Psychoeducation on cannabis.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cannabis abstinence
Time Frame: 7-day point prevalence abstinence (PP) at 4-week follow-up (FU), 3-months follow-up (FU), 6-months follow-up (FU)
|
|
7-day point prevalence abstinence (PP) at 4-week follow-up (FU), 3-months follow-up (FU), 6-months follow-up (FU)
|
|
Cannabis reduction
Time Frame: 4 weeks follow-up (FU), 3 months follow-up (FU), 6 months follow-up (FU)
|
|
4 weeks follow-up (FU), 3 months follow-up (FU), 6 months follow-up (FU)
|
|
Acceptability
Time Frame: 4-week follow-up (FU)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in legal and illegal substance use
Time Frame: 4 weeks follow-up (FU), 3 months follow-up (FU), 6 months follow-up (FU),
|
Self-reported past-month legal and illegal substance use (alcohol, tobacco, cocaine, heroine, amphetamine, ecstasies, hallucinogens, prescription drugs).
|
4 weeks follow-up (FU), 3 months follow-up (FU), 6 months follow-up (FU),
|
|
Changes in cannabis-related problems
Time Frame: 4-week follow-up (FU), 3-months follow-up (FU), 6-months follow-up (FU)
|
Pre to post-intervention changes in cannabis problems as measured by the Cannabis Use Disorder Identification Test-Revised (CUDIT-R).
The CUDIT-R is an 8-item screening test for measuring cannabis-related problems.
Scores of 8 or more are indicative of hazardous cannabis use.
Meanwhile, scores of 12 or more indicate the participant may present a cannabis use disorder.
|
4-week follow-up (FU), 3-months follow-up (FU), 6-months follow-up (FU)
|
|
Improvement in risk of emotional disorders
Time Frame: Changes in 4-week follow-up (FU), 6-months follow-up (FU)
|
Reductions in the severity of symptoms of depression, anxiety, somatization as measured by the Brief Symptoms Inventory-18 (BSI-18).
The BSI-18 is an 18-item assessment screening of psychological distress (somatic, anxious and depressive symptomatology).
Scores range between 0-72, with higher values indicating higher risk of depression, anxiety and somatization.
|
Changes in 4-week follow-up (FU), 6-months follow-up (FU)
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- Derogatis, L.R. (2001). BSI 18, Brief Symptom Inventory 18: Administration, scoring and Procedure Manual. Pearson.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MS-23-PNSD-1
- 2022I002 (Other Grant/Funding Number: Government Delegation for the National Plan on Drugs)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cannabis Dependence
-
Anders Fink-Jensen, MD, DMSciNeurobiology Research Unit, RigshospitaletRecruitingCannabis Dependence | Cannabis Abuse | Cannabis Use Disorder | Cannabis Use Disorders | Cannabis AddictionDenmark
-
Indiana UniversityNational Institute on Drug Abuse (NIDA)RecruitingMarijuana Abuse | Marijuana Use | Addiction | Substance Use | Cannabis Dependence | Substance Use Disorders | Cannabis Use | Substance Abuse | Addiction, Substance | Marijuana Dependence | Substance Dependence | Marijuana Smoking | Cannabis Abuse | Cannabis Use Disorder | Marijuana | Cannabis Intoxication | Substance Related... and other conditionsUnited States
-
University of VirginiaNational Institute on Drug Abuse (NIDA)CompletedCannabis Dependence | Nicotine Dependence | Marijuana Dependence | Cannabis Abuse | Nicotine WithdrawalUnited States
-
Tel-Aviv Sourasky Medical CenterUnknownCannabis Dependence | Psychostimulant DependenceIsrael
-
Centre hospitalier de l'Université de Montréal...CompletedCannabis | Cannabis Dependence | Cannabis Use | Cannabis Smoking | Cannabis Use, UnspecifiedCanada
-
Albert Einstein College of MedicineNational Institute on Drug Abuse (NIDA); National Institute of General Medical...CompletedCannabis Dependence | Tobacco Dependence
-
The Scripps Research InstituteNational Institute on Drug Abuse (NIDA)CompletedAlcohol Dependence | Cannabis Dependence | Alcohol Use Disorder | Cannabis Use DisorderUnited States
-
The Morton Center, Inc.National Institute on Alcohol Abuse and Alcoholism (NIAAA)UnknownAlcohol Dependence | Cannabis Dependence | Alcohol Abuse | Cannabis Abuse | Other Substance AbuseUnited States
-
University of WashingtonNational Institute on Drug Abuse (NIDA)CompletedCannabis Dependence | Cannabis Abuse
-
Assistance Publique - Hôpitaux de ParisTerminatedCannabis Dependence | Cannabis AbuseFrance
Clinical Trials on CBT-based intervention
-
University of CyprusUniversity of CreteUnknown
-
Istituto Auxologico ItalianoCompleted
-
Catholic University of the Sacred HeartLinkoeping University; Istituto Auxologico ItalianoNot yet recruiting
-
NorthShore University HealthSystemCompletedHead and Neck CancerUnited States
-
York UniversityCompletedAn Online CBT, Mindfulness Meditation & Yoga (CBT-MY) Intervention for Posttraumatic Stress DisorderPTSD | Posttraumatic Stress DisordersCanada
-
Per TornvallUppsala University; Mid Sweden UniversityRecruiting
-
Washington University School of MedicineNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)WithdrawnQuality of Life | Weight Loss | Type 2 Diabetes | Mental Health IssueUnited States
-
Seattle Children's HospitalMayo Clinic; National Institute of Diabetes and Digestive and Kidney Diseases... and other collaboratorsCompletedPancreatitis, Chronic | Pancreatitis, Acute RecurrentUnited States
-
Butler HospitalBeth Israel Deaconess Medical Center; National Center for Complementary and... and other collaboratorsNot yet recruiting
-
BrainswayUnknownData Collection for Facilitation of Machine Learning Algorithm for Personalized TreatmentUnited States