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| ID | Type | Description | Link |
|---|---|---|---|
| 10001E_220072 | Other Grant/Funding Number | Swiss National Science Foundation |
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| Name | Class |
|---|---|
| Swiss National Science Foundation | OTHER |
| Apptitude | UNKNOWN |
| Addiction Switzerland | UNKNOWN |
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The goal of this clinical trial is to learn if a digital web application can prevent the risks related to cannabis use among adult regular cannabis users who are enrolled in a pilot trial for cannabis sales regulation conducted in Lausanne, Switzerland (i.e., Cann-L study) and have agreed that their data were used in other studies.
The main question it aims to answer is:
Do participants who have access to the intervention modules of the web application raise their use of protective behavioral strategies to lower cannabis-related risks?
Researchers will compare the intervention modules to a control module (i.e., information on cannabis-related risks and harm reduction) to see if the web application works to prevent the risks related to cannabis use. They will also compare intervention modules across each other to see whether one works better than another.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Condition 1 - Personalized Feedback + Information | Experimental | Access to "Personalized Feedback" module (PF, Study Intervention) and "Information" module (Minimal, Control Intervention) |
|
| Condition 2 - Imagine the future + Information | Experimental | Access to "Imagine the Future" module (IMAGIN, Study Intervention) and "Information" module (Minimal, Control Intervention) |
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| Condition 3 - Substance-Free Activities Session + Information | Experimental | Access to "Substance-Free Activities Session" module (SFAS, Study Intervention) and "Information" module (Minimal, Control Intervention) |
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| Condition 4 - Full Intervention + Information | Experimental | Access to the full intervention (PF+IMAGIN+SFAS) and "Information" module (Minimal, Control Intervention) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Personalized Feedback on Cannabis Protective Behavioral Strategies, Cannabis Use, Cannabis Expenditures, and Cannabis-Related Consequences (PF) | Behavioral | PF comprises the following content:
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| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Protective Behavioral Strategies for Marijuana Use as Measured by the PBSM-17 Short Form Scale | This outcome will be measured using the Protective Behavioral Strategies for Marijuana Use (PBSM-17) Short Form scale, a self-reported 17-item questionnaire measuring the frequency of PBS for cannabis use on a 6-point Likert scale ranging from 1 (never) to 6 (always). | This outcome will be assessed at 1- and 7-month follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| Cannabis Use Frequency | Cannabis Use Frequency will be measured using a single item asking "During the past 30 days, on how many days did you use cannabis?" | This outcome will be measured at 1- and 7-month follow-up. |
| Number of Hours High on a Typical Day |
| Measure | Description | Time Frame |
|---|---|---|
| Cannabis Use Disorder Severity as Measured by CUDIT-R | This outcome will be measured using the Cannabis Use Disorder Identification Test - Revised (CUDIT-R), a self-reported 8-items questionnaire (i.e., question 1-7 are scored on a 0-4 scale, and question 8 is scored 0, 2, or 4). 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. |
Inclusion Criteria:
Inclusion criteria in Cann-L study are:
Exclusion Criteria:
The consent to participate in the Cann-L parent trial comprises an option to be contacted to participate in sub-studies, including studies on prevention measures. All participants having accepted to be so contacted will be proposed to participate in the present study.
Therefore, additional exclusion criteria for the present study include:
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| Name | Affiliation | Role |
|---|---|---|
| Jacques Gaume, PhD | University of Lausanne Hospitals | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lausanne University Hospital | Lausanne | Vaud Canton | 1011 | Switzerland |
The data collected for this study may be reused and/or transmitted for other studies (including abroad), always in coded form (i.e., deidentified dataset). For each instance of reuse in another study, a data transfer agreement will need to be established.
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Beginning immediately after the publication of results and ending 20 years after study termination.
A formal request should be submitted to the Principal investigator and a data sharing agreement must be signed.
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Monocentric 5-arm fractional factorial randomized controlled trial.
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The randomization will be imbedded within the application, therefore concealment of allocation will be total. Participants will be blind to their experimental condition. Research staff involved in the study will not be informed of participants' group allocation. All study assessments will be done electronically. The generation of the randomization sequence and its programing into the study website will be conducted by the developing team who will not have contacts with participants or any involvement in the study implementation and analyses.
| Condition 5 - Information only (Control) | Active Comparator | Access to "Information" module (Minimal, Control Intervention) |
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| Imagining the Future Using Counterfactual Thinking and Episodic Future Thinking (IMAGIN) | Behavioral | Two-task intervention including:
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| Behavioral Economics-Informed Exercises to Increase Motivation to Engage in Substance-Free Activities (SFAS) | Behavioral | SFAS includes:
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| Information | Behavioral | Minimal intervention (Control Intervention), consisting of simple, text-only web pages containing information on cannabis effects and health-related risks, cannabis consumption modes, cannabis harm reduction and protective behavioral strategies, as well as hyperlinks to additional resources and online help. |
|
The number of hours under influence will be measured using a single item asking "How many total hours were you high on a typical day when you had been using cannabis?" |
| This outcome will be measured at 1- and 7-month follow-up. |
| This outcome will be measured at 1- and 7-month follow-up. |
| Cannabis Purchase Task | This outcome will be used to measure behavioral economics indices of cannabis demand. Participants will be asked to report hypothetical cannabis consumption in a scenario at escalating prices. | This outcome will be assessed at 1- and 7-month follow-up. |
| Source of Cannabis Supply | This outcome will be measured for each cannabis product (herbal/marijuana, resin/hashish, oral oil, e-liquids, concentrates, edibles, other) by reporting the frequency of supply in a) Cann-L study dispensary, b) other external sources (e.g., acquaintances, on the street, social networks, darknet). | This outcome will be assessed at 1- and 7-month follow-up. |
| Alternatives to Smoking Cannabis | The frequency of use of four main consumption modes (smoking, vaping/dabbing, absorbing, and edibles) will be measured using four corresponding cursors for which the total should be 100%. | This outcome will be assessed at 1- and 7-month follow-up. |
| Purchase of Cannabis with Lower THC Ratio | This outcome will be computed based on individual sales data from Cann-L study dispensary. | This outcome will be assessed at 1- and 7-month follow-up. |
| Simultaneous Use of Cannabis and Other Substances | This outcome will be assessed by two items measuring the frequency of simultaneous use, one for alcohol and one for other illegal drugs. | This outcome will be assessed at 1- and 7-month follow-up. |
| ID | Term |
|---|---|
| D040261 | Harm Reduction |
| ID | Term |
|---|---|
| D001519 | Behavior |
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